Comparing two nasal oxygen methods to help remove the breathing tube
High Flow Nasal Cannula vs. High Velocity Nasal Insufflation for Weaning From Mechanical Ventilation in Respiratory ICU
This test sees if high-flow nasal cannula or high-velocity nasal insufflation, compared with noninvasive ventilation, helps high-risk adults avoid needing the ventilator again after extubation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Assiut University Academic / other |
| Locations | 1 site (Asyut) |
| Trial ID | NCT07133698 on ClinicalTrials.gov |
What this trial studies
This randomized, interventional trial enrolls adults intubated for more than 24 hours who are judged high risk for extubation failure and who meet standard readiness-to-wean criteria. After successful spontaneous breathing trials and extubation, participants are randomized 1:1:1 to receive high-flow nasal cannula (HFNC), high-velocity nasal insufflation (HVNI), or noninvasive ventilation (NIV). Weaning success is defined as sustaining spontaneous breathing for 48 consecutive hours without respiratory distress and acceptable gas exchange, while failure is defined as death or reinitiation of mechanical ventilation within 48 hours. The study is conducted at Assiut University Hospital with routine ICU monitoring and standard laboratory and clinical assessments.
Who should consider this trial
Good fit: Adults aged 18 or older intubated for more than 24 hours for acute respiratory failure who are considered high risk for extubation failure and who meet standard readiness-to-wean criteria (for example, adequate oxygenation, hemodynamic stability, and successful spontaneous breathing trial) are ideal candidates.
Not a fit: Patients with unrelated central nervous system disorders, post–cardiac arrest encephalopathy, prior tracheotomy, end-organ failure, or those who do not meet readiness-to-wean criteria are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the intervention could lower reintubation rates and reduce complications, ICU length of stay, and mortality in high-risk patients after extubation.
How similar studies have performed: Small randomized trials have shown noninvasive ventilation can reduce reintubation versus standard oxygen in some high-risk groups, but large randomized comparisons directly contrasting HFNC, HVNI, and NIV are lacking.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults (≥18 years) intubated for \>24 hours due to acute respiratory failure, identified as high-risk for extubation failure AND fulfilling standard readiness-to-wean criteria (e.g., resolution of cause of intubation, adequate gas exchange \[P/F ≥150\], hemodynamic stability, spontaneous breathing trial \[SBT\] success) Exclusion Criteria: * Patients with central nervous system disorders unrelated to hypercapnic encephalopathy or hypoxemia. * Patients with post arrest encephalopathy. * Patient with previous tracheotomy. * Patients who received noninvasive ventilation without subsequent intubation. * Patients with end organ failure.
Where this trial is running
Asyut
- Assiut University hospital — Asyut, Egypt (Recruiting)
Study contacts
- Principal investigator: waleed gamal elddin, ass. prof — Assiut University
- Study coordinator: waleed gamal elddin, ass. prof
- Email: waleedgamalddin@yahoo.com
- Phone: +201006519722
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.