Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
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.

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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

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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. | DecenTrialz