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Endotracheal CuffNCT06767696

Effect of Neck Hyperextension on Endotracheal Tube Cuff Pressure in Children

An observational study of Endotracheal Cuff and Adenoidectomy Surgery, run by Ankara Ataturk Sanatorium Training and Research Hospital at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 2 to 18 yearsHealthy volunteers can take part
What is being tested?
Cuff pressure measurement
How many people
120 participants
Where
1 siteTurkey (Türkiye)
Study dates
6 Jan 2025to 31 Dec 2025
Phase
Observational
Are there results?
Not yet: the study is under way

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 2 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

ERBİL TÜRKSAL, Specialist contact

530 228 1319 ext. +90

drerbilturksal@hotmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • University of Health Sciences, Ankara Atatürk Sanatorium Training and Research Hospital

    Ankara, Keçiören, 06290

    Erbil Türksal, Specialist, +90 530 228 1319, drerbilturksal@hotmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Neck Hyperextension on Endotracheal Tube Cuff Pressure in Children

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.

Read more

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.

Being tested
Cuff pressure measurement

What participants receive

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

  • Cuff pressure measurementOther

    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

Study groups in NCT06767696
Study groupRoleWhat they receive
Paediatric patients with adenoidectomy and/or tonsillectomyPatients aged 2-18 years undergoing adenoidectomy, tonsillectomy or adenotonsillectomy surgery during the study period
Receives: Other: Cuff pressure measurement

What is being measured

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

  1. cuff pressure

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

    Measured: intraoperative 3 times

Timeline

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

  1. First posted10 Jan 2025
  2. Study start6 Jan 2025
  3. Primary completion6 Jun 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06767696
Sponsor's protocol ID
2024-BÇEK/163
Status last verified
Jan 2025
First submitted
6 Jan 2025
Last updated
7 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Endotracheal Cuff and Adenoidectomy Surgery, run by Ankara Ataturk Sanatorium Training and Research Hospital at 1 site 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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

This study is still under way. Results are not available in the source record yet.

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

Contact ERBİL TÜRKSAL, Specialist (530 228 1319 ext. +90, drerbilturksal@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

cuff pressure (time frame: intraoperative 3 times). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 7 Feb 2025.

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