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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.

RecruitingNAAges 18 Years - anyAllAssistance Publique - Hôpitaux de Paris
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In plain words

What the trial is, and whether it could suit you

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 period

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Adults (≥ 18 years old) 2. Admitted in the ICU for ≤ 24 hours 3. De novo hARF defined by the three following criteria: 1. Respiratory rate \> 25 breaths/min or signs of respiratory distress such as labored breathing or paradoxical inspiration 2. PaO2/FiO2 ≤ 200 mmHg under HFNC with flow ≥ 45 L/min, actual FiO2 being considered. 3. Uni or bilateral pulmonary infiltrate on chest X-ray or CT scan 4. 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 Criteria: 1. Refusal of study participation by the patient or the proxy 2. Anatomical factors precluding the use of a nasal cannula or CPAP 3. Long term oxygen 4. Home CPAP or NIV or CPAP or NIV initiated prior to ICU admission 5. Hypercapnia indicating NIV (PaCO2 \> 45 mmHg) 6. Isolated cardiogenic pulmonary oedema indicating NIV 7. Known pregnancy or breastfeeding 8. Absence of coverage by the French statutory health care insurance system (including AME) 9. Abdominal, thoracic or cardiac surgery within the last 6 days 10. Use of vasopressors (norepinephrine\>0.3 mcg/kg/min) 11. Glasgow coma scale \< 13 12. Urgent need for endotracheal intubation 13. Patients at an end-of-life stage receiving compational oxygenation 14. Exacerbation of a chronic respiratory disease 15. Legal protection (curatorship or tutorship) 16. Undrained pneumothorax
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What it tests

  • HFNC
  • CPAP and HFNC
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Where

29 sites
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

…and 21 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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