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NCT Number: NCT06965400

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

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.

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Key information

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aydin Obstetric and pediatrics Hospital, Aydin, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Automatic Cuff Pressure Control

Device

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.

Other names: IntelliCuff System

Primary outcomes

  1. Total Time Spent Under Low Cuff Pressure

    Time frame: 24 hours per intervention phase

    TTotal cumulative time (in hours) during which the endotracheal tube cuff pressure remained below 15 cmH₂O throughout the 24-hour monitoring period in each study phase.

  2. Total Time Spent Under High Cuff Pressure

    Time frame: 24 hours per intervention phase

    Total cumulative time (in hours) during which cuff pressure exceeded 25 cmH₂O in either monitoring method.

  3. Number of Manual Corrections Required Number of Manual Corrections Required Number of Manual Corrections Required Number of Manual Corrections Required Number of Manual Corrections Required

    Time frame: 24 hours per intervention phase

    The number of times the cuff pressure had to be manually corrected due to deviations from the target range during each phase.

Secondary outcomes

  1. Total Nursing Intervention Time

    Time frame: 24 hours per intervention phase

    Total time spent by nurses for cuff pressure monitoring and corrections, including routine checks and manual interventions.

Sponsors and collaborators

Lead sponsor

Dr. Behcet Uz Children's Hospital

Other

Collaborators

  • Hamilton Medical AG

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 11, 2025
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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