Cuff Pressure, Mechanical Ventilation, Pediatric Intensive Care
Conditions
Keywords
Cuff pressure, Automatic monitoring, Mechanical ventilation
Brief summary
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.
Detailed 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.
Interventions
DEVICEAutomatic 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.
Sponsors
Hamilton Medical AG
Dr. Behcet Uz Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
48 hours total (24 hours each phase, manual vs. automatic)
Eligibility
Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Time Spent Under Low Cuff Pressure | 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. |
| Total Time Spent Under High Cuff Pressure | 24 hours per intervention phase | Total cumulative time (in hours) during which cuff pressure exceeded 25 cmH₂O in either monitoring method. |
| 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Total Nursing Intervention Time | 24 hours per intervention phase | Total time spent by nurses for cuff pressure monitoring and corrections, including routine checks and manual interventions. |
Countries
Turkey (Türkiye)
Outcome results
None listed