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.
Recruiting now · Not applicable
Conditions studied: De Novo Hypoxemic Acute Respiratory Failure (hARF)
In brief
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
Key facts
- Study ID
- NCT06213168
- Run by
- Assistance Publique - Hôpitaux de Paris
- People needed
- 1084
- Starts
- 2025-08-19
- Expected to finish
- 2027-03-01
- Last updated by the study team
- 2026-04-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adults (≥ 18 years old)
- Admitted in the ICU for ≤ 24 hours
- De novo hARF defined by the three following criteria:
- Respiratory rate > 25 breaths/min or signs of respiratory distress such as labored breathing or paradoxical inspiration
- PaO2/FiO2 ≤ 200 mmHg under HFNC with flow ≥ 45 L/min, actual FiO2 being considered.
- Uni or bilateral pulmonary infiltrate on chest X-ray or CT scan
- 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
You may not qualify if…
- Refusal of study participation by the patient or the proxy
- Anatomical factors precluding the use of a nasal cannula or CPAP
- Long term oxygen
- Home CPAP or NIV or CPAP or NIV initiated prior to ICU admission
- Hypercapnia indicating NIV (PaCO2 > 45 mmHg)
- Isolated cardiogenic pulmonary oedema indicating NIV
- Known pregnancy or breastfeeding
- Absence of coverage by the French statutory health care insurance system (including AME)
- Abdominal, thoracic or cardiac surgery within the last 6 days
- Use of vasopressors (norepinephrine>0.3 mcg/kg/min)
- Glasgow coma scale < 13
- Urgent need for endotracheal intubation
- Patients at an end-of-life stage receiving compational oxygenation
- Exacerbation of a chronic respiratory disease
- Legal protection (curatorship or tutorship)
- Undrained pneumothorax
Where it is running
- Nouvel hôpital civil — Strasbourg, France (enrolling)
- Centre Hospitalier de Dieppe - Site Pasteur — Dieppe, France (enrolling)
- Hôpital François Mitterrand — Dijon, France (enrolling)
- Hôpital André Mignot — Le Chesnay, France (enrolling)
- Centre Hospitalier du Mans — Le Mans, France (enrolling)
- Hôpital Salengro — Lille, France (enrolling)
- Hôpital Édouard Herriot - Hospices Civils de Lyon — Lyon, France (enrolling)
- Hôpital de la Croix-Rousse - Hospices Civils de Lyon — Lyon, France (enrolling)
- Hôpital Lapeyronie — Montpellier, France (enrolling)
- Hôpital de l'Archet — Nice, France (enrolling)
- Hôpital Saint-Antoine — Paris, France (enrolling)
- APHP - hôpital Pitié-Salpêtrière — Paris, France (enrolling)
- Hôpital Tenon — Paris, France (enrolling)
- Hôpital Charles-Nicolle — Rouen, France (enrolling)
- Centre Hospitalier de Bourg-en-Bresse - Site de Fleyriat — Bourg-en-Bresse, France (enrolling)
- Hôpital Henri-Mondor — Créteil, France (enrolling)
- CHU Angers — Angers, France
- Centre Hospitalier Victor Dupouy — Argenteuil, France
- Hôpital Avicenne — Bobigny, France
- CHU Amiens-Picardie — Amiens, France
- Hôpital Louis-Mourier — Colombes, France
- Centre Hospitalier Sud Francilien — Corbeil-Essonnes, France
- Hôpital la Milétrie — Poitiers, France
- Hôpital Saint-Joseph Saint-Luc — Lyon, France
- Hôpital Lyon Sud - Hospices Civils de Lyon — Lyon, France
Full record on ClinicalTrials.gov
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