Comparing High-flow Nasal Cannula Oxygen and Noninvasive Ventilation to Standard Oxygenation in Non-selected ICU Patients Admitted for Hypoxemic ARF

Launched by UNIVERSITY HOSPITAL, MONTPELLIER · Mar 31, 2023

Keywords

ClinConnect Summary

This clinical trial is looking to find out if two specific types of oxygen therapy—High-flow Nasal Cannula Oxygen (HFNO) and Noninvasive Ventilation (NIV)—are better than standard oxygen treatment for patients with a serious lung condition called hypoxemic acute respiratory failure (ARF). The main goal is to see if these therapies can help reduce the number of patients who die within 28 days of being treated.

To participate in the study, individuals must be adults (18 years or older) diagnosed with hypoxemic ARF, which is characterized by low oxygen levels in the blood. However, people with certain conditions, like severe sleep apnea or those needing immediate intubation, cannot join. If eligible, patients will receive either standard oxygen, HFNO, or NIV and will be monitored throughout their treatment. This trial is currently recruiting and aims to gather important information that could improve care for patients with severe breathing issues.

Gender

ALL

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