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Compares treatment options for De Novo Hypoxemic Acute Respiratory Failure (hARF)
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.
ClinicalTrials.gov ID: NCT06213168
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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.
You likely can't join 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
See the full eligibility criteria
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
- Angers, France
- Argenteuil, France
- Bobigny, France
- Bourg-en-Bresse, France
- Colombes, France
- Corbeil-Essonnes, France
- Créteil, France
- Dieppe, France
- Dijon, France
- Le Chesnay, France
- Le Kremlin-Bicêtre, France
- Le Mans, France
- Lille, France
- Lyon, France
- Montpellier, France
- Nantes, France
- Nice, France
- Paris, France
- Poitiers, France
+ 3 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France; Angers, France; Argenteuil, France; Bobigny, France; Bourg-en-Bresse, France; Colombes, France and 17 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.