RecruitingNot ApplicableNCT06213168

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.

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


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

1,084 participants

Start Date

Aug 19, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria7

  • 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

Exclusion Criteria16

  • 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

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Interventions

OTHERHFNC

Patients assigned to the control group will be continuously treated by HFNC. HFNC will be initiated within one hour following randomization

OTHERCPAP and HFNC

Patients assigned to the intervention group will receive high flow nasal oxygen plus CPAP sessions


Locations(29)

CHU Amiens-Picardie

Amiens, France

CHU Angers

Angers, France

Centre Hospitalier Victor Dupouy

Argenteuil, France

Hôpital Avicenne

Bobigny, France

Centre Hospitalier de Bourg-en-Bresse - Site de Fleyriat

Bourg-en-Bresse, France

Hôpital Louis-Mourier

Colombes, France

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, France

Hôpital Henri-Mondor

Créteil, France

Centre Hospitalier de Dieppe - Site Pasteur

Dieppe, France

Hôpital François Mitterrand

Dijon, France

Hôpital André Mignot

Le Chesnay, France

Hôpital Bicêtre

Le Kremlin-Bicêtre, France

Centre Hospitalier du Mans

Le Mans, France

Hôpital Salengro

Lille, France

Hôpital Édouard Herriot - Hospices Civils de Lyon

Lyon, France

Hôpital de la Croix-Rousse - Hospices Civils de Lyon

Lyon, France

Hôpital Saint-Joseph Saint-Luc

Lyon, France

Hôpital Lyon Sud - Hospices Civils de Lyon

Lyon, France

Hôpital Lapeyronie

Montpellier, France

CHU de Nantes

Nantes, France

Hôpital Pasteur

Nice, France

Hôpital de l'Archet

Nice, France

Hôpital Saint-Antoine

Paris, France

APHP - hôpital Pitié-Salpêtrière

Paris, France

Hôpital Tenon

Paris, France

Hôpital la Milétrie

Poitiers, France

Hôpital Pontchaillou

Rennes, France

Hôpital Charles-Nicolle

Rouen, France

Nouvel hôpital civil

Strasbourg, France

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NCT06213168