Treating post-operative breathing failure with noninvasive mask ventilation versus high-velocity nasal oxygen
A Prospective, Randomized Controlled Trial Comparing Noninvasive Ventilation (NIV) Versus High-Velocity Nasal Cannula (HVNC) in the Management of Acute Post-Operative Respiratory Failure
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assiut University Academic / other |
| Locations | 1 site (Asyut, Assuit) |
| Trial ID | NCT06988111 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Asyut, Assuit
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.