A Randomized Clinical Trial for Predictors of Successful Extubation of Pediatric Patients With or Without High Velocity Nasal Insufflation
Predictors of Successful Extubation of Pediatric Patients From Mechanical Ventilation With or Without Post Extubation High Velocity Nasal Insufflation
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
Study Overview
Status
Detailed 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 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sherin T. Fayez Ali, PICU doctor
- Phone Number: +01153576707
- Email: tareksherin16@gmail.com
Study Locations
-
-
Cairo Governorate
-
Cairo, Cairo Governorate, Egypt
- Recruiting
- Cairo University
-
Contact:
- Cairo University Cairo University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exubation of pediatric patients on High Velocity Nasal Insufflation
|
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. 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. |
|
Active Comparator: Exubation of pediatric patients on simple oxygen
|
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. 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
comparing the need for reintubation within 48 hours afterr extubation using High Velocity Nasal Insufflation versus simple oxygen
Time Frame: 48 hours
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Cairo University Cairo University, Cairo University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MD-299-2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
No individual participant data will be shared as per the individual signed consent to participate.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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