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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

Not Recruiting
1-18 years
All
Phase N/A

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Overview

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.

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.

Eligibility

Inclusion Criteria:

  • 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 Criteria:

  • Patients with tracheostomy, known tracheal pathology, extubated within 48 hours, or those requiring frequent ventilator adjustments due to clinical instability were excluded.

Study details
    Cuff Pressure
    Mechanical Ventilation
    Pediatric Intensive Care

NCT06965400

Dr. Behcet Uz Children's Hospital

19 December 2025

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