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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
32
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.
Aydin Obstetric and pediatrics Hospital
Aydin, Turkey (Türkiye)
Cam Sakura Research and Training Hospital
Istanbul, Turkey (Türkiye)
Acibadem University, Acibadem Altunizade Hospital
Istanbul, Turkey (Türkiye)
The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training Hospital
Izmir, Turkey (Türkiye)
Total Time Spent Under Low Cuff Pressure
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.
Time frame: 24 hours per intervention phase
Total Time Spent Under High Cuff Pressure
Total cumulative time (in hours) during which cuff pressure exceeded 25 cmH₂O in either monitoring method.
Time frame: 24 hours per intervention phase
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
The number of times the cuff pressure had to be manually corrected due to deviations from the target range during each phase.
Time frame: 24 hours per intervention phase
Total Nursing Intervention Time
Total time spent by nurses for cuff pressure monitoring and corrections, including routine checks and manual interventions.
Time frame: 24 hours per intervention phase
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