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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Page 1 of 1 (4 locations)

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)