Actively Recruiting
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.
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-04-13
1084
Participants Needed
29
Research Sites
79 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults (≥ 18 years old)
- Admitted in the ICU for ≤ 24 hours
- De novo hypoxemic acute respiratory failure defined by all three: respiratory rate > 25 breaths/min or signs of respiratory distress; PaO2/FiO2 ≤ 200 mmHg under HFNC with flow ≥ 45 L/min; uni or bilateral pulmonary infiltrate on chest X-ray or CT scan
- Informed consent from patient, next of kin, or substitute decision maker, or emergency inclusion if patient unable to consent
You will not qualify if you...
- Refusal of study participation by patient or proxy
- Anatomical factors preventing use of nasal cannula or CPAP
- Long term oxygen therapy
- Home CPAP or NIV use prior to ICU admission
- Hypercapnia indicating NIV (PaCO2 > 45 mmHg)
- Isolated cardiogenic pulmonary edema indicating NIV
- Known pregnancy or breastfeeding
- No coverage by French statutory health care insurance system
- Abdominal, thoracic, or cardiac surgery within last 6 days
- Use of vasopressors (norepinephrine > 0.3 mcg/kg/min)
- Glasgow coma scale < 13
- Urgent need for endotracheal intubation
- End-of-life stage receiving compassionate oxygenation
- Exacerbation of a chronic respiratory disease
- Legal protection status (curatorship or tutorship)
- Undrained pneumothorax
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 29 locations
1
CHU Amiens-Picardie
Amiens, France, 80054
Not Yet Recruiting
2
CHU Angers
Angers, France, 49933
Not Yet Recruiting
3
Centre Hospitalier Victor Dupouy
Argenteuil, France, 95107
Not Yet Recruiting
4
Hôpital Avicenne
Bobigny, France, 93000
Not Yet Recruiting
5
Centre Hospitalier de Bourg-en-Bresse - Site de Fleyriat
Bourg-en-Bresse, France, 01012
Actively Recruiting
6
Hôpital Louis-Mourier
Colombes, France, 92700
Not Yet Recruiting
7
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, France, 91100
Not Yet Recruiting
8
Hôpital Henri-Mondor
Créteil, France, 94010
Actively Recruiting
9
Centre Hospitalier de Dieppe - Site Pasteur
Dieppe, France, 76200
Actively Recruiting
10
Hôpital François Mitterrand
Dijon, France, 21000
Actively Recruiting
11
Hôpital André Mignot
Le Chesnay, France, 78157
Actively Recruiting
12
Hôpital Bicêtre
Le Kremlin-Bicêtre, France, 94270
Not Yet Recruiting
13
Centre Hospitalier du Mans
Le Mans, France, 72037
Actively Recruiting
14
Hôpital Salengro
Lille, France, 59037
Actively Recruiting
15
Hôpital Édouard Herriot - Hospices Civils de Lyon
Lyon, France, 69003
Actively Recruiting
16
Hôpital de la Croix-Rousse - Hospices Civils de Lyon
Lyon, France, 69004
Actively Recruiting
17
Hôpital Saint-Joseph Saint-Luc
Lyon, France, 69007
Not Yet Recruiting
18
Hôpital Lyon Sud - Hospices Civils de Lyon
Lyon, France, 69495
Not Yet Recruiting
19
Hôpital Lapeyronie
Montpellier, France, 34090
Actively Recruiting
20
CHU de Nantes
Nantes, France, 44000
Not Yet Recruiting
21
Hôpital Pasteur
Nice, France, 06000
Active, Not Recruiting
22
Hôpital de l'Archet
Nice, France, 06200
Actively Recruiting
23
Hôpital Saint-Antoine
Paris, France, 75012
Actively Recruiting
24
APHP - hôpital Pitié-Salpêtrière
Paris, France, 75013
Actively Recruiting
25
Hôpital Tenon
Paris, France, 75020
Actively Recruiting
26
Hôpital la Milétrie
Poitiers, France, 86000
Not Yet Recruiting
27
Hôpital Pontchaillou
Rennes, France, 35000
Not Yet Recruiting
28
Hôpital Charles-Nicolle
Rouen, France, 76000
Actively Recruiting
29
Nouvel hôpital civil
Strasbourg, France, 67000
Actively Recruiting
Research Team
A
Alexandre DEMOULE
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here