Status:
NOT_YET_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.
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
De Novo Hypoxemic Acute Respiratory Failure (hARF)
Eligibility:
All Genders
18+ years
Phase:
NA
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 rat...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
- 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
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
1084 Patients enrolled
Trial Details
Trial ID
NCT06213168
Start Date
September 1 2024
End Date
March 1 2027
Last Update
July 19 2024
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