NCT05812911 Comparing High-flow Nasal Cannula Oxygen and Noninvasive Ventilation to Standard Oxygenation in Non-selected ICU Patients Admitted for Hypoxemic ARF
| NCT ID | NCT05812911 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Montpellier |
| Condition | Acute Respiratory Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,100 participants |
| Start Date | 2023-05-23 |
| Primary Completion | 2026-05-23 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,100 participants in total. It began in 2023-05-23 with a primary completion date of 2026-05-23.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to determine whether one of the two oxygenation or ventilation strategies (NIV and/or HFNO) is superior to standard oxygen to reduce 28-day mortality rate in hypoxemic acute respiratory failure (ARF) patients.
Eligibility Criteria
Inclusion Criteria: * Adult (age ≥ 18 years) * A diagnosis of hypoxemic ARF occurring defined as the presence and persistence for more than 30 minutes of hypoxemia (defined by a partial oxygen pressure \<60 mm Hg when breathing room air or \<80 mmHg when breathing 15 L/min of oxygen or a peripheral oxygen saturation \[SpO2\] ≤90% when breathing room air and/or a PaO2(partial pressure of oxygen)/FiO2 ratio \< 300 mmHg plus either \[1\] a respiratory rate higher than 30/min or \[2\] clinical signs suggestive of intense respiratory muscle work and/or labored breathing, such as use of accessory respiratory muscles, paradoxical motion of the abdomen, or intercostal retraction). Exclusion Criteria: * Contraindications to NIV and/or HFNO * Sleep apnea syndrome with home ventilator * Immediate tracheal intubation * Requirement for an emergent surgical procedure requiring intubation * Hypercapnia with a formal indication for NIV (formal indication for NIV with PaCO2 ≥ 50 mmHg or clinical signs of hypercapnia) * Isolated cardiogenic pulmonary edema (formal indication for NIV). Patients with pulmonary edema associated with another ARF etiology can be included. * Anatomical factors precluding the use of NIV and/or HFNO * Patients with limitation or withdrawal of life-sustaining therapies with a do-not-intubate order * Pregnancy in progress or planned during the study period or breastfeeding women * Patients protected by law (Art. L1121-6 and L1121-8 of the Code de la Santé Publique): Adult protected by law or patient under guardianship or curatorship * Subjects not covered by public health insurance * Absence of written informed consent from the patient or his or her proxy (if present) before inclusion or when possible when the patient has been included in an emergency setting
Contact & Investigator
Samir Jaber, MD, PhD
STUDY DIRECTOR
Department of anaesthesia and ICU Saint-Eloi Hospital, Montpellier University Hospital
Frequently Asked Questions
Who can join the NCT05812911 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Respiratory Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05812911 currently recruiting?
Yes, NCT05812911 is actively recruiting participants. Contact the research team at s-jaber@chu-montpellier.fr for enrollment information.
Where is the NCT05812911 trial being conducted?
This trial is being conducted at Montpellier, France.
Who is sponsoring the NCT05812911 clinical trial?
NCT05812911 is sponsored by University Hospital, Montpellier. The principal investigator is Samir Jaber, MD, PhD at Department of anaesthesia and ICU Saint-Eloi Hospital, Montpellier University Hospital. The trial plans to enroll 2,100 participants.