NCT06965400

Comparison of Automatic and Manual Endotracheal Tube Cuff Pressure Monitoring in Pediatric Intensive Care Patients

Comparison of Automatic and Manual Endotracheal Tube Cuff Pressure Monitoring in Pediatric Intensive Care Patients: A Randomized Controlled Cross-Over Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Dr. Behcet Uz Children's Hospital · Academic / Other
• Sex: All
• Age: 1 Month – 18 Years
• Healthy volunteers: Accepted

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. The study evaluates the frequency and duration of cuff pressure deviations outside the recommended range (15-25 cmH₂O) and assesses the impact on nursing workload.

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 to compare the effectiveness and safety of continuous automatic cuff pressure monitoring using the IntelliCuff® system versus standard manual cuff pressure monitoring performed by nurses every 2 hours. Patients aged between 1 month and 18 years requiring invasive mechanical ventilation for at least 48 hours participated in a cross-over study at two tertiary pediatric intensive care units. Each patient underwent two consecutive 24-hour monitoring periods: one with automatic cuff pressure monitoring and another with manual monitoring. Data collected included the frequency and total duration of low (\<15 cmH₂O) and high (\>25 cmH₂O) pressure episodes, number of manual corrections required, and total nursing intervention time. This study aims to determine whether automatic monitoring provides better control of cuff pressure, reduces the frequency of cuff-related complications, and decreases nursing workload compared to manual monitoring.

Conditions

• Cuff Pressure
• Mechanical Ventilation
• Pediatric Intensive Care

Interventions

Type	Name	Description
DEVICE	Automatic Cuff Pressure Control	he IntelliCuff® system (Hamilton Medical, Switzerland) continuously monitored and automatically adjusted cuff pressure to keep it within the target range of 15-25 cmH₂O. Manual intervention was only required upon system alert.

Timeline

• Start date: 2025-05-02
• Primary completion: 2025-08-01
• Completion: 2025-08-15
• First posted: 2025-05-11
• Last updated: 2025-11-25

Locations

4 sites across 1 country: Turkey (Türkiye)