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Cuff PressureNCT06965400

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

A study of Cuff Pressure and Mechanical Ventilation, run by Dr. Behcet Uz Children's Hospital at 4 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 month to 18 yearsHealthy volunteers can take part
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
4 sitesTurkey (Türkiye)
Study dates
2 May 2025to 15 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 month to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

Turkey (Türkiye)4 sites

  • Aydin Obstetric and pediatrics Hospital

    Aydin, 09020

  • Cam Sakura Research and Training Hospital

    Istanbul, 34001

  • Acibadem University, Acibadem Altunizade Hospital

    Istanbul

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

    Izmir

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of Automatic and Manual Endotracheal Tube Cuff Pressure Monitoring in Pediatric Intensive Care Patients: A Randomized Controlled Cross-Over Study

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.

Read the 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.

Being tested
Automatic Cuff Pressure Control
Keywords
Cuff pressure, Automatic monitoring, Mechanical ventilation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Automatic Cuff Pressure ControlDevice

    Also called IntelliCuff System

    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.

Study groups in NCT06965400
Study groupRoleWhat they receive
Manual Cuff Pressure MonitoringActive comparatorIn 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.
Receives: Device: Automatic Cuff Pressure Control
Automatic Cuff Pressure MonitoringExperimentalIn 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.
Receives: Device: Automatic Cuff Pressure Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 24 hours per intervention phase

  2. Total Time Spent Under High Cuff Pressure

    Total cumulative time (in hours) during which cuff pressure exceeded 25 cmH₂O in either monitoring method.

    Measured: 24 hours per intervention phase

  3. 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.

    Measured: 24 hours per intervention phase

Secondary outcomes (1)

  1. Total Nursing Intervention Time

    Total time spent by nurses for cuff pressure monitoring and corrections, including routine checks and manual interventions.

    Measured: 24 hours per intervention phase

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2025
  2. Study start2 May 2025
  3. Primary completion1 Aug 2025
  4. Study completion15 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Model description
48 hours total (24 hours each phase, manual vs. automatic)
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06965400
Sponsor's protocol ID
2024/896
Status last verified
Nov 2025
First submitted
2 May 2025
Last updated
25 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33081526

  • 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.

    PubMed 26515515

  • 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.

    PubMed 32376293

  • 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.

    PubMed 38528475

  • 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.

    PubMed 25425705

  • 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.

    PubMed 26471790

  • Soydan E, Gokpinar EE, Karakaya O, Sevinc ZG, Ceylan G, Erbas MG, Albayrak S, Demirel O, Yay ED, Aslan K, Ozdamar NK, Turgut N, Karaarslan U, Agin H. Automated Versus Manual Endotracheal Tube Cuff Pressure Control in Mechanically Ventilated Children: A Randomized Crossover Trial. Paediatr Anaesth. 2026 Jul 16. doi: 10.1002/pan.70268. Online ahead of print.

    PubMed 42461207

Questions about this trial

What is this clinical trial studying?

A study of Cuff Pressure and Mechanical Ventilation, run by Dr. Behcet Uz Children's Hospital at 4 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Time Spent Under Low Cuff Pressure (time frame: 24 hours per intervention phase). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06965400, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.

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