CClinicalTrials.gg
RecruitingNCT06767696Updated Feb 7, 2025

Effect of Neck Hyperextension on Endotracheal Tube Cuff Pressure in Children

An observational study in Endotracheal Cuff, Adenoidectomy Surgery and Tonsillectomy with or Without Adenoidectomy, sponsored by Ankara Ataturk Sanatorium Training and Research Hospital. Recruiting at 1 site in Turkey. Open to participants aged 2 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-07.

Sponsored by Ankara Ataturk Sanatorium Training and Research Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 4 months ago, but the record still lists the study as recruiting.
  • Started Jan 2025; still recruiting 1 year 9 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
120
Ages
2 Years to 18 Years
Sex
All
01

Study summary

Introduction: Patients undergoing surgery under general anaesthesia are frequently intubated with an endotracheal tube (ETT). The safety margin of ETT cuff pressure is between 20-30 cmH2O. Inadequately inflated cuff (\<20 cmH2O) may cause secretions in the mouth, foreign bodies, bleeding due to surgery to escape into the trachea and/or air leakage. As a result of air leakage, the effect of mechanical ventilation decreases, end-tidal CO2 measurement cannot be performed accurately, and inhalation anaesthetics leak into the operating room. An overinflated cuff (>30 cmH2O) may affect tracheal mucosa blood flow. This may result in tracheal stenosis, tracheoesophageal fistula or tracheal rupture. There may be significant changes in cuff pressure during endotracheal intubation because cuff pressure can be affected by changes in head and neck position. Due to all these situations, controlling ETT cuff pressure is very important for patient health and safety.

For ETT cuff pressure control; manual palpation of the pilot balloon, listening for the disappearance of an audible air leak, inflating the cuff with minimal occlusive pressure to a peak inflation pressure of 20-22 cmH2O during positive pressure ventilation, inflating the cuff until the airway is closed by maintaining a continuous positive airway pressure of 20 cmH2O, or cuff manometers are commonly used applications. Although cuff manometers can be used to guide the monitoring of cuff pressure, their use and availability is not mandatory in many institutions around the world (due to the large number of anaesthetic areas, it is not possible to have a manometer everywhere). Therefore, in anaesthetic practice, cuff pressure is monitored manually or using a manometer at regular intervals during the operation.

Aim/Hypothesis:

H0: Endotracheal tube cuff pressure does not change with hyperextension position given to the neck during adenoidectomy, tonsillectomy or adenotonsillectomy surgery.

H1: Endotracheal tube cuff pressure changes with hyperextension position given to the neck during adenoidectomy, tonsillectomy or adenotonsillectomy surgery.

Material-Methods: The study will include patients between the ages of 2-18 years who will undergo adenoidectomy, tonsillectomy or adenotonsillectomy after obtaining informed consent from their parents. Routine practice will be followed for induction and maintenance of anaesthesia. Patients monitored in the operating room according to the standard American Society of Anesthesiologists (ASA) protocol will be orotracheally intubated with an ETT of appropriate internal diameter after induction of anaesthesia by the anaesthesiologist responsible for the patient. After the tube placement of the intubated patients is confirmed by the responsible anaesthesiologist, the ETT cuff will be measured and recorded by the responsible investigator with a cuff manometer (VBM Medizintechnik, GmbH, Germany) while the head and neck are in the neutral position (T0). When the patients are given the head-neck hyperextension position in which the surgery will be performed by the surgical team responsible for the patient's surgery, the pressure measurements will be repeated by the responsible investigator (T1). At the end of the operation, when the head and neck are returned to the neutral position, the tubular cuff pressure will be measured by the responsible investigator for the last time (T2).

Patients between 2-18 years of age who underwent adenoidectomy, tonsillectomy or adenotonsillectomy surgery will be included in the study. Patients with head and neck mobility restriction, patients who have had neck surgery before, and patients with body mass index (BMI) > 35 kg/m2 will be excluded from the study.

02

Conditions studied

  • Endotracheal Cuff
  • Adenoidectomy Surgery
  • Tonsillectomy with or Without Adenoidectomy
  • Position Differences
03

In context

Lead sponsor

Ankara Ataturk Sanatorium Training and Research Hospital is the lead sponsor of 32 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Sample size was calculated using G*Power software, version 3.1.9.6. The effect size used in the calculation was derived from the study conducted by Kako et al. in which head position and cuff pressure changes were compared in the paediatric age group. Kako et al. reported that the cuff pressure was 18.3 ± 6.6 cmH2O in the neutral position and 20.9 ± 10.5 cmH2O when the head was extended (effect size 0.23). According to these data, a minimum sample size of 120 patients with a type-1 error level of 0.05, an effect size of 0.23 and a working power of 80% was calculated to determine the difference in cuff pressure with head position.

Inclusion criteria

  • Patients aged 2-18 years
  • undergoing adenoidectomy, tonsillectomy or adenotonsillectomy surgery

Exclusion criteria

Exclusion Criteria:

  • Patients with restricted head and neck mobility,
  • patients with intraoperative complications,
  • patients with previous neck surgery,
  • patients with BMI > 35 kg/m2
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
120 participants (estimated)
Patient registry
No

Groups and cohorts

  • Paediatric patients with adenoidectomy and/or tonsillectomy

    Patients aged 2-18 years undergoing adenoidectomy, tonsillectomy or adenotonsillectomy surgery during the study period

    Other: Cuff pressure measurement

Interventions

  • OtherCuff pressure measurement

    Intubation tube cuff pressure in cmH2O at 3 different time periods with a cuff manometer (VBM Medizintechnik, GmbH, Germany) Time periods: Cuff pressure value measured in neutral position after intubation (cmH2O) - T0 Cuff pressure measurement value after hyperextension (cmH2O) - T1 Cuff pressure measurement value in neutral position after surgical procedure (cmH2O) - T2

06

What researchers measure

Primary outcomes

  1. cuff pressure

    Intubation tube cuff pressure in cmH2O at 3 different time periods with a cuff manometer (VBM Medizintechnik, GmbH, Germany)

    Time frame: intraoperative 3 times

07

Study locations

1 of 1 sites recruiting
  • University of Health Sciences, Ankara Atatürk Sanatorium Training and Research Hospital
    Ankara, Keçiören 06290, Turkey
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06767696
Lead sponsor
Ankara Ataturk Sanatorium Training and Research Hospital
Responsible party
ERBİL TÜRKSAL (Medical Doctor, Ankara Ataturk Sanatorium Training and Research Hospital) — Principal investigator
First posted
Jan 10, 2025
Start date
Jan 6, 2025
Primary completion
Jun 6, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Feb 7, 2025

Study contacts

ERBİL TÜRKSAL, Specialist
Contact
drerbilturksal@hotmail.com
530 228 1319 ext. +90
Erbil Türksal, Specialist
principal investigator · University of Health Sciences, Ankara Atatürk Sanatorium Training and Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion