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.
HighCPAP
1 other identifier
interventional
1,084
1 country
29
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2025
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2023
CompletedFirst Posted
Study publicly available on registry
January 19, 2024
CompletedStudy Start
First participant enrolled
August 19, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
April 13, 2026
April 1, 2026
1.3 years
December 18, 2023
April 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mortality
Time to death within the 90 days after randomization
90 days
Secondary Outcomes (16)
Time from randomization to intubation.
28 days
Intensity of dyspnea until intubation as assessed by a visual analogic scale from zero (no dyspnea) to 100 (maximum possible dyspnea).
2, 6, 12 and 24 hours
Respiratory rate
6, 12 and 24 hours
ROX index
6, 12 and 24 hours
Evaluation of intolerance to oxygenation technique until intubation
12 and 24 hours
- +11 more secondary outcomes
Study Arms (2)
HFNC
EXPERIMENTALPatients assigned to the control group will be continuously treated by HFNC. HFNC will be initiated within one hour following randomization.
HFNC with CPAP
EXPERIMENTALPatients assigned to the intervention group will receive high flow nasal oxygen plus CPAP sessions
Interventions
Patients assigned to the control group will be continuously treated by HFNC. HFNC will be initiated within one hour following randomization
Patients assigned to the intervention group will receive high flow nasal oxygen plus CPAP sessions
Eligibility Criteria
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
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)
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
CHU Amiens-Picardie
Amiens, 80054, France
CHU Angers
Angers, 49933, France
Centre Hospitalier Victor Dupouy
Argenteuil, 95107, France
Hôpital Avicenne
Bobigny, 93000, France
Centre Hospitalier de Bourg-en-Bresse - Site de Fleyriat
Bourg-en-Bresse, 01012, France
Hôpital Louis-Mourier
Colombes, 92700, France
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, 91100, France
Hôpital Henri-Mondor
Créteil, 94010, France
Centre Hospitalier de Dieppe - Site Pasteur
Dieppe, 76200, France
Hôpital François Mitterrand
Dijon, 21000, France
Hôpital André Mignot
Le Chesnay, 78157, France
Hôpital Bicêtre
Le Kremlin-Bicêtre, 94270, France
Centre Hospitalier du Mans
Le Mans, 72037, France
Hôpital Salengro
Lille, 59037, France
Hôpital Édouard Herriot - Hospices Civils de Lyon
Lyon, 69003, France
Hôpital de la Croix-Rousse - Hospices Civils de Lyon
Lyon, 69004, France
Hôpital Saint-Joseph Saint-Luc
Lyon, 69007, France
Hôpital Lyon Sud - Hospices Civils de Lyon
Lyon, 69495, France
Hôpital Lapeyronie
Montpellier, 34090, France
CHU de Nantes
Nantes, 44000, France
Hôpital Pasteur
Nice, 06000, France
Hôpital de l'Archet
Nice, 06200, France
Hôpital Saint-Antoine
Paris, 75012, France
APHP - hôpital Pitié-Salpêtrière
Paris, 75013, France
Hôpital Tenon
Paris, 75020, France
Hôpital la Milétrie
Poitiers, 86000, France
Hôpital Pontchaillou
Rennes, 35000, France
Hôpital Charles-Nicolle
Rouen, 76000, France
Nouvel hôpital civil
Strasbourg, 67000, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2023
First Posted
January 19, 2024
Study Start
August 19, 2025
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
March 1, 2027
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
- Access Criteria
- Researchers who provide a methodologically sound proposal.
Data are available upon reasonable request The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.