NCT06213168 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.
| NCT ID | NCT06213168 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | De Novo Hypoxemic Acute Respiratory Failure (hARF) |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,084 participants |
| Start Date | 2025-08-19 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,084 participants in total. It began in 2025-08-19 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
De novo hypoxemic acute respiratory failure (hARF) is one of the main causes of intensive care unit (ICU) admission. In de novo hARF, intubation is associated with a dramatic increase in mortality rate. Compared to standard oxygen, the use of high-flow oxygen nasal cannula (HFNC) might be beneficial to prevent intubation and mortality, although the results of trials and meta-analyses are conflicting. Even with HFNC, the intubation rate remains high. This is the reason why adjunctive therapies, administered in addition to HFNC are needed. Continuous positive airway pressure (CPAP) is one of these adjunctive therapies. CPAP provides high level of positive end-expiratory pressure that ensures lung recruitment, but without adding inspiratory pressure support, which prevents ventilator induced lung injury. In addition, as opposed to pressure support, CPAP is well tolerated during long periods of time. Therefore, applying CPAP in addition to HFNC may reduce intubation rate and in turn mortality rate. The present trial will evaluate the 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
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06213168 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying De Novo Hypoxemic Acute Respiratory Failure (hARF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06213168 currently recruiting?
Yes, NCT06213168 is actively recruiting participants. Contact the research team at alexandre.demoule@aphp.fr for enrollment information.
Where is the NCT06213168 trial being conducted?
This trial is being conducted at Amiens, France, Angers, France, Argenteuil, France, Bobigny, France and 11 additional locations.
Who is sponsoring the NCT06213168 clinical trial?
NCT06213168 is sponsored by Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 1,084 participants.