Comparing High-flow Nasal Cannula Oxygen and Noninvasive Ventilation to Standard Oxygenation in Non-selected ICU Patients Admitted for Hypoxemic ARF

Not Applicable

Recruiting

• Conditions: Acute Respiratory Failure

• Registration Number: NCT05812911
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

The goal of this clinical trial is to determine whether one of the two oxygenation or ventilation strategies (NIV and/or HFNO) is superior to standard oxygen to reduce 28-day mortality rate in hypoxemic acute respiratory failure (ARF) patients.

Detailed Description

This randomized controlled trial is a superiority study to test if one of the methods (NIV and/or HFNO) is superior to standard oxygen in ARF patients requiring oxygen. It is an investigator-initiated, multicenter, adaptive, three arms parallel-group trial with a computer-generated allocation sequence and an electronic system-based randomization, with a stratification on medical (then stratification between immunocompromised and non-immunocompromised patients) versus surgical (then stratification between cardiothoracic and abdominal patients).

Study Timeline

• Study First Submitted: 2023-03-31
• Study First Submitted QC: 2023-03-31
• Study First Posted: 2023-04-14
• Study Start: 2023-05-23
• Status Verified: 2025-04
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-07
• Primary Completion: 2026-05-23
• Study Completion: 2026-08-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2100

Inclusion Criteria

• Adult (age ≥ 18 years)
• A diagnosis of hypoxemic ARF occurring defined as the presence and persistence for more than 30 minutes of hypoxemia (defined by a partial oxygen pressure <60 mm Hg when breathing room air or <80 mmHg when breathing 15 L/min of oxygen or a peripheral oxygen saturation [SpO2] ≤90% when breathing room air and/or a PaO2(partial pressure of oxygen)/FiO2 ratio < 300 mmHg plus either [1] a respiratory rate higher than 30/min or [2] clinical signs suggestive of intense respiratory muscle work and/or labored breathing, such as use of accessory respiratory muscles, paradoxical motion of the abdomen, or intercostal retraction).

Exclusion Criteria

• Contraindications to NIV and/or HFNO
• Sleep apnea syndrome with home ventilator
• Immediate tracheal intubation
• Requirement for an emergent surgical procedure requiring intubation
• Hypercapnia with a formal indication for NIV (formal indication for NIV with PaCO2 ≥ 50 mmHg or clinical signs of hypercapnia)
• Isolated cardiogenic pulmonary edema (formal indication for NIV). Patients with pulmonary edema associated with another ARF etiology can be included.
• Anatomical factors precluding the use of NIV and/or HFNO
• Patients with limitation or withdrawal of life-sustaining therapies with a do-not-intubate order
• Pregnancy in progress or planned during the study period or breastfeeding women
• Patients protected by law (Art. L1121-6 and L1121-8 of the Code de la Santé Publique): Adult protected by law or patient under guardianship or curatorship
• Subjects not covered by public health insurance
• Absence of written informed consent from the patient or his or her proxy (if present) before inclusion or when possible when the patient has been included in an emergency setting

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Day-28 mortality	Up to Day-28	Mortality rates at Day-28

Secondary Outcome Measures

Name	Time	Method
Oxygenation up to Day-7	Up to Day-7	Proportion of patients with better oxygenation
Mortality rates in hospital	Up to Day-90	Mortality rates in hospital
Day-90 mortality	Day-90	Mortality rates at Day-90
Intubation rate at Day-28	Day-28	Proportion of patients requiring invasive mechanical ventilation
Intubation rate at Day-3	Day-3	Proportion of patients requiring invasive mechanical ventilation
Intubation rate at Day-7	Day-7	Proportion of patients requiring invasive mechanical ventilation
Need of other rescue oxygen therapy up to Day-7	Up to Day-7	Proportion of patients requiring rescue oxygen therapy
ICU length of stay	Up to Day-90	Duration time in ICU
Hospital length of stay	Up to Day-90	Duration time in Hospital
Mortality rates in ICU	Up to Day-90	Mortality rates in ICU
Adverse events	Up to Day-90	Related to the treatment

Trial Locations

Locations (1)

Montpellier University Hospital - Saint Eloi Hospital; 🇫🇷 Montpellier, France