An interventional study of BIPAP and Vapotherm in Respiratory Failure Without Hypercapnia, Respiratory Failure With Hypercapnia and Postoperative Respiratory Complication, sponsored by Assiut University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Assiut University · Not applicable, Interventional, and Supportive care
Among 14 studies in Respiratory Insufficiency by Assiut University — 9 open to participants now, 9 under way, none of them phase 3. Respiratory Insufficiency · Assiut University.
Among the 14 studies in Respiratory Insufficiency by Assiut University, this one is one of 2 that started in 2025, is one of 7 with no phase, and was the 8th registered.
1,369 studies on the registry are indexed under Respiratory Insufficiency; 264 are open to participants now.
This study's planned enrollment of 180 is above the median of 60 across 860 interventional studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →9 of the 14 studies in Respiratory Insufficiency by Assiut University are open now, in 1 country. Each count lists the studies.
Of the 178 Respiratory Insufficiency studies recruiting now, 134 (75%) set no upper age limit and 18 (10%) stop at 75 or younger; 21 take children under 18; 19 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →14 studies; the count open now beside each. This study's row is marked.
First in 2016; this study’s year is marked. 2 started in 2025.
Median enrollment 100 across the 7 interventional studies, 120 across the 7 observational. Of the 1 that completed or were terminated, 0 (0%) have results posted.
Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
7 of the studies in Respiratory Insufficiency by Assiut University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06988111Assiut UniversityManagement of Post-operative Respiratory Failure by Using NIV and High Velocity Nasal Insufflation (HVNI) | 2026-11-01 |
| NCT07713238Assiut UniversityHumidification Effects on Airway Complications and Clinical Outcomes in Trauma ICU Patients on Mechanical Ventilation | 2026-12-12 |
| NCT06715644Assiut UniversityROX Index Versus MROX Index to Predict Treatment Outcome for High Flow Nasal Cannula And/or Noninvasive Ventilation in Patients with Respiratory Failure | 2027-01-01 |
| NCT07542093Assiut UniversityBedside Lung Ultrasound to Monitor Lung Recruitment in Obese Patients | 2027-05 |
| NCT07821632Assiut UniversityPredictors of Prolonged Mechanical Ventilation in Preterm Infants | 2027-09-25 |
Among the 14 studies in Respiratory Insufficiency by Assiut University, from their registry updates:
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.
Noninvasive ventilation (NIV) and high-flow nasal cannula (HFNC) have both been shown to improve oxygen levels effectively and reduce the need for reintubation in various patient groups. However, head-to-head data in patients with obstructive or restrictive pulmonary function (PORF) are scarce.
This protocol employs a robust and scalable design to generate high-quality evidence, empower perioperative stakeholders, and optimize patient-centric respiratory strategies. We hypothesize that NIV will reduce 72-hour reintubation rates compared to HFNC, translating into shorter ICU stays and lower costs.
Methodology \& Operational Workflow
ABGs and fraction of inspired oxygen (FIO2) at 1 hour, 6 hours, and 24 hours. Comfort scores every six hours. Record interface-related adverse events.
- Escalation Criteria The patient exhibits persistent partial arterial oxygen pressure/fraction of inspired oxygen ratio (PaO2/FiO2) levels of less than 100, even at maximal settings.
Hemodynamic instability occurs due to the use of new-onset vasopressors. Deterioration leading to invasive ventilation → classified as "reintubation."
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Device: BIPAP
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.
Device: Vapotherm
The second arm (NIV group) will be managed by BIPAP device for post-operative respiratory failure
The first arm (HVNC group) will be managed by Vapotherm device for post-operative respiratory failure
Also known as: High-velocity nasal insufflation, High velocity nasal cannula
Weaning success
The primary outcome will be comparing the weaning success (in days) for both arms of the study group. This will be accessed after 48 hours and on a daily basis until the weaning criteria are met or for 28 days.
Time frame: At 48 hours and then daily for 28 days.
Plan to share: Yes — De-identified individual participant data supporting the primary and secondary outcomes, along with accompanying data dictionaries and the statistical analysis plan, will be made available by Assiut University's institutional data-sharing policies.
Supporting information: Study protocol, Statistical analysis plan
Time frame: 6-36 months after publication.
Access criteria: Data will be accessible 6-36 months after publication to qualified researchers upon submission of a study proposal, approval by the University Research Ethics Committee, and execution of a data-use agreement.
No publications or documents are linked to this record.
Started Dec 2025 (actual). Primary completion is estimated for Nov 2026, 11 months after the start.
Of 359 non-industry interventional studies with no phase under Respiratory Insufficiency, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 47. This study's planned 11 months is below that.
Counting every sponsor, half of 375 studies reached it within 24 months; a quarter within 10 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
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