A Randomized Clinical Trial for Predictors of Successful Extubation of Pediatric Patients With or Without High Velocity Nasal Insufflation

NCT07383051 | Recruiting

• 1 other identifier: MD-299-2025
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized clinical trial about predictors of successful extubation of pediatric patients from mechanical ventilation either on High Velocity Nasal Insufflation or simple nasal oxygen and comparing the outcome

Conditions

High Velocity Nasal Insufflation; Simple Oxygen; Weaning Criteria

Outcome Measures

Primary Outcomes (1)

• comparing the need for reintubation within 48 hours afterr extubation using High Velocity Nasal Insufflation versus simple oxygen

  Successful extubation with no need for reintubation within 48 hours among pediatric ICU patients in those using High Velocity Nasal Insufflation versus simple oxygen

  48 hours

Study Arms (2)

Exubation of pediatric patients on High Velocity Nasal Insufflation

EXPERIMENTAL

Device: Comparing the outcome of pediatric patients after successful weaning on either High Velocity Nasal Insufflation or simple oxygen; Device: comparing High Velocity Nasal Insufflation to simple oxygen after successful weaning of pediatric patients

Exubation of pediatric patients on simple oxygen

ACTIVE COMPARATOR

Device: Comparing the outcome of pediatric patients after successful weaning on either High Velocity Nasal Insufflation or simple oxygen; Device: comparing High Velocity Nasal Insufflation to simple oxygen after successful weaning of pediatric patients

Interventions

comparing High Velocity Nasal Insufflation to simple oxygen after successful weaning of pediatric patients DEVICE

A randomized clinical study is comparing between extubation on High Velocity Nasal Insufflation or simple nasal Oxygen ensuring that all patients had successful weaning predictors before extubation and comparing the outcome whether patient needed upgrading of oxygen support or re-intubation within 48 hours, presence of respiratory distress or stridor post extubation, time of complete weaning of oxygen support to room air and also morbidity and mortality.

Exubation of pediatric patients on High Velocity Nasal Insufflation; Exubation of pediatric patients on simple oxygen

Comparing the outcome of pediatric patients after successful weaning on either High Velocity Nasal Insufflation or simple oxygen DEVICE

A randomized clinical study is comparing between extubation on High Velocity Nasal Insufflation or simple nasal Oxygen ensuring that all patients had successful weaning predictors before extubation and comparing the outcome whether patient needed upgrading of oxygen support or re-intubation within 48 hours, presence of respiratory distress or stridor post extubation, time of complete weaning of oxygen support to room air and also morbidity and mortality.

Exubation of pediatric patients on High Velocity Nasal Insufflation; Exubation of pediatric patients on simple oxygen

Eligibility Criteria

• Age: 2 Months - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Patients not ready for weaning from mechanical ventilation
• Contraindications to use of High velocity nasal insufflation
• Prolonged mechanical ventilation for more than 21 days

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Cairo Governorate, Egypt

RECRUITING

Study Officials

• Cairo University Cairo University

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sherin T. Fayez Ali, PICU doctor

CONTACT

+01153576707; tareksherin16@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cairo University

Model Details: comparing the outcome between High Velocity Nasal Insufflation and simple oxygen after successful weaning from mechanical ventilation

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 3, 2026
• Study Start: September 20, 2025
• Primary Completion (Estimated): September 20, 2026
• Study Completion (Estimated): September 20, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)