Last updated: January 2, 2024
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Overall Status: Active - Recruiting
Phase
N/A
Condition
Respiratory Failure
Lung Injury
Treatment
Noninvasive respiratory support
Clinical Study ID
NCT05089695
HENIVOT2
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Acute symptoms of respiratory failure PaO2/FiO2 ratio ≤ 200; PaCO2≤45mmHg; Absence ofhistory of chronic respiratory failure or moderate to severe cardiac insufficiency (NYHA>2 or left ventricular ejection fraction<50%); Informed consent Patients that have already received NIV, CPAP continuously for more than 24 hours beforethe screening visit will be excluded.
Exclusion
Other Exclusion Criteria:
- Pregnancy;
- Exacerbation of asthma or chronic obstructive pulmonary disease;
- Hypercapnia (PaCO2>45 mmHg) with or without respiratory acidosis;
- More than 2 organ failures, including the lung.
- Documented pneumothorax;
- Clinical diagnosis of Cardiogenic pulmonary edema;
- Haemodynamic instability (Systolic blood pressure<90 mmHg or mean arterialpressure<65mmHg) and/or lactic acidosis (lactate>5 mmol/L) and/or clinically diagnosedShock requiring administration of vasoactive agents (norepinephrine>0.1 mcg/Kg/min);
- Metabolic Acidosis (pH <7.30 with normal- or hypo-carbia);
- Chronic kidney failure requiring dialysis before ICU admission;
- Chronic hypoxemic respiratory failure requiring long-term oxygen therapy;
- Altered neurological status that requires immediate intubation and/or making thepatient uncooperative;
- Urgent need for endotracheal intubation, according to the decision of the attendingphysician;
- Do not intubate order;
- Decision of withdrawal of life-sustaining therapy;
- Thoracic or abdominal surgery in the previous 7 days;
- Any condition that makes the patient very likely to require endotracheal intubationdue to a reason different from respiratory failure;
- Recent head surgery or anatomy that prevent the application of helmet or HFNC topatient's face.
Study Design
Total Participants: 1200
Treatment Group(s): 1
Primary Treatment: Noninvasive respiratory support
Phase:
Study Start date:
March 01, 2022
Estimated Completion Date:
June 30, 2026
Study Description
Connect with a study center
Gemelli
Rome,
ItalyActive - Recruiting
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