Treating post-operative breathing failure with noninvasive mask ventilation versus high-velocity nasal oxygen
Official title: A Prospective, Randomized Controlled Trial Comparing Noninvasive Ventilation (NIV) Versus High-Velocity Nasal Cannula (HVNC) in the Management of Acute Post-Operative Respiratory Failure
Run by Assiut University · NCT06988111 · Data updated 2026-11-12
This trial will test whether noninvasive ventilation (a tight-fitting mask) or high-velocity nasal oxygen works better at preventing return to a breathing tube in adults who develop breathing failure within 48 hours after major surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 180 (estimated) |
| Sponsor | Assiut University Academic / other |
| Locations | 1 site (Asyut, Assuit) |
| Status | Recruiting |
| Started | December 1, 2025 |
| Main results expected | November 1, 2026 |
| Study ends | January 1, 2027 |
| Registry record updated | September 22, 2026 |
| Trial ID | NCT06988111 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 within 48 hours of major surgery who have PaO2/FiO2 under 200, signs of respiratory distress, and a respiratory rate above 25 breaths per minute, and who do not have contraindications to NIV or HVNI.
✕Probably not a fit
Patients with orofacial trauma or burns, active gastrointestinal bleeding, pregnancy, or other contraindications to noninvasive support are unlikely to benefit from the interventions tested here.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults who develop early postoperative respiratory failure (low PaO2/FiO2 and fast breathing) are randomly assigned to receive either noninvasive ventilation (NIV/BiPAP) or high-velocity nasal insufflation (HVNI/HFNC). Care is started quickly after identification, with continuous oxygen and respiratory monitoring and arterial blood gases measured at set intervals. The main outcome is whether the patient needs reintubation within 72 hours, with secondary outcomes including ICU length of stay, comfort scores, and device-related adverse events. The protocol excludes people with facial trauma, active GI bleeding, or pregnancy and uses a secure web randomization process to ensure balanced allocation.
Why it matters
Potential benefit: If successful, this approach could reduce the need for reintubation, shorten ICU stays, and lower complications like ventilator-associated pneumonia for postoperative patients with respiratory failure.
How similar studies have gone: Previous studies show both NIV and high-flow nasal oxygen can improve oxygenation and reduce reintubation in some groups, but direct head-to-head data in postoperative patients with obstructive or restrictive lung patterns are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria: * Age above 18 years * within 48 hours after major surgery * PAO2/FIO2 less than 200 * Signs of respiratory distress and respiratory rate (RR) more than 25 cycles/minute Exclusion Criteria: * Age below 18 years * Pregnant ladies * Orofacial trauma or burns * Active Gastrointestinal bleeding
Where it's running
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Assuit Univeristy
Asyut, Assuit, Egypt Recruiting
Study contacts
- Principal investigator: Ahmad M. Shaddad, MD — Assuit Univeristy
- Study coordinator: Ahmad M. Shaddad, MD
- Email: shaddad_ahmad@aun.edu.eg
- Phone: +201111171930
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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HFNC During Bronchoscopy for Respiratory Failure
This study tests whether using high-flow nasal oxygen during fiber-optic bronchoscopy is safe and helpful for patients with respiratory failure.
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Using a paravertebral block during thoracic (VATS/RATS) surgery to reduce postoperative complications
This study will try an intraoperative paravertebral block to see if it lowers postoperative complications in adults having VATS or RATS for lung or mediastinal procedures.
-
Nasal High Flow vs NIV for early treatment of AE-COPD with high CO2
This study tests whether nasal high flow can match non-invasive ventilation for adults with an AE-COPD and high carbon dioxide levels treated in the emergency department.
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.