Status:
COMPLETED
Comparison of Automatic and Manual Endotracheal Tube Cuff Pressure Monitoring in Pediatric Intensive Care Patients
Lead Sponsor:
Dr. Behcet Uz Children's Hospital
Collaborating Sponsors:
Hamilton Medical AG
Conditions:
Cuff Pressure
Mechanical Ventilation
Eligibility:
All Genders
1-18 years
Phase:
NA
Brief Summary
This prospective, randomized controlled cross-over study compares automatic (IntelliCuff®) and manual methods of endotracheal tube cuff pressure (CP) monitoring in pediatric intensive care patients. T...
Detailed Description
Optimal cuff pressure management in pediatric patients undergoing mechanical ventilation is critical to prevent complications such as aspiration pneumonia or tracheal injuries. This study was designed...
Eligibility Criteria
Inclusion
- Patients aged between 1 month and 18 years who were intubated with a cuffed endotracheal tube and expected to require invasive mechanical ventilation for at least 48 hours were eligible for inclusion
Exclusion
- Patients with tracheostomy, known tracheal pathology, extubated within 48 hours, or those requiring frequent ventilator adjustments due to clinical instability were excluded.
Key Trial Info
Start Date :
May 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2025
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06965400
Start Date
May 2 2025
End Date
August 15 2025
Last Update
November 25 2025
Active Locations (4)
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1
Aydin Obstetric and pediatrics Hospital
Aydin, Turkey (Türkiye), 09020
2
Cam Sakura Research and Training Hospital
Istanbul, Turkey (Türkiye), 34001
3
Acibadem University, Acibadem Altunizade Hospital
Istanbul, Turkey (Türkiye)
4
The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training Hospital
Izmir, Turkey (Türkiye)