Clinical trial NCT06965400: Comparison of Automatic and Manual Endotracheal Tube Cuff Pressure Monitoring in Pediatric Intensive Care Patients
Official title: Comparison of Automatic and Manual Endotracheal Tube Cuff Pressure Monitoring in Pediatric Intensive Care Patients: A Randomized Controlled Cross-Over Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cuff Pressure
Mechanical Ventilation
Pediatric Intensive Care
Keywords: Cuff pressure
Automatic monitoring
Mechanical ventilation
Lead sponsor: Dr. Behcet Uz Children's Hospital
Sponsor class: OTHER
Collaborators: name: Hamilton Medical AG
First posted: 2025-05-11
Enrollment: 32
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 48 hours total (24 hours each phase, manual vs. automatic)
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Total Time Spent Under Low Cuff Pressure
timeFrame: 24 hours per intervention phase
measure: Total Time Spent Under High Cuff Pressure
timeFrame: 24 hours per intervention phase
measure: 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
timeFrame: 24 hours per intervention phase
Secondary outcomes:
measure: Total Nursing Intervention Time
timeFrame: 24 hours per intervention phase
Other outcomes:
Locations:
city: Aydın
country: Turkey
facility: Aydin Obstetric and pediatrics Hospital
city: Istanbul
country: Turkey
facility: Cam Sakura Research and Training Hospital
city: Istanbul
country: Turkey
facility: Acibadem University, Acibadem Altunizade Hospital
city: İzmir
country: Turkey
facility: The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training Hospital
Study officials:
affiliation: Dr. Behcet Uz Children's Hospital
name: Hasan Agin, Prof.Dr.
role: STUDY_CHAIR
References:
citation: Topjian AA, Raymond TT, Atkins D, Chan M, Duff JP, Joyner BL Jr, Lasa JJ, Lavonas EJ, Levy A, Mahgoub M, Meckler GD, Roberts KE, Sutton RM, Schexnayder SM; Pediatric Basic and Advanced Life Support Collaborators. Part 4: Pediatric Basic and Advanced Life Support: 2020 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2020 Oct 20;142(16_suppl_2):S469-S523. doi: 10.1161/CIR.0000000000000901. Epub 2020 Oct 21. No abstract available.
citation: Vottier G, Matrot B, Jones P, Dauger S. A cross-over study of continuous tracheal cuff pressure monitoring in critically-ill children. Intensive Care Med. 2016 Jan;42(1):132-3. doi: 10.1007/s00134-015-4103-8. Epub 2015 Oct 29. No abstract available.
citation: Dauvergne JE, Geffray AL, Asehnoune K, Rozec B, Lakhal K. Automatic regulation of the endotracheal tube cuff pressure with a portable elastomeric device. A randomised controlled study. Anaesth Crit Care Pain Med. 2020 Jun;39(3):435-441. doi: 10.1016/j.accpm.2020.04.007. Epub 2020 May 4.
citation: Zhu G, Wang X, Cao X, Yang C, Wang B, Ang Y, Duan M. The effect of different endotracheal tube cuff pressure monitoring systems on postoperative sore throat in patients undergoing tracheal intubation: a randomized clinical trial. BMC Anesthesiol. 2024 Mar 25;24(1):115. doi: 10.1186/s12871-024-02499-5.
citation: Chenelle CT, Oto J, Sulemanji D, Fisher DF, Kacmarek RM. Evaluation of an automated endotracheal tube cuff controller during simulated mechanical ventilation. Respir Care. 2015 Feb;60(2):183-90. doi: 10.4187/respcare.03387. Epub 2014 Nov 25.
citation: Alzahrani AR, Al Abbasi S, Abahoussin OK, Al Shehri TO, Al-Dorzi HM, Tamim HM, Sadat M, Arabi YM. Prevalence and predictors of out-of-range cuff pressure of endotracheal and tracheostomy tubes: a prospective cohort study in mechanically ventilated patients. BMC Anesthesiol. 2015 Oct 15;15:147. doi: 10.1186/s12871-015-0132-7.