Predicting successful extubation in children using high-velocity nasal insufflation versus simple nasal oxygen
Predictors of Successful Extubation of Pediatric Patients From Mechanical Ventilation With or Without Post Extubation High Velocity Nasal Insufflation
This will test whether high-velocity nasal insufflation or simple nasal oxygen leads to fewer re-intubations or breathing problems after planned extubation in children ready to come off a ventilator.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 2 Months to 13 Years |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo, Cairo Governorate) |
| Trial ID | NCT07383051 on ClinicalTrials.gov |
What this trial studies
This randomized clinical comparison enrolls children aged 2 months to 13 years who have been mechanically ventilated for at least 24 hours and meet standard weaning criteria. After meeting readiness-to-extubate predictors, participants are randomized to receive either high-velocity nasal insufflation (HVNI) or simple nasal oxygen following extubation. Outcomes include need for escalation of respiratory support or re-intubation within 48 hours, presence of respiratory distress or stridor after extubation, time to complete weaning to room air, and morbidity and mortality. Patients with contraindications to HVNI or those ventilated for more than 21 days are excluded, and follow-up focuses on the immediate post-extubation period and until return to room air.
Who should consider this trial
Good fit: Children aged 2 months to 13 years weighing at least 4 kg who have been on mechanical ventilation for ≥24 hours and meet weaning criteria are ideal candidates.
Not a fit: Children not ready for weaning, those with contraindications to HVNI, or those on prolonged ventilation (>21 days) are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this could reduce re-intubation rates and shorten the time children need supplemental oxygen after extubation.
How similar studies have performed: Similar high-flow nasal therapies have shown benefit in some pediatric settings but results are mixed and direct evidence specifically comparing HVNI to simple oxygen after extubation is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 2 months and 13 years old with minimum weight 4kg * Both sexes * Patients on mechanical ventilation for at least 24 hours for any indication Exclusion Criteria: * Patients not ready for weaning from mechanical ventilation * Contraindications to use of High velocity nasal insufflation * Prolonged mechanical ventilation for more than 21 days
Where this trial is running
Cairo, Cairo Governorate
- Cairo University — Cairo, Cairo Governorate, Egypt (Recruiting)
Study contacts
- Principal investigator: Cairo University Cairo University — Cairo University
- Study coordinator: Sherin T. Fayez Ali, PICU doctor
- Email: tareksherin16@gmail.com
- Phone: +01153576707
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.