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

NCT06965400 | Completed

• 1 other identifier: 2024/896
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 4

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.

Conditions

Cuff Pressure; Mechanical Ventilation; Pediatric Intensive Care

Keywords

Cuff pressure; Automatic monitoring; Mechanical ventilation

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  24 hours per intervention phase

Secondary Outcomes (1)

• Total Nursing Intervention Time

  24 hours per intervention phase

Study Arms (2)

Manual Cuff Pressure Monitoring

ACTIVE COMPARATOR

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.

Device: Automatic Cuff Pressure Control

Automatic Cuff Pressure Monitoring

EXPERIMENTAL

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.

Device: Automatic Cuff Pressure Control

Interventions

Automatic Cuff Pressure Control 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.

Also known as: IntelliCuff System

Automatic Cuff Pressure Monitoring; Manual Cuff Pressure Monitoring

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may not qualify if:

• Patients with tracheostomy, known tracheal pathology, extubated within 48 hours, or those requiring frequent ventilator adjustments due to clinical instability were excluded.

Sponsors & Collaborators

• Dr. Behcet Uz Children's Hospital: lead
• Hamilton Medical AG: collaborator

Study Sites (4)

Aydin Obstetric and pediatrics Hospital

Aydin, 09020, Turkey (Türkiye)

Location

Cam Sakura Research and Training Hospital

Istanbul, 34001, Turkey (Türkiye)

Location

Acibadem University, Acibadem Altunizade Hospital

Istanbul, Turkey (Türkiye)

Location

The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training Hospital

Izmir, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 33081526 BACKGROUND

• 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.

  PMID: 26515515 RESULT

• 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.

  PMID: 32376293 RESULT

• 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.

  PMID: 38528475 RESULT

• 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.

  PMID: 25425705 RESULT

• 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.

  PMID: 26471790 RESULT

Study Officials

• Hasan Agin, Prof.Dr.

  Dr. Behcet Uz Children's Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr

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

Study Record Dates

• First Submitted: May 2, 2025
• First Posted: May 11, 2025
• Study Start: May 2, 2025
• Primary Completion: August 1, 2025
• Study Completion: August 15, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (4)