High-flow nasal oxygen combined with noninvasive ventilation for acute respiratory failure
Official title: Different Modalities of Combined Noninvasive Ventilation With High Flow Nasal Oxygen Versus Noninvasive Ventilation Alone in Acute Respiratory Failure
Run by Minia University · NCT07521254 · Data updated 2026-11-12
This test will try alternating high-flow nasal oxygen and noninvasive ventilation to see if it helps adults with acute respiratory failure breathe better than noninvasive ventilation alone.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 75 (estimated) |
| Sponsor | Minia University Academic / other |
| Locations | 1 site (Minya, Minya Governorate) |
| Status | Recruiting |
| Started | June 1, 2025 |
| Main results expected | April 2026 |
| Study ends | May 2026 |
| Registry record updated | April 9, 2026 |
| Trial ID | NCT07521254 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with acute respiratory failure defined by PaO2/FiO2 < 300 after 15 minutes of conventional face-mask oxygen with FiO2 ≥ 50% and respiratory rate > 30 breaths/min, who meet ASA I–III and can tolerate noninvasive support.
✕Probably not a fit
Patients with chronic respiratory disease, cardiogenic pulmonary edema, life-threatening arrhythmias, hemodynamic instability requiring vasopressors, facial abnormalities preventing interface use, low Glasgow Coma Score (≤12), marked agitation, immediate need for intubation, or pregnancy are unlikely to benefit from enrollment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, randomized, non-blind comparison conducted in the adult ICU at Minia University Hospital enrolling 75 patients with acute respiratory failure. Participants are randomized into three equal groups: one group receives cycles of 2 hours HFNC then 1 hour NIV, a second group receives 3 hours HFNC alternating with 3 hours NIV, and a control group receives conventional oxygen therapy with NIV as needed. HFNC is delivered using a Vapotherm system with an initial flow of 50 L/min and FiO2 0.5, titrated to maintain SpO2 ≥ 92% and blood gases checked after starting HFNC. The primary interventions are applied during the first 24 hours and outcomes will compare oxygenation, need for intubation, and tolerance between protocols.
Why it matters
Potential benefit: If successful, alternating HFNC and NIV could improve oxygenation and comfort and reduce the need for invasive mechanical ventilation.
How similar studies have gone: Previous studies have shown HFNC can reduce intubation in some forms of hypoxemic respiratory failure, but alternating HFNC/NIV protocols like these are less well studied and have limited direct evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 year of both sexes. • Diagnosed with Acute Respiratory Failure (ARF) defined as the combination of a PaO2/FiO2 ratio \< 300 after 15 minutes of conventional oxygen delivered through a face mask, with a FiO2 at least of 50% and respiratory rate \> 30 breaths/min. Exclusion Criteria: * Chronic respiratory disease * Cardiogenic pulmonary edema * Life-threatening arrythmias * Hemodynamic instability requiring vasopressors * Facial abnormalities preventing NIV or HFNC application * Glasgow coma score of ≤ 12 points (Teasdale et al. 1974) * Agitated patients characterized by RASS score (Richmond Agitation Sedation Scale) ≥ +2 * Patients who needed immediate endotracheal intubation * Pregnant patients
Where it's running
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Minya university hospitals
Minya, Minya Governorate, Egypt Recruiting
Study contacts
- Principal investigator: Omyma S Mohamed, Prof. — ahmed_ezz@mu.edu.eg
- Study coordinator: Omyma S Mohamed, Prof.
- Email: Omaima.Shehata@mu.edu.eg
- Phone: 0106 1762894
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.