Randomized Clinical Trial for Predictors of Successful Extubation of Pediatric Patients From Mechanical Ventilation Either on High Velocity Nasal Insufflation or Simple Nasal Oxygen and Comparing the Outcome

Cairo University (CU)

Status: Enrolling

Conditions: Comparing the Outcome Between High Velocity Nasal Insufflation and Simple Oxygen After Successful Weaning From Mechanical Ventilation

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07383051

MD-299-2025

Details and patient eligibility

About

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

Full description

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 reintubation within 48 hours, presence of respiratory distress or stridor post extubation, knowing mechanical ventilaton free days after extubation, time of complete weaning of oxygen support to room air and also morbidity and mortality.

Enrollment: 100 estimated patients

Sex: All

Ages: 2 months to 13 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

100 participants in 2 patient groups

Exubation of pediatric patients on High Velocity Nasal Insufflation

Experimental group

Treatment:

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 group

Treatment:

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