Fukuyama-shi, Hiroshima, Japan

Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial

The DECLARE Trial is a prospective 1:1 randomized, parallel design, double-masked clinical trial to compare endothelial cell density (ECD), intraocular pressure (IOP) and metagenomic RNA deep sequencing (MDS) between sulcus and anterior chamber (AC) tube placement after glaucoma drainage device (GDD) implantation. The trial has fixed sample size with 12 months follow-up for primary outcome assessment and trial participants will continue to be followed to the end of grant cycle with a total of 24 months follow-up. Patients will be randomized to 2 tube locations for GDD implantation: - Tube placed in the AC - Tube placed in ciliary sulcus - Stratification: by clinical center and type of surgery (GDD alone vs GDD combined with phacoemulsification). Stratified randomization by clinical center is to ensure that a similar number of subjects will be randomized to either sulcus tube or AC tube placement for a specific clinical center. Because eyes undergoing a combined phacoemulsification with GDD implantation may be associate with larger ECL from phacoemulsification, stratified by surgery type is to ensure two tube location groups similar number of study eyes that will undergo a combined phacoemulsification with GDD implantation.

Evaluation of Outcomes Following In-office Tympanostomy Using the Tula® System: a Prospective, Multi-center Registry

The Utility of Treatment With Nasogastric Tube Placement for Small Bowel Obstruction

Assessment of Swallowing Function and Quality of Life in Oropharyngeal Cancer Patients Treated by Chemo-radiotherapy

Open-label, interventional, multicentric, randomized, phase III study. Cancer studied is the oropharyngeal cancer. Study is composed by 2 arms of subjects (male or female): prophylactic or reactive percutaneous endoscopic gastrostomy tube placement. The arm will be allocated by randomisation (1:1). - Prophylactic PEG (pPEG): Prophylactic PEG tube will be placed before the start of the study treatment (CRT). The enteral nutrition will start following the assessment by the clinical dietitian in order to complete the current oral consumption according to the estimated energy needs (on the basis of 30 to 35 kcal / kg adapted and 1.2 to 1.5 g / prot./ kg.BW) with an increase as needed during the treatment. - Reactive PEG (rPEG): Reactive PEG tube will be placed and enteral nutrition initiated, during the study treatment period in case of decrease of oral intake less than 2/3 of estimated energy requirements (based on 30-35 kcal / adapted kg .BW and 1.2 - 1.5 g/prot./adapted kg. BW) for a period of or anticipated to be, greater than 7 days or weight loss ≥ 5% from pre-treatment baseline). All subjects will be treated with a cisplatin standard chemotherapy regimen and by simultaneous integrated boost (SIB) intensity modulated radiotherapy (IMRT). Cisplatin: Two therapeutic regimens are allowed: - Days 1 and 22: cisplatin 100mg/m2 IV - Days 1,8,15,22,29 and 39: weekly cisplatin 40mg/m2 IV Radiotherapy: The median dose prescription will be 32 x 2.16 Gy to the high risk PTV and 32 x 1.75 Gy to the elective PTV. Medical device: The medical device used in this trial is a percutaneous endoscopic gastrostomy tube with the CE label: CE0120. The medical device is used in the indication of the notice. The estimated number of subjects to screen is 121 patients for an estimated number of 110 patients randomised for 100 evaluable patients. The end of study will be declared when all the following criteria will have been met: - The study ends after last visit of the last patient remaining in the study. - The trial is mature for the analysis of the endpoints as defined in the protocol, if the trial reaches its endpoints. - The database has been fully cleaned and frozen for all analyses.

Gastric Ultrasound Feeding Tube Placement Confirmation Study

Objective: To evaluate the effectiveness of ultrasound Doppler in determining the correct placement of gastric feeding tubes (GFTs) in intensive care patients compared to the standard of care, chest X-ray (CXR). Study Design: A diagnostic study involving ICU patients who require GFT placement or replacement. Background: Misplacement of GFTs is a common complication in ICU settings, with significant potential consequences for patient safety. Ultrasound Doppler has emerged as a potential alternative to CXR for confirming GFT placement due to its portability, ease of use, and real-time assessment. Methods: Subject Selection: Subjects will be recruited from the ICU at the Leiden University Medical Center (LUMC) who meet the inclusion criteria: tracheally intubated, require GFT placement or replacement, and provide informed consent. Ultrasound Procedure: At the esophageal and gastric levels, ultrasound will be performed using a Philips Lumify® S4-1 broad band sector array transducer. An antrum Doppler window will be set to visualize the "mosaic sign," a characteristic Doppler signal indicative of correct GFT placement. Image Acquisition and Coding: During ultrasound, 20 ml of air will be injected through the GFT, and images will be captured. These images will be anonymized and labeled with the depth at which the insufflation occurred (20 cm or 50 cm) or the location of the insufflation (tracheal suction catheter). Ultrasound Interpretation: An intensivist expert in ultrasound will blind to the original localization of the GFT analyze the anonymized images. The intensivist will classify each image as having a "mosaic sign present" or "mosaic sign absent." Correlation with CXR: The ultrasound interpretation will be compared to the gold standard of CXR to determine the sensitivity and specificity of ultrasound Doppler. Secondary Objectives: - Investigate the correlation between false positive and false negative results and patient characteristics such as gender, BMI, positive end-expiratory pressure (PEEP), tidal volume, and presence of abdominal gas in CXR. - Assess the safety of ultrasound Doppler in terms of adverse events (AEs) and serious adverse events (SAEs). Sample Size: A sample size of 58 patients is expected to provide sufficient power to detect statistically significant differences in sensitivity and specificity between ultrasound Doppler and CXR. Ethical Considerations: Ethical Approval: The study protocol has been approved by the Leiden University Medical Center Ethical Review Board (LUMC-ERB). Informed Consent: All participants will provide informed consent prior to undergoing ultrasound Doppler and CXR. Safety Monitoring: Adverse events will be monitored and reported as per the regulations of the LUMC and the Medical Research Involving Human Subjects Act (WMO). Administrative Aspects: Data Collection and Storage: Patient and clinical data, including anonymized ultrasound images and CXRs, will be collected and stored using the Castor cloud-based clinical data management system. Monitoring: The study will be monitored by internal monitors of the Leiden University Medical Center (LUMC). Reporting: Annual progress reports will be submitted to the accredited METC, and the final study report will be submitted upon completion of the study. Expected Findings: Ultrasound Doppler is expected to demonstrate high sensitivity and specificity in determining the correct placement of GFTs in ICU patients compared to CXR. Potential correlation between false positive and false negative results with certain patient characteristics, such as gender, BMI, and presence of abdominal gas in CXR, may be identified. The safety profile of ultrasound Doppler is expected to be favorable with minimal AEs and no SAEs. Conclusion: This study aims to evaluate the efficacy of ultrasound Doppler in determining the correct placement of GFTs in ICU patients. The findings of this study will contribute to the development of non-invasive methods for confirming GFT placement, potentially improving patient safety and reducing the need for CXRs.

Diagnostic Accuracy of Capnography in Nasogastric Tube Placement

A prospective observational diagnostic study will be conducted. Patients ≥ 18-year-old and requiring the insertion of an nasogastric tube will be recruited using a convenience sampling method from general medical and geriatric wards, intensive care units (ICUs), accident and emergency departments (AEDs), and subacute/rehabilitation/infirmary wards in 21 acute or subacute/convalescent/extended care hospitals. End-tidal carbon dioxide (ETCO2) detection by sidestream capnography, which indicates airway intubation of an nasogastric tube when a capnogram waveform or an ETCO2 level > 10 mmHg, will serve as the index test. The reference standards will be the pH value of gastric content aspiration (pH ≤ 5.5 indicates gastric placement) and X-ray performed after the index test. Each participant will be included only once. Sensitivity, specificity, positive predictive value, and negative predictive value, and the area under the receiver operating characteristic curve of capnography will be calculated to assess the diagnostic performance of capnography. The variability in diagnostic accuracy in participants with different characteristics will be compared. The time spent and the cost of the index test and the reference test will be compared. This study will provide evidence on the diagnostic accuracy of capnography in verifying nasogastric tube placement and inform the update of clinical practice guidelines and stakeholders' decisions regarding the adoption of ETCO2 detection as a routine method for verifying nasogastric tube placement.

Comparison of Ultrasound Methods for Assessment of Endotracheal Tube Placement

In emergency medicine, endotracheal intubation (ETI) is commonly performed for patients who require airway management due to acute respiratory failure, inadequate oxygenation or ventilation, or an inability to protect the airway resulting from altered consciousness. When ETI is performed outside of a cardiac arrest scenario, a series of steps are followed to optimize the procedure. These steps aim to prevent hypoxia, maintain hemodynamic stability, reduce the risk of aspiration, and increase the success rate of ETI. This methodical approach is known as Rapid Sequence Intubation (RSI). RSI involves preparing the necessary and auxiliary equipment, administering premedication, ensuring oxygenation, and applying anesthetic and neuromuscular blocking agents, followed by the placement of the endotracheal tube (ETT). The procedure concludes with confirming the ETT's placement and providing post-intubation care. The primary goal of ETI is to position the ETT through the vocal cords into the trachea, ensuring that both lungs are ventilated effectively. Incorrect or unrecognized endobronchial intubation can result in hypoventilation and collapse of the non-ventilated lung, while the over-ventilated lung may suffer barotrauma or pneumothorax. Unrecognized esophageal intubation, on the other hand, can lead to failure in ventilation, resulting in hypoxia and subsequent complications, including brain damage and other morbidities. Therefore, ensuring the correct placement of the ETT is crucial to avoid serious adverse outcomes. Various methods have been described to confirm correct ETT placement, including direct visualization during intubation, observation of chest wall movements, bilateral auscultation of lung sounds, end-tidal carbon dioxide (EtCO2) monitoring, fiberoptic bronchoscopy, and chest X-ray. Among these, capnography is considered the gold standard. However, in specific clinical situations, EtCO2 monitoring may be unreliable. Patients in cardiac arrest, patients with severe hypotension, pulmonary embolism, or poor pulmonary reserve may present lower than expected EtCO2 values. Similarly, gastric insufflation, using antacids, or consuming carbonated beverages may result in false-positive readings. The American College of Emergency Physicians (ACEP) guidelines recommend the use of additional confirmation methods after ETT placement. Ultrasound (US) has emerged as a relatively new technique for confirming ETI. Its advantages include being non-invasive, portable, rapid, and capable of providing real-time, accurate results. Additionally, the US is unaffected by environmental noise, which can be challenging in noisy environments such as the emergency department. It is also not influenced by changes in pulmonary blood flow. Several ultrasound techniques have been described to confirm ETT placement. The most commonly used methods include direct visualization of the ETT during intubation (tracheal ultrasound), detection of the "lung sliding" sign via lung ultrasound to indicate lung aeration and bilateral identification of diaphragmatic movement. Tracheal ultrasound can detect esophageal intubation before ventilation begins, preventing unnecessary gastric insufflation and its associated complications. The lung sliding sign and bilateral diaphragmatic movement techniques can help identify endobronchial intubation by visualizing pleural and diaphragmatic movement, respectively, thereby complementing tracheal ultrasound and reducing the risk of missed endobronchial intubation. A comprehensive literature review revealed that no studies have directly compared these three ultrasound methods. Therefore, this study aims to evaluate the effectiveness of these three ultrasound techniques in confirming ETT placement and to compare the time required for each method. A secondary objective is to compare the time spent using ultrasound with that of auscultation and capnography. Additionally, this study will assess the ability of each ultrasound technique to detect tracheal intubation and, if present, accidental esophageal intubation across all patients.

Role of Point of Care Ultrasound in Endotracheal Tube Placement

Role of point of care ultrasound in confirmation of endotracheal tube placement in children

Pigtail or Chest Tube Placement After Uniportal Video-assisted Thoracoscopic Surgery

Design A randomized controlled trial. Setting The uniportal VATS has a small linear wound about 3 to 5 cm at only one intercostal space, mostly 4th or 5th. After elective thoracic surgery, the investigators routinely placed either one 14-Fr pigtail catheter or one 20-Fr chest tube for postoperative drainage. The patients regularly receive thoracoscopic internal costal nerve block with 10 mL of 1% Ropivacaine at the end of the operation, and are routinely prescribed with oral Tramadol 37.5mg and Acetaminophen 325mg four times a day postoperatively and intravenous morphine as extra dose if need. The investigators check chest X ray on postoperative day one and try to remove the drainage tube soon if well lung expansion and ambulation without adverse events. Then the investigators will discharge this patient six hours later or the next day after drain removal smoothly. Sample size determination and statistical analysis The patient number in one group will be calculated on the basis of significant pain relief and set as 33 patients with the following statistic parameter: α: 0.05 (type I error probability), power 0.8 (probability of correctly rejecting the null hypothesis), δ: 0.5 (difference in population means), σ: 1 (standard deviation of difference). The investigators added 20 % noncompliance rate and forty patients in each group (total eighty patients) will be included in this study. Participants The investigators enrolled eighty consecutive adult patients, over 20 years old, undergoing elective uniportal VATS lung resection, pleural tumor removal or mediastinal lymph node biopsy, etc. The exclusion criteria are patient refusal, body mass index > 27 kg/m2, American society of anesthesiologists (ASA) grade above 3, contraindication to nerve block, allergy to analgesic agents, regular opioid used for chronic pain prior to this time surgery, anticipating postoperative patient control analgesia (PCA) before operation, surgeon's decision for exclusion during operation, conversion to thoracotomy or multiportal VATS procedure, postoperative intubation, postoperative intensive care unit admission. Interventions Eighty adult patients, over 20 years old, were allocated randomly in a 1:1 ratio by computer-generated randomization to receive either one 14-Fr pigtail catheter or one 20-Fr chest tube for postoperative pleural drainage. Measurement / Result The patient demographics, comorbidities, and thoracic surgical procedure, intra-operative blood loss, operative time, pathological results are reviewed. The evaluation and measurement of primary and secondary outcomes are recorded by nurses or assistants at post-anesthetic care unit and ward. The independent samples t test, Chi-square test, Logistic Regression will be used for data analysis. Primary outcome The resting and dynamic VAS (Visual Analogue Scale) while coughing and ambulation after operation 0, 2, 4, 8, 24, 48 hours are collected, as well as the postoperative nausea or vomiting episodes related to anesthesia or analgesia. The investigators also record the first-time usage of intravenous morphine, cumulative intravenous morphine consumption in the first two postoperative days, and, if need, the additional analgesic agent or rescue analgesia requirement, such as patient controlled analgesia. Secondary outcome The investigators record the function and daily amount of the pleural drainage, the interpretation of postoperative day one chest X ray, any attempts of additional pleural drain insertion or conversion to tube thoracotomy from pigtail catheter if need. In addition, the timing of chest tube removal, length of hospital stays, and surgical pulmonary complications or morbidity are also noted. Conclusion The investigators will discover if the small-bore pigtail catheter placement would be equally or superiorly effective over analgesia and the following early recovery postoperatively after uniportal VATS, comparing to traditional chest tube. Then the protocol of minimally invasive thoracic operation will be revised and advanced.

Nitrous Oxide for Analgesia During Nasogastric Tube Placement in Young Children

In the context of mild to moderate dehydration in young children, enteral rehydration is the treatment of choice because it is more physiological than parenteral rehydration which has more serious side effects. Thus, nasogastric tube placement has become a more common procedure in the pediatric emergency care setting. Although, it is widely accepted that this procedure is invasive and painful, to date, no analgesic approach has been shown to be effective for children aged 3 months to 3 years. Currently, standard care is the placement of nasogastric tube without any analgesic intervention. Inhalation of nitrous oxide mixed with oxygen (50/50) has been shown to be effective to reduce pain and anxiety induced by invasive procedures in children, adolescents and adults. Its use is very safe and it is associated with only minor and transient side effects such as nausea, vomiting or dizziness in les than 10% of patients. Its use is very common in many countries such as France, United Kingdom, The Netherlands or Australia. The investigators hypothesized that its inhalation would reduce pain during nasogastric tube placement in young children. The purpose of this study is to evaluate the analgesic efficacy of 50%/50% nitrous/oxide mixture in reducing pain induced by nasogastric tube insertion in children aged 3 months to 3 years in the pediatric emergency department. A randomized controlled trial will be performed in two pediatric emergency departments to assess the efficacy of 50/50 nitrous oxide/oxygen during nasogastric tube insertion. The control group will receive standard care. Primary outcome: Pain assessed with the FLACC scale during tube insertion The investigators believe that this randomized study comparing nitrous oxide inhalation against current practice (no analgesic means) will highlight the intensity of pain caused by nasogastric tube placement and will assess the effectiveness of nitrous oxide inhalation to reduce pain and anxiety induced by the procedure