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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-02

Study Completion Date

2025-08-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison of the Frequency of Ventilator-Associated Pneumonia in Intubated Patients Followed Up With Automatic Cuff Pressure Controller and Manual Cuff Pressure Controller in Pediatric Intensive Care

NCT05918172

Ventilator-associated Pneumonia

UNKNOWN

Cuff Pressure Regulation Apparatus for Tracheal Intubation in Children

NCT04413318

Cuff Overinflation Cuff Underinflation

COMPLETED NA

Effects of Endotracheal Tube Cuff Pressure Control on Microaspiration of Gastric Contents

NCT04061083

Mechanical Ventilation Complication Ventilator Associated Pneumonia Nursing Caries +1 more

COMPLETED NA

Measuring Lung Pressures in Critically Ill Children Who Are on Mechanical Ventilation

NCT02354365

Transpulmonary Pressure Pressure.Rate Product Guide to Mechanical Ventilator Management +1 more

UNKNOWN

Minimal Occlusive Pressure With Cuffed ETTs: The Effect of 3 Different Sizes of cETT on Intracuff Pressure in Children

NCT04061629

Surgical Procedure, Unspecified

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Cuff Pressure Mechanical Ventilation Pediatric Intensive Care

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

48 hours total (24 hours each phase, manual vs. automatic)

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Manual Cuff Pressure Monitoring

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.

Group Type ACTIVE_COMPARATOR

Automatic Cuff Pressure Control

Intervention Type 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.

Automatic Cuff Pressure Monitoring

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.

Group Type EXPERIMENTAL

Automatic Cuff Pressure Control

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

IntelliCuff System

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes