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CPAP plus high-flow nasal oxygen versus high-flow alone for adults with new-onset hypoxemic respiratory failure

Impact on Mortality of a Strategy Including Continuous Positive Airway Pressure Plus High Flow Nasal Cannula Oxygen Therapy Versus High Flow Nasal Cannula Oxygen Therapy Alone in Patients With de Novo Acute Hypoxemic Respiratory Failure: a Prospective, Randomized Controlled Trial

NA · Assistance Publique - Hôpitaux de Paris · NCT06213168

This trial tests whether adding CPAP to high-flow nasal oxygen can reduce deaths in adults recently admitted to the ICU with new-onset hypoxemic respiratory failure.

Quick facts

PhaseNA
Study typeInterventional
Enrollment1084 (estimated)
Ages18 Years and up
SexAll
SponsorAssistance Publique - Hôpitaux de Paris (other)
Locations29 sites (Amiens and 28 other locations)
Trial IDNCT06213168 on ClinicalTrials.gov

What this trial studies

This is a randomized controlled trial that enrolls adults admitted to the ICU within 24 hours for de novo hypoxemic acute respiratory failure and randomizes them to receive high-flow nasal cannula (HFNC) oxygen alone or HFNC plus continuous positive airway pressure (CPAP). Eligible patients must have a PaO2/FiO2 ≤ 200 while on HFNC at ≥45 L/min and radiographic pulmonary infiltrates. The trial compares mortality and rates of intubation between the two respiratory support strategies using predefined ICU criteria for escalation. It is conducted at multiple French hospital ICUs with standard monitoring and consent procedures for emergency admissions.

Who should consider this trial

Good fit: Adults admitted to an ICU within 24 hours for new-onset (de novo) hypoxemic respiratory failure with PaO2/FiO2 ≤ 200 on HFNC at ≥45 L/min and pulmonary infiltrates on chest imaging are ideal candidates.

Not a fit: Patients with chronic home oxygen or home CPAP/NIV, those with hypercapnia, isolated cardiogenic pulmonary edema, anatomical contraindications to nasal cannula or CPAP, known pregnancy, or who are not at a participating center are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, adding CPAP to HFNC could lower the need for intubation and reduce deaths in patients with de novo hypoxemic respiratory failure.

How similar studies have performed: Previous trials comparing HFNC to standard oxygen have shown mixed results and the idea of adding CPAP is plausible but has limited definitive randomized evidence to date.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Adults (≥ 18 years old)
2. Admitted in the ICU for ≤ 24 hours
3. De novo hARF defined by the three following criteria:

   1. Respiratory rate \> 25 breaths/min or signs of respiratory distress such as labored breathing or paradoxical inspiration
   2. PaO2/FiO2 ≤ 200 mmHg under HFNC with flow ≥ 45 L/min, actual FiO2 being considered.
   3. Uni or bilateral pulmonary infiltrate on chest X-ray or CT scan
4. Informed consent from the patient or her/his next of kin or another substitute decision maker, or inclusion procedure in emergency if the patient is unable to consent

Exclusion Criteria:

1. Refusal of study participation by the patient or the proxy
2. Anatomical factors precluding the use of a nasal cannula or CPAP
3. Long term oxygen
4. Home CPAP or NIV or CPAP or NIV initiated prior to ICU admission
5. Hypercapnia indicating NIV (PaCO2 \> 45 mmHg)
6. Isolated cardiogenic pulmonary oedema indicating NIV
7. Known pregnancy or breastfeeding
8. Absence of coverage by the French statutory health care insurance system (including AME)
9. Abdominal, thoracic or cardiac surgery within the last 6 days
10. Use of vasopressors (norepinephrine\>0.3 mcg/kg/min)
11. Glasgow coma scale \< 13
12. Urgent need for endotracheal intubation
13. Patients at an end-of-life stage receiving compational oxygenation
14. Exacerbation of a chronic respiratory disease
15. Legal protection (curatorship or tutorship)
16. Undrained pneumothorax

Where this trial is running

Amiens and 28 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: De Novo Hypoxemic Acute Respiratory Failure, Continuous positive airway pressure, High flow nasal cannula oxygen therapy, De novo hypoxemic acute respiratory failure, Intensive care unit, Mortality, Mechanical ventilation, Non-invasive ventilation

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.