Status:
NOT_YET_RECRUITING
High Flow Nasal Oxygen for Acute Hypoxemic Respiratory Failure in the Emergency Room
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Respiratory Distress Syndrome, Adult
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of this multicenter, randomized, controlled, open-label trial is to investigate the efficacy of early treatment with HFNO compared with SOT in preventing early deterioration of patients admitt...
Eligibility Criteria
Inclusion
- Age ≥ 18 years;
- PaO2/FiO2 ratio between 250 and 150 mmHg or SpO2/FiO2 ratio between 190 and 274, after at least 15 minutes of spontaneous breathing through a Venturi mask (VM), with a FiO2 targeted at a SpO2 94-97%;
- Respiratory rate(RR)≤35breaths/min,afteratleast15minutesofspontaneous breathing through a VM, with a FiO2 targeted at a SpO2 94-97%;
- PaCO2 ≤ 45 mmHg;
- Unilateral or bilateral infiltrate(s), as detected with chest radiography and/or computed tomography and/or with lung ultrasound not fully explained by effusions, atelectasis, or nodules/masses. Infiltrates at lung ultrasound are defined as presence of focal B-lines, consolidations (with irregular marginal contour, air bronchogram, air trapping sign) and irregularity of the pleural line.
Exclusion
- Respiratory failure due to:
- Acute asthma or COPD exacerbation,
- Cardiac failure or fluid overload as primary cause of respiratory failure;
- Unstable angina or ongoing acute myocardial infarction;
- Acute respiratory acidosis with pH \< 7.35 and PaCO2 \> 45 mmHg;
- Hemodynamic instability and/or use of vasopressors/inotropes;
- Altered mental status (Kelly \>3), see Figure 1;(18)
- Contraindications to NIV (high risk of aspiration pneumonia, impaired airways protection, head-facial trauma and/or burns, uncooperative patient, cranial/thoracic/abdominal open wounds);
- Indications to urgent intubation performed according to the clinician in charge;
- Body Mass Index \> 35 kg/m2;
- Pregnancy;
- Patient's refusal to participate.
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
234 Patients enrolled
Trial Details
Trial ID
NCT06489379
Start Date
July 1 2024
End Date
July 1 2026
Last Update
July 5 2024
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