Mataró, Barcelona, Spain

Nurse-led High-flow Nasal Cannula Weaning Protocol in Pediatric Intensive Care Unit

Bronchiolitis is a leading cause of pediatric hospital admissions. While high-flow nasal cannula (HFNC) is effective as a rescue therapy for patients with severe respiratory distress when standard oxygen therapy fails, studies suggest that early use of HFNC in moderate cases does not significantly improve outcomes such as hospital stay duration or intubation rates. Despite its limited clinical benefits, the use of HFNC in children with bronchiolitis is increasing, raising concerns about unnecessary treatment and extended hospital stays due to a lack of standardized weaning protocols. Evidence suggests that HFNC should be used effectively as a rescue treatment after standard oxygen therapy fails, serving as an intermediate step before invasive support. However, the high costs and self-limiting nature of bronchiolitis necessitate reducing the overuse of HFNC in hospitalized children. Previous studies using quality improvement (QI) methodologies have successfully reduced HFNC usage through weaning protocols and trials of standard oxygen therapy. This study involves implementing an HFNC initiation and weaning protocol at Aydın Maternity and Children's Hospital, involving infants aged 1-24 months admitted with bronchiolitis. A multidisciplinary team will evaluate patients using the Respiratory Assessment Scale (RAS), with mild, moderate, and severe classifications. The study compares HFNC duration, hospital stay, oxygen support duration, and associated costs before and after the protocol implementation. Exclusion Criteria: Premature infants born at less than 32 weeks Patients with cardiopulmonary, genetic, congenital, or neuromuscular abnormalities were excluded. A prospective, randomized controlled trial will be conducted to evaluate the effectiveness of a newly developed HFNC (High-Flow Nasal Cannula) weaning protocol in infants aged 1-24 months with bronchiolitis, compared to the standard weaning protocol. The new HFNC weaning protocol was developed using Quality Improvement (QI) methodology, involving input from pediatricians, nurses, and hospital staff through training sessions. The training lasted one month before the implementation, focusing on classifying patients using the Respiratory Assessment Scale (RAS), which includes respiratory rate, the workload of breathing, and consciousness level. A multidisciplinary team will apply the protocol. Protocol for Bronchiolitis in Children Under 2 Years: Aspiration, postural drainage, hydration, antipyretics if necessary, nasal cannula for SpO₂ drop (3-4 L/min) Despite nasal cannula >3 LPM (FiO₂: 32), hypoxemia (≤92% FiO₂) or moderate-to-severe RAS: Yes: Start HFNC (High-Flow Nasal Cannula) therapy. No: Continue with HFNC or nasal cannula/mask. HFNC Therapy Initiation: Initial FiO₂: 50%, Flow rate: 1-2 L/kg Target SpO₂ between 92-96% by titrating FiO₂. Calculate the baseline ROX index. Reassess in 30-60 minutes: Is there clinical deterioration? (Moderate-to-severe RAS) If clinical deterioration is present: FiO₂ ≥ 50% SpO₂ < 90% pCO₂ ≥ 60 Positive pressure ventilation should be considered if there is apnea or bradycardia. If there is no clinical deterioration: After 4 hours of stable condition, reassess. Is there improvement in RAS and ROX index, and is the patient clinically stable? Yes: If FiO₂ < 30%, start weaning the flow rate and FiO₂ simultaneously. Reduce the flow rate by 2 L/min every 2-4 hours, and evaluate the RAS-ROX trend every 2-4 hours. If there is respiratory deterioration: Continue or increase HFNC flow rate and FiO₂ as needed. If there is no respiratory deterioration: Weaning continues. Discontinue HFNC when the flow rate reaches 4 L/min and FiO₂ < 30%. Is there respiratory deterioration? Yes: Return to the previous flow rate, and reassess within 30 minutes. Randomization and Groups: Participants will be randomly assigned to one of two groups: Control Group: Will follow the existing HFNC weaning protocol. Intervention Group: The intervention group will follow the newly developed multidisciplinary HFNC weaning protocol. Outcomes: The 2 groups will be compared regarding HFNC duration, hospital stay, oxygen support duration, intensive care readmission, noninvasive ventilation (NIV) needs, intubation rates, and costs.

Time for a Diagnostic Paradigm Shift From STEMI/NSTEMI to OMI/NOMI

I. BACKGROUND AND SIGNIFICANCE The patients with acute coronary occlusion (ACO) or potentially imminent occlusion, with insufficient collateral circulation, have myocardium that is at risk of infarction unless they undergo immediate reperfusion via thrombolytics or percutaneous coronary intervention (PCI). One of the most important tasks in emergency cardiology is to immediately identify acute coronary occlusion (ACO) myocardial infarction (OMI) among all patients who present with symptoms compatible with acute myocardial infarction (MI), and distinguish them from those without MI, and from those with MI that does not have ongoing myocyte loss (Non-OMI, or NOMI) who can be managed with medical therapy and for whom potentially harmful invasive interventions can be deferred. The electrocardiogram (ECG) plays a central role in this process. The presence or absence of ST-segment elevation (STE) is principally used to define patients who need emergent coronary revascularization, since subgroup analyses of the Fibrinolytic Therapy Trialists' (FTT) meta-analysis indicated that patients with STE on ECG gain a slightly better survival benefit from emergent reperfusion. After fine-tuning of STE cutoffs used in this analysis, universally agreed STEMI criteria became the current guideline-supported ECG paradigm. It is not clear why a disease of a known pathophysiology (ACO) was named with an inaccurate surrogate ECG sign (Q-wave MI/non-Q-wave MI or STEMI/non-STEMI) instead of the pathologic substrate itself (ACO-MI/non-ACO-MI or OMI for short), but this fundamental mistake created important implications for our current practice. As briefly outlined above, ACO can be reliably recognized with the help of many other ECG findings, such as minor STE not fulfilling STEMI criteria, STE disproportionate to preceding QRS, unusual patterns with contiguous leads showing opposite ST deviations and some patterns not showing STE at all. Recently, the DIagnostic accuracy oF electrocardiogram for acute coronary OCClUsion resuLTing in myocardial infarction (DIFOCCULT) study, compared OMI/non-OMI approach with STEMI/non-STEMI paradigm. This is the largest study specifically designed to question the STEMI/non-STEMI paradigm, in which a set of predefined ECG findings in addition to STEMI criteria were used, and the final outcome was a composite ACO endpoint. In accordance with the previous observations, over one-fourth of the patients initially classified as having non-STEMI were re-classified by the ECG reviewers, blinded to all outcome data, as having OMI. This subgroup had a higher frequency of ACO, myocardial damage, and both in-hospital and long-term mortality compared to the non-OMI group. The OMI/non-OMI approach to the ECG had a superior diagnostic accuracy compared to the STE/non-STEMI approach in the prediction of both ACO and long-term mortality. II. THE HYPOTHESIS Our hypothesis is that the new OMI/NOMI approach will be superior to the established STEMI/NSTEMI paradigm in early detection of ACO, limiting infarct size, reducing rehospitalizations and most important of all, reducing mortality. III. METHODS 1. Application for Institutional Review Board (IRB)/Ethics board approval IRB/Ethics board approval is obtained from Marmara University Ethical Board. Each principal investigator at each individual study site will be required to obtain IRB/Ethics board approval from his/her own institution. 2. Study population The adult patients (age >18 years) who are admitted to the emergency department with a clinical picture compatible with acute coronary syndrome will be screened for enrollment into the study. patients with an ECG or clinical (see below) diagnosis of acute myocardial infarction will be enrolled into the study. An ECG will be acquired as soon as possible in all screened patients and serial ECGs will be taken if the first one is not diagnostic. The ECGs will be scanned and digitized via an artificial intelligence (AI)-powered mobile phone application. If the patient gets a STEMI or OMI diagnosis by the ECG or clinical gestalt (refractory pain, hemodynamic instability, arrhythmia, cardiac arrest) they will be included in the study even if the later troponin results turn negative. If the ECG is not diagnostic for OMI or STEMI, a myocardial infarction diagnosis with a positive troponin will be necessary for the inclusion in the study. According to 4th universal definition of MI, the term acute MI will be used when there is acute myocardial injury (detection of a rise and/or fall of cTn values with at least one value above the 99th percentile upper range limit) with at least one of the following clinical indicators of acute myocardial ischemia: - Symptoms of myocardial ischemia; - New ischemic ECG changes; - Development of pathological Q waves; - Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischemic etiology; - Identification of a coronary thrombus by angiography or autopsy; - Post-mortem demonstration of acute atherothrombosis in the artery supplying the infarcted myocardium. All non-procedure related (excluding type 4a and 5 MIs), including type 1 (MI caused by atherothrombotic coronary artery disease which is usually precipitated by atherosclerotic plaque disruption (rupture or erosion)), type 2 (evidence of an imbalance between myocardial oxygen supply and demand unrelated to acute atherothrombosis), type 3 (cardiac death in patients with symptoms suggestive of myocardial ischemia and presumed new ischemic ECG changes before cTn values become available or abnormal) and type 4b and c (stent/scaffold thrombosis ore restenosis associated with percutaneous coronary intervention) will be included in the study. Patients with myocardial injury (either acute, as in acute heart failure or myocarditis, or chronic, as in chronic kidney disease or stable increased troponin levels with structural heart disease) without ischemia (abovementioned following clinical indicators of acute myocardial ischemia) will be excluded from the study. Randomization The patients will be randomized to the current STEMI/NSTEMI versus OMI/NOMI approaches using a cluster randomized trial design. Although the STEMI/NSTEMI approach is the current norm (a diagnosis of STEMI requires emergent catheterization, whereas the patients with NSTEMI are stabilized first and then electively undergo catheterization unless there are high-risk features), it would be unethical for a ECG reviewer, who is trained in recognizing the signs of ACO not fulfilling the current STEMI criteria, to suspend emergent reperfusion therapy after an OMI diagnosis has been made. Therefore, the ECG interpreters who are trained in OMI diagnosis cannot be randomized to STEMI/NSTEMI versus OMI/NOMI approaches. Hence, the groups will be randomized in the following fashion: In each center, a STEMI/NSTEMI and an OMI/NOMI intervention group will be formed. After these two groups are formed, the patients will be block-randomized into STEMI/NSTEMI and will be screened for enrollment into the study. patients with an ECG or clinical&#xd; (see below) diagnosis of acute myocardial infarction will be enrolled into the&#xd; study.&#xd; &#xd; An ECG will be acquired as soon as possible in all screened patients and serial ECGs&#xd; will be taken if the first one is not diagnostic. The ECGs will be scanned and&#xd; digitized via an artificial intelligence (AI)-powered mobile phone application. If&#xd; the patient gets a STEMI or OMI diagnosis by the ECG or clinical gestalt (refractory&#xd; pain, hemodynamic instability, arrhythmia, cardiac arrest) they will be included in&#xd; the study even if the later troponin results turn negative. If the ECG is not&#xd; diagnostic for OMI or STEMI, a myocardial infarction diagnosis with a positive&#xd; troponin will be necessary for the inclusion in the study. According to 4th&#xd; universal definition of MI, the term acute MI will be used when there is acute&#xd; myocardial injury (detection of a rise and/or fall of cTn values with at least one&#xd; value above the 99th percentile upper range limit) with at least one of the&#xd; following clinical indicators of acute myocardial ischemia:&#xd; &#xd; - Symptoms of myocardial ischemia;&#xd; &#xd; - New ischemic ECG changes;&#xd; &#xd; - Development of pathological Q waves;&#xd; &#xd; - Imaging evidence of new loss of viable myocardium or new regional wall motion&#xd; abnormality in a pattern consistent with an ischemic etiology;&#xd; &#xd; - Identification of a coronary thrombus by angiography or autopsy;&#xd; &#xd; - Post-mortem demonstration of acute atherothrombosis in the artery supplying the&#xd; infarcted myocardium.&#xd; &#xd; All non-procedure related (excluding type 4a and 5 MIs), including type 1 (MI caused&#xd; by atherothrombotic coronary artery disease which is usually precipitated by&#xd; atherosclerotic plaque disruption (rupture or erosion)), type 2 (evidence of an&#xd; imbalance between myocardial oxygen supply and demand unrelated to acute&#xd; atherothrombosis), type 3 (cardiac death in patients with symptoms suggestive of&#xd; myocardial ischemia and presumed new ischemic ECG changes before cTn values become&#xd; available or abnormal) and type 4b and c (stent/scaffold thrombosis ore restenosis&#xd; associated with percutaneous coronary intervention) will be included in the study.&#xd; Patients with myocardial injury (either acute, as in acute heart failure or&#xd; myocarditis, or chronic, as in chronic kidney disease or stable increased troponin&#xd; levels with structural heart disease) without ischemia (abovementioned following&#xd; clinical indicators of acute myocardial ischemia) will be excluded from the study.&#xd; &#xd; Randomization The patients will be randomized to the current STEMI/NSTEMI versus&#xd; OMI/NOMI approaches using a cluster randomized trial design. Although the&#xd; STEMI/NSTEMI approach is the current norm (a diagnosis of STEMI requires emergent&#xd; catheterization, whereas the patients with NSTEMI are stabilized first and then&#xd; electively undergo catheterization unless there are high-risk features), it would be&#xd; unethical for a ECG reviewer, who is trained in recognizing the signs of ACO not&#xd; fulfilling the current STEMI criteria, to suspend emergent reperfusion therapy after&#xd; an OMI diagnosis has been made. Therefore, the ECG interpreters who are trained in&#xd; OMI diagnosis cannot be randomized to STEMI/NSTEMI versus OMI/NOMI approaches.&#xd; Hence, the groups will be randomized in the following fashion: In each center, a&#xd; STEMI/NSTEMI and an OMI/NOMI intervention group will be formed. After these two&#xd; groups are formed, the patients will be block-randomized into STEMI/NSTEMI and&#xd; OMI/NOMI cohorts according to the team on-duty, i.e., the approach that center will follow on a certain day will be defined by the team on duty. The interventional cardiologists in both groups will be ensured to have a similar experience level (in terms of years of training, and angiography and primary PCI counts in the past year). All possible first responders in the network of a study center (who contact the patient first, according to the center this can be either a referring physician, an emergency physician or a cardiologist) will be provided with an AI-powered application for ECG diagnosis. These responders will receive diagnostic prompts from the application according to the center's on-duty team. If an OMI team member is on duty, the ECG interpretation will be OMI or not-OMI. If a STEMI team member is on-duty, the ECG interpretation will be disabled and will read "follow standard care". The first responder will thus elect to go for catheterization based on this approach and, whether that is by OMI or STEMI paradigm, the patient will be enrolled accordingly and the reason for proceeding to the catheterization laboratory will be written on the study form (or electronic sheet on the dedicated website). In the STEMI/NSTEMI arm, the contributors will blindly continue their usual practice, the ECG interpretation and decision to activate the catheterization laboratory will be done as usual. The STEMI/NSTEMI group will use the following criteria for the diagnosis of STEMI: (1) New ST-segment elevation at the J-point in two contiguous leads with the cut-point: ≥ 1 mm in all leads other than leads V2-V3 where the following cut-points apply: ≥2 mm in men ≥40 years; ≥2.5 mm in men <40 years, or ≥1.5 mm in women regardless of age, and (2) a peak troponin level above 99th percentile with a characteristic rapid rise and fall (retrospectively) and (3) a clinical picture compatible with acute coronary syndrome. If the decision to proceed to the cath lab was done only with the first criterion, the participant will remain in the study, even if the second criterion is not met. The patients meeting only criteria (2) and (3) will be classified as NSTEMI. On OMI/NOMI days, physicians are encouraged to actively search for ACO, regardless of whether STEMI criteria are present on the initial ECG. A diagnosis of OMI can be based on clinical gestalt, ECG findings, and adjunct modalities. Clinical gestalt includes hallmark presentations such as almost pathognomonic chest pain, and ischemic arrhythmias, hemodynamic instability, or cardiac arrest following typical symptoms. ECG diagnosis, whether interpreted by physicians or aided by an AI-powered smartphone application, incorporates static or serial changes for ACO using the DIFOCCULT-1 study algorithm. On OMI/NOMI days, the smartphone application is activated and available to all first responders associated with this center. This application assists diagnosis, but the final decision is left to the interventionalist on duty. Adjunct modalities include bedside echocardiography demonstrating new or presumed new wall motion abnormalities in patients with ongoing or recurrent chest pain, and significantly elevated initial troponin levels. For high-sensitive cardiac troponin (hs-cTn) T, it has been shown that a level exceeding 1000 ng.mL-1 is highly specific for major epicardial coronary artery occlusion. Similarly, a hs-cTn I >200 times the upper limit of normal (e.g., Architect, Abbott Diagnostics, Illinois, USA: 5000 ng/L; ADVIA Centaur, Siemens Healthcare, Tarrytown, USA: 5000 ng/L; Access, Beckman Coulter, Brea, USA: 2400 ng/L) is defined as a marker for OMI in patients with ongoing or fluctuating chest pain. In patients diagnosed with OMI, immediate catheterization laboratory activation with the intent to perform PCI is pursued. In NOMI patients, initial medical stabilization is prioritized, followed by elective catheterization per the NSTEMI pathway unless high-risk features are identified. STEMI and OMI patients (will be taken as STEMI equivalents for therapeutic purposes) will be managed according to the current STEMI guidelines, whereas NSTEMI and NOMI patients are managed according to the current NSTEMI guidelines. A separate diagnostic group with 'probable OMI' and 'high-risk STEMI' is also allowed for patients who do not fulfil STEMI/OMI criteria but need urgent catheterization for other high-risk features or high clinical suspicion for having an ACO. These patients will also be managed according to the current guidelines. However, patients will be excluded from analysis if their early catheterization is based solely on social or logistical considerations, and not based on the medical need. For example, a patient would be excluded if he/she is brought to the cath lab early based on the immediate availability of cath lab or because the patient is already scheduled for elective coronary angiography. The patients who have alternative diagnoses (myocarditis, pericarditis, pulmonary embolism etc.) but were not included due to a clinical or ECG diagnosis of STEMI/NSTEMI or OMI/NOMI will be excluded from the study. Similarly, the patients without a characteristic troponin kinetics who were not included due to a clinical or ECG diagnosis of STEMI/NSTEMI or OMI/NOMI will be excluded from the study. Endpoints The primary composite endpoint is all-cause mortality and all-cause re-hospitalization during follow-up across the entire cohort. The study places equal emphasis on a predefined evaluation of the OMI (+) NSTEMI. The secondary comparisons will be done for the presence of ACO on angiogram, false positive catheterization laboratory activation rate, the infarct size as defined by 24-72 hour peak troponin, wall motion score index (WMSI), left ventricular ejection fraction (LVEF), in-hospital CPR, intubation and mortality. These will be analyzed both with intention to treat and per protocol approaches. To define this subgroup in the OMI/NOMI arm, all ECGs diagnosed as OMI during the study will be randomly assigned to researchers in the STEMI/NSTEMI arm after study completion. The researchers will then assess whether the ECG is compatible with STEMI or NSTEMI. Patients diagnosed as NSTEMI within the OMI group will be classified as the OMI (+) NSTEMI subgroup in the OMI/NOMI arm. In the STEMI/NSTEMI arm, patients diagnosed with NSTEMI will have their ECGs scanned and interpreted by the AI-powered application. If the ECG is interpreted as OMI, these patients will be included in the OMI (+) NSTEMI subgroup within the STEMI/NSTEMI arm. The OMI diagnosis also includes clinical variables, such as clinical gestalt and very high first troponin levels. However, clinical gestalt cannot be acted upon retrospectively (e.g., bedside echocardiography or serial ECGs). Nevertheless, if a patient is recorded with ongoing chest pain and a very high first troponin level (based on center-specific and troponin kit-specific values), this will be included in the OMI (+) NSTEMI subgroup in the STEMI/NSTEMI arm, even if the ECG is not interpreted as OMI by the AI-powered application. The primary source of outcome data will be the Turkish national electronic database (e-nabız), which provides comprehensive, real-time updates on all deaths and hospitalizations nationwide. To ensure the completeness and accuracy of data, direct phone contact with participants or their families will be conducted as a secondary measure. All collected outcomes will be reviewed by an independent outcome adjudication board blinded to the study arms. Estimated number of subjects to be submitted: For the overall cohort, we estimated that enrolling 3,185 participants would provide 95% statistical power to detect a hazard ratio (HR) of 0.87, corresponding to a 13% relative risk reduction in the combined primary endpoint for the OMI/NOMI approach compared to the STEMI/NSTEMI approach. To account for the hierarchical nature of our study design and the structured nature of PCI-based STEMI/NSTEMI treatment pathways, we selected an intra-cluster correlation coefficient of 0.015 and an average cluster size of 50 patients per interventionalist team. Applying a design effect correction of 1.74, this adjustment increased our required sample size from 3,185 to 5,526 participants. To maintain feasibility and account for potential dropouts, the final target enrollment was rounded to 6,000 patients. For the OMI (+) NSTEMI subgroup analysis, this sample size was also sufficient. This sample size is also expected to provide sufficient power to detect at least a 10% relative improvement in infarct size, left ventricular ejection fraction, and wall-motion score index among STEMI (-) OMI (+) patients undergoing early revascularization in the OMI arm compared to those receiving standard-timing revascularization in the STEMI/NSTEMI arm, assuming a 30% OMI prevalence in the NSTEMI cohort and for a ROC comparison. 3. Participating centers Listed elsewhere. 4. Data Collection From September 1, 2024, AI-powered ECG App will be distributed to the referring hospitals by the participating centers. The study will start at all participating centers on October 1, 2024. A dedicated website (difoccult.org) will be used for data entry and storage. Study data is collected and managed using REDCap (Research Electronic Data Capture) tool hosted at a dedicated server. REDCap is a secure, web-based software platform designed to support data capture for research studies, providing (1) an intuitive interface for validated data capture; (2) audit trails for tracking data manipulation and export procedures; (3) automated export procedures for seamless data downloads to common statistical packages; and (4) procedures for data integration and interoperability with external sources. A data monitoring board ensures the completeness, integrity, and accuracy of the entries, providing feedback to the data entry team and requesting explanations or modifications as needed. Baseline variables Collected baseline variables and their definitions are listed in the REDCap printout in the supplemental file. Electrocardiogram ECGs will be acquired using standard conventions. If the first ECG is non-diagnostic, serial ECGs will be acquired every 15 minutes for an hour and the first diagnostic ECG will be used in the analyses. If all of them are non-diagnostic the physician may still use additional tools such as the clinical picture, bedside echocardiogram, troponin results to diagnose 'high-risk NSTEMI' or 'possible OMI'. All pre-intervention ECGs and at least one pre-discharge ECG will be uploaded to a central cloud database to be retrospectively reviewed by core lab investigators. The absence of a technically adequate pre-cath ECG will be a reason for the exclusion of the participant. If ECG diagnosis is not compatible with the inclusion criteria for the assigned group, this will be noted and the patient will be excluded from the per-protocol analyses. Following coding will be used for ECGs: Type 1 EGGs: New ST-segment elevation at the J-point in two contiguous leads with the cut-point: ≥ 1 mm in all leads other than leads V2-V3 where the following cut-points apply: ≥ 2mm in men ≥ 40 years; ≥ 2.5 mm in men < 40 years, or ≥ 1.5 mm in women regardless of age. Type 1a: The amplitude, morphology, extent of STE and the presence of additional findings (hyperacute T waves, Q-waves, terminal QRS distortion) make ECG highly obvious for MI presumably due to acute, thrombotic occlusion. These ECGs will be included in both STEMI and OMI definitions. Type 1b: There is ST-segment elevation that meets criteria for STEMI, but it is uncertain whether it is due to MI or to another condition, such as benign variant STE, left ventricular hypertrophy, left bundle branch block, prior MI, pericarditis, etc. These ECGs will be included in the STEMI definition but not in the OMI definition, unless there are additional findings suspicious for acute coronary occlusion as follows: Differential diagnosis for benign variant STE: Type 1b, if fulfills STEMI criteria. But re-classified as Type 2b, if the Aslanger/Smith formula is positive. Aslanger's formula: (R-wave amplitude in lead V4 + QRS amplitude in V2) - (QT interval in millimeters + STE60 in V3) <12 (Aslanger E Am J Cardiol, 2018). Differential diagnosis for left ventricular hypertrophy: Type 1b unless ST segment to R-S-wave magnitude is equal or greater than 15% (then indicates OMI, Type 2b) (Armstrong EJ et al. Am J Cardiol, 2012, Aslanger et al. Arch Turk Soc Cardiol, 2021). Differential diagnosis for isolated left bundle branch block: Will be coded as Type 1b, unless one of the modified Sgarbossa criteria is positive (then indicates OMI, Type 2b): ≥ 1 lead with ≥1 mm of concordant ST elevation, ≥ 1 lead of V1-V3 with ≥ 1 mm of concordant ST depression, ≥ 1 lead anywhere with ≥ 1 mm STE and proportionally excessive discordant STE, as defined by ≥ 25% of the depth of the preceding S-wave (Smith SW et al. Ann Emerg Med 2012). Differential diagnosis for prior MI: Type 1b, unless Smith's rule is positive (then indicates OMI, Type 2b): Smith's rule: If any 1 lead between V1-V4 has a T-wave amplitude to QRS amplitude ratio greater than or equal to 0.36 (Klein LR et al. Am J Emerg Med 2015). Differential diagnosis for pericarditis: Type 1b, unless there is ST-depression in aVL (then indicates OMI, Type 2b) (Bischof JE et al. Am J Emerg Med. 2016). Type 1c: There is ST-segment elevation that meets criteria for STEMI, but there is also T-wave inversion and pathologic Q waves indicative of subacute MI. These ECGs will be excluded from per-protocol analyses, since these patients have ACO on angiogram and higher long-term mortality but gain little, if not any, benefit from reperfusion with both approaches. Patients with preserved QRS complexes (Wellens' pattern) will be included in type 2c ECGs. Type 2 EGGs: ECG that meets acute myocardial ischemia criteria recommended by fourth universal definition of MI. Type 2a: The ECG has "primary'', i.e. cannot be completely explained as secondary to a depolarization disorder, ST-segment depression or T-wave inversion that is nondiagnostic of STEMI but is diagnostic of myocardial ischemia. Type 2b: Does not meet recommended criteria for STEMI, but highly suggestive for ACO, despite being subtle and difficult. Possible findings are minor STE with or without minor reciprocal ST-depression not fulfilling STEMI criteria, hyperacute T-waves or DeWinter's pattern, subtle anterior STE hard to differentiate from benign variant STE and nonconsecutive STE. These ECGs will be included in the OMI definition but not in the STEMI definition. The detailed algorithm defined in the DIFOCCULT trial (Aslanger et al. In J Cardiol Heart Vasc, 2020; Aslanger et al. J Electrocardiol, 2021; Aslanger et al. Arch Turk Soc Cardiol, 2021) will be used for recognizing these ECGs. Type 2c: Patients with preserved QRS complexes (Wellens' pattern), with or without some STE, but with significant T wave negativity will be included in type 2c ECGs. These ECGs will be excluded from per-protocol analyses, since these patients may not gain benefit from emergent reperfusion in both approaches. Type 3 ECGs: Nonspecific ECG that is abnormal but nondiagnostic of any kind of acute coronary syndrome. Minor abnormalities including left ventricular hypertrophy without ST-T changes, arrhythmias, impulse generation and conduction diseases etc. Type 4 ECGs: Completely normal ECG. AI-Powered ECG Application In OMI/NOMI arm ECGs can be digitized and interpreted by AI-powered ECG application prospectively. In STEMI/NSTEMI arm, interpretation will be done retrospectively. The application's functionality varied based on the study arm determined by the team on duty. On OMI/NOMI days, the AI application is fully activated and accessible to all first responders associated with that center. When a user captures a photo of an ECG, the application digitalizes the image, interprets the data, and displays one of two messages: "OMI" or "Not-OMI." First responders were instructed to promptly inform the interventionalist on duty for potential catheterization laboratory activation if result shows "OMI". On STEMI/NSTEMI days, the AI-supported application is deactivated for that center. If a first responder attempts to capture a photo of an ECG, a warning message is displayed: "We are now following the standard STEMI/NSTEMI approach. Please continue your usual practice." A commercial version of the same smartphone application by the same company is also available on the market. During the study, if a network address is detected accessing both the commercial and study-specific applications, the commercial version is deactivated by the company, and a notification mail is sent explaining that the commercial smartphone application will not be available to users in Türkiye for the duration of the study. Additionally, all ECGs stored in the study database will be cross-referenced with the commercial smartphone application's ECG history. If any matches are identified, the corresponding patient will be excluded from the study. After the study completion, ECGs in both study arms will be reviewed and coded as defined above for intention-to-treat and per-protocol analyses. This will be done by two separate ECG interpreter. Should there be any discrepancy between these interpreters, a third interpreter (from data monitoring board) will be consulted. Type 1a, 1b and 1c ECGs will be deemed as compatible with STEMI. Type 1a, 2b and 2c ECGs will be deemed compatible with OMI diagnosis. Troponins The troponin levels will be measured at admission, hourly if needed for the diagnosis, every 6 hours until it peaks after an MI diagnosis is made, and then daily. The 24-72 hour peak troponin level (usually 48h) will be used as a surrogate for infarct size. Angiograms Coronary angiography will be undertaken according to the standard conventions. Each angiogram will be reviewed by two interventionalist. Should there be any discrepancy between these interpreters, a third interpreter (from data monitoring board) will be consulted. Following points will be noted for the presence of an ACO: (1) the Thrombolysis in Myocardial Infarction Study (TIMI) flow level in the infarct-related vessel. The presence of well-developed collaterals to the distal vessel, appearance of the total occlusion, easiness of guidewire crossing will also be assessed to determine if the total occlusion is acute in nature. If necessary, the primary operator will also be contacted. (2) The presence of an acute lesion with definitive culprit features, which was defined based on several angiographic properties including critical stenosis, irregular lesion borders, presence of angiographic thrombus or staining. ACO Adjudication Because the infarct-related artery may spontaneously open by the time of the angiogram or total occlusion may be chronic in nature, a composite ACO using following criteria is defined: 1. An acute culprit lesion with TIMI 0-2 flow PLUS a peak troponin level equal to or greater 5 than five times the ULN PLUS at least 20% rise within the first 24 hours 2. A highly elevated peak (for troponin T>1000 ng/mL and for troponin I 200 times of the average of ULN (known to be highly correlated with ACO)) without an obvious alternative diagnosis or with supporting evidence (ECG evolution, culprit-looking lesion on angiogram in a coronary territory compatible with ECG/echocardiographic area at concern) 3. cardiac arrest before any troponin rise has been documented with supporting clinical evidence of possible ACO. Follow-up The last participant in the study will be followed up to one year. The survival status and re-hospitalization will be checked from the national database and a phone call, if required. Statistical Analysis Baseline characteristics will be summarized using standard descriptive statistics. Comparisons of relevant parameters between groups will be performed by chi-square, Fisher's exact test, Mann-Whitney U, and student t-test, as appropriate. Patients with missing values will be excluded pairwise from analyses. A Cohen's κ test will be used for determination of the intra- and inter-observer agreement for ECG classifications and ACO adjudication. Kaplan-Meier analysis will be performed to determine the cumulative long-term mortality rates in different ECG subgroups. The mortality across groups will be compared using a log-rank test. A Cox-regression model will be used to perform a survival analysis according to basal GRACE risk score, intervention timing and treatment status. Baseline characteristics with a P value of 0.05 or less in the univariate analysis will be included and a step-down procedure will be applied for selection of final covariates. To address potential variability in outcomes due to interventionist or center-related factors, we will incorporate a random effects (frailty) term into the Cox model. The calibration cohort (the patients with type 1a ECGs and treat with the same manner in both arms) will be used to estimate variability attributable to interventionist practices. The random effect variance (σ2) calculated from this cohort will inform the frailty term in the full Cox model, ensuring that differences in outcomes due to interventionist-related variability are appropriately adjusted. The final model will include patient-level covariates, random effects for interventionists or centers, and calibration adjustments based on the calibration cohort. The sensitivity, specificity and diagnostic accuracy of STEMI/NSTEMI or OMI/NOMI ECG approaches will be calculated using receiver operating characteristics analysis. As these parameters are highly dependent on the pre-test probability of the disease and pre-test probability of ACO and long-term mortality are closely associated with the presentation type, the investigators will also repeat these analyses after weighing cases for the total number of hospital admissions in the study period. Statistical analyses will be performed with SPSS (version 24.0; SPSS Inc., Chicago, IL) and MedCalc Software (version 18.2.1 [Evaluation version]; MedCalc Software, Ostend, Belgium). 5. Safety monitoring and reporting Study REDCap forms necessitate in-hospital adverse events to be actively collected to monitor and report any in-hospital adverse events. An independent Data Safety Monitoring Board (DSMB) has been established to oversee the safety and progress of the trial. The DSMB convened via teleconference during the pretrial period, upon enrollment of 20% of the participant sample size, and will continue to meet after each subsequent 20% enrollment milestone. The primary objective of the DSMB is to monitor enrollment milestones and the safety of the interventions. A four-point combined safety endpoint will be closely monitored: (1) myocardial infarction size by 48.hour troponin, ejection fraction and wall motion score index; (2) integrity of coronary intervention by in-hospital stent thrombosis; (3) integrity of in-hospital care by in-hospital intubation, in-hospital cardiopulmonary resuscitation and in-hospital mortality and (4) long-term therapy by discharge treatment. If a statistically significant increase in this four-point combined safety endpoint is observed in either of the study arms after the enrollment of any 20% of the participant sample size, the DSMB will make a recommendation regarding the revision, rearrangement or potential exclusion of the study participants or the study center. 6. Study integrity The study is an investigator-initiated trial conducted under the auspices of the Turkish Society of Cardiology. The Turkish Society of Cardiology supports the investigator team in developing the trial design and organizing the participating centers. The steering committee oversees the processes of recruitment, consent and assent, follow-up, and ensures the validity and integrity of data acquisition. The trial has been approved by the Ethical Board of Marmara University (09.2021.523), any change in protocol or centers will be addressed by this board. The study will be conducted in accordance with Good Clinical Practice guidelines.

Effectiveness of Smoking Cessation Education

Smoking is a significant psychosocial issue that affects society. The substance responsible for smoking addiction is nicotine, which has a stronger addictive potential than other psychoactive substances. Tobacco, in addition to its many physical health risks, is also a psychoactive substance that can lead to mental and behavioral disorders. It is estimated that 1.3 billion people worldwide use tobacco products, and approximately 8 million people die each year due to smoking. Despite the high mortality rate, smoking addiction is considered one of the leading preventable causes of disease and death. Individuals with mental health disorders have significantly higher smoking rates compared to the general population. Studies indicate that people diagnosed with schizophrenia, bipolar disorder, and major depression smoke at a rate three to four times higher than the general public. This high smoking prevalence among individuals with severe mental illness is associated with increased morbidity, mortality, and higher healthcare costs. Reducing the burden of physical illness among people with mental disorders is recognized as a national priority, making smoking cessation among these individuals particularly important. Nurses, who form the largest group among healthcare professionals and spend the most time with patients, play a crucial role in smoking cessation efforts. Nurses are expected to be actively involved in smoking prevention and cessation. International health authorities emphasize the need for nurses to be at the forefront of tobacco control efforts. Global smoking cessation campaigns primarily target healthy individuals as part of preventive health strategies. However, special groups such as psychiatric patients should also be included in smoking cessation initiatives. Research indicates that a significant proportion of individuals with mental illness who smoke express a desire to quit. Furthermore, interventions that enhance smoking cessation success among the general population are also effective for individuals with mental health disorders. It is strongly recommended that evidence-based smoking cessation interventions be applied to individuals with mental disorders, just as they are to the general population. Given the high prevalence of nicotine addiction among individuals with mental disorders and the preventable nature of smoking-related deaths, the importance of smoking cessation initiatives becomes evident. However, research has shown that mental health teams do not consistently implement evidence-based smoking cessation interventions. Although literature highlights the severity of smoking issues among individuals with severe mental illness, studies on smoking cessation interventions remain limited. Notably, randomized controlled trials examining the effectiveness of nurse-led smoking cessation interventions for this population are scarce. This study aims to evaluate the effectiveness of smoking cessation education among patients registered at community mental health centers. It is expected to contribute to reducing smoking addiction, which is prevalent among individuals with mental disorders, while also raising awareness among mental health professionals, particularly nurses, about the importance of smoking cessation efforts.

Effect of Genetic Polymorphisms on Response to Preoperative NSAIDs in Endodontic Postoperative Pain Management

Effect of FAST HUGS WITH ICU Approach on Length of Intensive Care Unit Stay in Patients With Hypoxic Respiratory Failure

Hypoxic respiratory failure is responsible for 1.9 million patient admissions per year in the United States alone, and the hospital mortality rate is as high as 20%. This rate is also increasing in Turkey. The most common causes include pneumonia, cardiogenic pulmonary edema, ARDS, and chronic obstructive pulmonary disease (COPD). Fast hugs is important in affecting the prognosis of patients with hypoxic respiratory failure in special clinics such as the Chest Diseases Intensive Care Unit. Therefore, new studies are needed. This study will investigate the effect of the FAST HUGS WITH ICU approach on the length of stay in the intensive care unit in patients with hypoxic respiratory failure. Patients will be randomly assigned to the experimental and control groups. The standard procedure will be applied to the control group. The FAST HUGS WITH ICU approach will be applied to the experimental group. We plan to follow up patients with Hypoxic Respiratory Failure using the abbreviation FAST HUGS WITH ICU (Feeding, Analgesia, Sedation, Thromboembolic prophylaxis, Head of bed elevation, Stress Ulcer prophylaxis and Glucose control Spontaneous breathing trial, Water Balance and constipation, Investigation and results, Therapy, Hypo-hyper delirium, Invasive devices, Check the daily infection parameters, Use a checlist). The two groups will be examined in terms of hospital stay and some blood gas parameters.

Effectiveness of Motivational Interviewing in Patients With COPD

Nursing, which arises from human needs, evaluates the individual, family, and society with a holistic perspective to protect, maintain, and improve the health of healthy/sick individuals, families, and communities, and provides the necessary health services. The primary duty of nurses is to provide care for individuals and improve their quality of life. In this regard, nurses fulfill their duties by using their roles such as counselor, educator, decision-maker, manager, researcher, and caregiver. Nurses have significant responsibilities in the care of chronic diseases that require lifelong care and follow-up. One of the major chronic diseases requiring lifelong care is Chronic Obstructive Pulmonary Disease (COPD). COPD is a progressive, irreversible disease characterized by airflow obstruction, accompanied by various symptoms, and is a serious health problem with high mortality and morbidity, commonly encountered worldwide. Approximately 3.2 million people die annually from COPD globally, and it is projected that this disease will be the third leading cause of death worldwide by 2030. COPD patients experience many physical and psychological issues that severely affect their quality of life, such as fear of death, anxiety, cough, dyspnea, fatigue, and loss of appetite . COPD patients are frequently hospitalized, face difficulties in performing daily activities, encounter social and economic losses, and experience a significant decline in quality of life due to the side effects of medications. Among the long-term management goals of disease control are the reduction of current symptoms and future risks. These goals require patients to exhibit healthy behaviors. However, the literature reports that COPD patients have low levels of self-care, poor adherence to medications, and a lack of awareness regarding preventable and behavioral causal factors. COPD patients need strategies that will engage them in the treatment process, motivate them toward healthy habits, and help internalize healthy behaviors. Compared to other strategies, motivational interviewing (MI) embodies most of these qualities. MI is defined as "collaborative, person-centered form of guiding and counseling to elicit and strengthen motivation for change". The MI technique is a distinctive and superior approach to other interview methods due to its effectiveness in helping individuals make behavioral changes, its empathetic and collaborative approach, its ability to increase intrinsic motivation, and its strategies for dealing with resistance. MI aims to promote change by increasing the patients intrinsic motivation, making it especially effective for patients with more specific change goals. The use of nursing models in the care of COPD patients has been associated with better patient outcomes, higher nurse satisfaction, and lower healthcare costs. Pender's Health Promotion Model (HPM) provides nurses with a comprehensive framework for conducting effective care and assessing individuals perceptions of health behaviors. The model assumes that individuals have a holistic structure in their physical environment and interpersonal relationships and play an active role in maintaining and promoting their health. The goal of the model is to explain the components of behaviors necessary for a healthy lifestyle, evaluate individuals experiences, analyze factors that may affect their perceptions of health behavior, and guide care providers in planning healthy lifestyle goals. In light of this information, it is recognized that MI and HPM share common goals and possess complementary dynamics. Addressing lifestyle changes with Pender&amp;#39;s model and integrating MI for health promotion has been reported to be more effective in managing COPD patients symptoms. Dişsiz and Çalışkan also suggest that nurses can use HPM and MI, which are thought to complement each other, while helping patients acquire healthy lifestyle behaviors. Patient-reported outcomes are necessary to assess the symptoms, the impact of symptoms on their lives, and their response to treatment. Patient-reported outcomes provide direct reports of patients perceived health statuses. While the primary role of nurses is caregiving, they should also engage in roles such as educator, therapist, counselor, and researcher to implement interventions that improve the care of COPD patients. Nurses should support individuals to use their potential strengths and help them adopt health behaviors through health promotion programs. MI and the Health Promotion Model have been shown to be effective strategies and models in facilitating health behavior change. Based on this information, this research was conducted to determine the effect of motivational interviewing based on Pender's Health Promotion Model on patient-reported outcomes in COPD patients.

Predicting Bone Cement Implantation Syndrome Using Artificial Intelligence Methods

Since the prevalence of hip and knee osteoarthritis increases with age, orthopedic prosthesis operations are widely performed all over the world and in our country. In these surgeries, bone cement is used to ensure adhesion of the prosthesis to the bone. Bone cement implantation syndrome (BCIS) is a fatal complication of cemented bone surgery characterized by systemic hypotension, pulmonary hypertension, arrhythmias, loss of consciousness and cardiac arrest, most commonly occurring during cementing and prosthesis placement, and is increasingly being reported. The syndrome is most commonly seen in cemented hemiarthroplasty after displaced femoral neck fractures, but also occurs in total hip and knee replacement surgery. Despite the publication of safety guidelines to reduce BCIS, it remains a common intraoperative complication with an overall incidence of up to 28% and is a major cause of intraoperative and postoperative morbidity and mortality. The pathophysiology of BCIS is unclear, including hemodynamic instability as a result of changes in pulmonary and systemic vascular resistance, increased intramedullary pressure resulting in the incorporation of polymethyl methacrylate monomers into the circulation causing vasodilation, release of mediators from polymethyl methacrylate, release of fatty acids, and release of mediators from polymethyl methacrylate, Acute right ventricular failure, anaphylaxis, inflammatory and exothermic reaction, and complement activation may include one or a combination of acute right ventricular failure, anaphylaxis, inflammatory and exothermic reaction, and complement activation, which develops when cement and clot particles cause emboli in many organs in the body, especially in the pulmonary system, with increased pulmonary vascular resistance. Donaldson et al. developed a classification system for BCIS severity. Grade 0: no hypotension/hypoxia; Grade 1 moderate hypoxia (SpO2 < 94%) or hypotension [systolic blood pressure (SBP) > 20% decrease from baseline]; Grade 2 severe hypoxia (SpO2 < 88%) or hypotension (SBP > 40% decrease from baseline) or unexpected loss of consciousness; Grade 3 cardiovascular collapse requiring cardiopulmonary resuscitation. Patients with BCIS grades 2 and 3 have been shown to have a 16-fold increase in 30-day postoperative mortality compared to those with BCIS grade 1. Most reports on BCIS focus on deaths and serious problems, and most cases of mild BCIS go unreported. Suspected BCIS should be treated with aggressive resuscitation and supportive care. This risk may prompt some surgeons not to use cement in arthroplasty operations. Although cementless hemiarthroplasty eliminates this risk and saves an average operating time of 20 minutes, it is associated with serious complications. Patients undergoing uncemented hip arthroplasty implants are more likely to experience periprosthetic fractures as well as early revision. Uncemented arthroplasty has a 17-fold greater risk of periprosthetic fracture revision or aseptic revision due to loosening compared to cemented hip arthroplasty. Since additional surgery carries an additional risk of death, skipping the cementation step may also not be the best choice in these patients who are more likely to fall and undergo revision surgery. Early detection of this complication and early intervention is crucial as it will reduce mortality. Prevention of BCIS includes identification of high-risk patients, preoperative optimization of patient risk factors and comorbidities, and good communication with the surgical team. In this way, the patient's comfort and life expectancy can be increased. The increasing number of patients needing and waiting for arthroplasty makes it difficult to identify high-risk patients, optimize patient risk factors and comorbidities preoperatively to prevent this potentially fatal complication. The condition in which BCIS may occur is evaluated according to the results of analyzing the data obtained from retrospective and prospective data sets with complex biostatistical methods. In order to predict the complication, predictive factors associated with it are tried to be determined. Spann et al. (2020) stated in their review study that machine learning can be used in analyzes beyond complex biostatistical methods. At this point, a decision support system created with artificial intelligence modeling will help in the early detection of this complication and thus serve as an important decision-support mechanism for clinicians by increasing the patient's comfort and life expectancy. However, it is not easy to assess at what level this complication will be predicted and reduced without implementing the system.

A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer

The purpose of this study is to assess the efficacy and safety of rilvegostomig in combination with fluoropyrimidine and T-DXd (Arm A) compared to trastuzumab, chemotherapy, and pembrolizumab (Arm B) in HER2-positive locally advanced or metastatic gastric or GEJ adenocarcinoma participants whose tumors express PD L1 CPS ≥ 1. Rilvegostomig in combination with trastuzumab and chemotherapy will be evaluated in a separate arm (Arm C) to assess the contribution of each component in the experimental arm. This study will be conducted at up to 200-250 sites globally in approximately 25 countries.

Comparison of Oxygenation Index and Oxygen Stretch Index

Pediatric acute respiratory distress syndrome (pARDS) is a heterogeneous clinical syndrome that causes high rates of mortality and morbidity. The Pediatric Acute Lung Injury Consensus Conference (PALICC) guideline recommends using the oxygenation index (OI = mean airway pressure (MAP) × FiO2 /PaO2) for the diagnosis and classification of pediatric ARDS. In recent years, studies conducted on adult and pediatric populations have emphasized ''driving pressure'' as the most important ventilator parameter associated with mortality. Driving pressure (DP) is calculated by subtracting PEEP from plateau pressure. It is an important determinant of tidal volume in each breath and indirectly reflects lung stress. Lung stress is directly measured with transpulmonary pressure (PL). Mechanical power (MP) is the amount of energy applied to patients per unit time and its relationship with lung injury has been shown in adult and pediatric studies. Another method that shows lung damage is measured noninvasively at the patient's bedside. It has been validated in many adult, pediatric, and neonatal studies. In an adult study, DP was used instead of MAP inspired by the oxygenation index and defined as the Oxygenation stretch index. It was emphasized that it can better predict oxygenation and mortality. OI is not used in the ARDS classification in adults. Adding airway pressure to the oxygenation equation is very important to standardize the severity of the disease. However, its effect on patient outcomes has not been determined as much as mean airway pressure, plateau, and driving pressure. In addition, no target recommendation has been presented in the PALICC guidelines. Plateau pressure is the end-inspiratory pressure and does not have a direct effect on PEEP. Since ventilator management is still heterogeneous in pediatric literature in line with the guidelines, it seems more logical to use driving pressure, which includes both inspiratory pressure and expiratory pressure. Within the framework of this information, adding driving pressure to the formula instead of Pmean (MAP) in the oxygenation index may be useful in evaluating both the severity of pARDS and the effectiveness of respiratory dynamics. In our study, we will compare the Oxygenation Stretch Index with OI in patients with pARDS. We will examine its effects on parameters indicating lung damage, respiratory mechanics and patient outcomes.

PVP-Guided Decongestive Therapy in HF 2

I. BACKGROUND AND SIGNIFICANCE Precise assessment of volume status is essential in diagnosis and management of diuretic therapy in patients hospitalized for heart failure (HF). Unfortunately, no clear guidelines are present for in-hospital management of congestion. Consequently, nearly half of the patients hospitalized for congestive HF are discharged with persistent congestion. This contributes to high rates of readmission and mortality. Recently, it has been shown that a simple assessment of peripheral venous pressure (PVP) demonstrates a high correlation with central venous pressure (CVP), indicating that PVP may be useful in the standard bedside clinical assessment of volume status in HF patients to help guiding decongestive therapy. II. THE HYPOTHESIS The main hypothesis is as follows: A simple assessment of peripheral venous pressure (PVP) will better guide the diuretic need and long-term outcomes (all-cause mortality, all cause re-hospitalization, emergency department visits) compared to standard evaluation. III. METHODS 1. Application for Institutional Review Board (IRB)/Ethics board approval The study will be at participating centers. An IRB/Ethics board approval has been obtained from Marmara University, Pendik Training and Research Hospital local ethics board. 2. Study population Patients 18-99 years old who were admitted with a de novo or decompensated chronic HF and accept to participate in the study will be enrolled. Patients will be included regardless of ejection fraction or etiology of HF, but these will be noted as baseline variables. All patients or legal surrogate decision makers will be requested to provide a written informed consent prior to enrollment. Patients who withdraw their consent, those with upper extremity venous pathology, those with a baseline creatinine level equal to or above 3.5 mg/dL, those with severe stenotic valvular disease and hypertrophic cardiomyopathy will be excluded. 3. Data Collection The study will start at participating centers on July 1, 2024. Baseline variables Baseline variables will be entered to the electronic study form (RedCap). Procedures A peripheral intravenous (IV) access, using an 18 to 22-gauge IV line, will be placed preferably to an upper extremity vein before enrollment. This line will be used to draw blood samples first. After blood samples were collected the subjects will be randomized to standard or PVP guided therapy groups. Randomization will be done using a computer-generated random allocation list via RedCap randomization module. The details of demographic characteristics, symptoms, physical examination findings and drug list will be noted to a standard electronic study form (see appendix). A routine electrocardiogram and echocardiogram will be performed at the earliest convenience. After the blood samples were collected, line will be flushed carefully. PVP will be obtained by transducing a peripheral intravenous line after zeroing at the phlebostatic axis. The phlebostatic axis will be accepted as the midpoint between the anterior and posterior surfaces of the chest at the level of the fourth intercostal space meets with sternum, which is assumed to be correlated with the mid-level of the right atrium. The patient's arm will be placed parallel to the patient such that the position of the peripheral IV to be at the phlebostatic axis. Continuity of the peripheral IV line with the central venous system will be confirmed by demonstrating augmentation of the venous pressure waveform using manual or tourniquet circumferential occlusion of the extremity proximal to the catheter and modified Valsalva maneuver. If the pressure waveform failed to augment appropriately, data will not be collected, and the patient will be documented for study purposes as a technique failure. Daily fluid intake and output, weight, and biochemistry measurements, as required, will be done. The patients in whom the first and the predischarge PVP cannot be measured due to technical issues (unable to provide upper extremity IV access, unable to confirm augmentation or Valsalva test) will be excluded from the study. Also, the patients requiring in-hospital intubation, high-dose inotrope or vasopressor infusion (≥10 mcg.kg-1.min-1 dopamine, dobutamine or equivalent), intraaortic balloon support, dialysis or veno-venous ultrafiltration will be excluded from the study (but these patients will be included in the in-hospital analyses). In hospital diuretic treatment will be guided by ESC guidelines (see references). In the standard therapy arm, the treatment and the decision of discharge will be left to physicians' discretion. In the PVP-guided arm, a PVP < 9 mmHg will be targeted before discharge. Outcomes The primary outcome of the study is the composite endpoint of all-cause mortality, all-cause hospitalization and all-cause emergency department visits. The secondary outcomes will include cardiovascular mortality, HF-related hospitalization, HF-related emergency department visits. This information on these outcomes will be obtained from the national electronic database. The follow-up duration is planned to be limited to one year. Predefined secondary analyses There will be subanalyses from the same cohort, as defined below: - The correlation between predischarge PVP and long-term outcomes. A multivariable analysis will also be executed for predicting the primary end point. - The correlation between the change in PVP during hospital stay and long-term outcomes. A multivariable analysis will also be executed for predicting the primary end point. - The correlation between the change in PVP during hospital stay and worsening renal function, renal injury, need for dialysis or veno-venous ultrafiltration. - The comparison of the two arms in terms of worsening renal function, need for dialysis or veno-venous ultrafiltration. - The comparison of the two arms in terms of EVEREST congestion score. - The comparison of the two arms in terms of the days in hospital. - The comparison of the two arms in terms of the number of repeat hospitalizations. - Usual patterns of diuretic use Estimated number of subjects to be submitted: We estimated that the enrollment of 621 participants would provide the study with a statistical power of 95% to detect a relative risk reduction of 26% (hazard ratio [HR] = 0.74) for the composite primary outcome (PVP-guided group: 40%, standard approach: 50%), using a two-sided test at the 0.05 significance level. This calculation assumes a 10% censoring rate and a 1-year follow-up period. The weighted event rate (πe=45%) was used to estimate the required number of events. To account for potential loss to follow-up and ensure robust analysis, the sample size was increased to 650 participants, maintaining equal allocation between groups (1:1 randomization). Statistical Analysis Baseline characteristics will be summarized using standard descriptive statistics. Comparisons of relevant parameters between groups will be performed by chi-square, Fisher's exact test, Mann-Whitney U and student t-test, as appropriate. Kaplan-Meier analysis will be performed to determine the cumulative long-term mortality and composite outcome rates in subgroups. The mortality across groups will be compared using log-rank test. A Cox-regression model will be used to perform a survival analysis according to pre-discharge peripheral venous pressure and composite outcome. Baseline characteristics with a P value of 0.05 or less in the univariate analysis will be included and a step-down procedure will be applied for selection of final covariates. Statistical analyses will be performed with SPSS (version 24.0; SPSS Inc., Chicago, IL) and MedCalc Software (version 18.2.1 [Evaluation version]; MedCalc Software, Ostend, Belgium).