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

Dr. Behcet Uz Children's Hospital

Status: Completed

Conditions: Cuff Pressure; Pediatric Intensive Care; Mechanical Ventilation

Treatments: Device: Automatic Cuff Pressure Control

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06965400

2024/896

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Manual Cuff Pressure Monitoring

Active Comparator group

Description:

In this arm, cuff pressure was manually measured and adjusted every 2 hours by nurses using a manometer, to maintain a target pressure between 15 and 25 cmH₂O over a 24-hour period.

Treatment:

Device: Automatic Cuff Pressure Control

Automatic Cuff Pressure Monitoring

Experimental group

Description:

In this phase, endotracheal tube cuff pressure was continuously monitored using the IntelliCuff® system (Hamilton Medical, Switzerland), which automatically adjusted the pressure to maintain it within the target range of 15-25 cmH₂O. Nurses intervened only if the system alerted due to a deviation.

Treatment:

Device: Automatic Cuff Pressure Control