A Prospective, Randomized Controlled Trial Comparing Noninvasive Ventilation (NIV) Versus High-Velocity Nasal Cannula (HVNC) in the Management of Acute Post-Operative Respiratory Failure
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Postoperative respiratory failure (PORF) remains a critical driver of morbidity, mortality, and incremental care costs in surgical populations. Traditional escalation often involves invasive mechanical ventilation, which is associated with ventilator-associated pneumonia (VAP), prolonged intensive care unit (ICU) stays, and increased resource burden.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Egypt
Assuit Univeristy
RECRUITING
Asyut
Contact Information
Primary
Ahmad M. Shaddad, MD
shaddad_ahmad@aun.edu.eg
+201111171930
Time Frame
Start Date: 2025-07-01
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 180
Treatments
Experimental: Non-invasive Ventilation group
NIV Arm~* Device: Bi-level positive airway pressure (BiPAP) via oronasal mask.~* Initial settings: inspiratory positive airway pressure (IPAP) 10 cmH₂O, expiratory positive airway pressure (EPAP) 5 cmH₂O, and fraction of inspired oxygen (FiO₂) titrated to oxygen saturation (SpO₂) ≥ 92%.~* Weaning: Decrement IPAP/EPAP by 2 cmH₂O every four hours as tolerated.
Experimental: High Velocity Nasal Cannula (HVNC) group
HVNC Arm~* Device: Heated, humidified high-flow nasal cannula (HFNC) system.~* Initial flow: 50 L/min, fraction of inspired oxygen (FiO₂) titrated to SpO₂ ≥ 92%.~* Weaning: Reduce flow by 10 L/min every 4 h as tolerated.
Related Therapeutic Areas
Sponsors
Leads: Assiut University