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).
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
- Conditions the study is for
- Endotracheal Cuff, Adenoidectomy Surgery, Tonsillectomy with or Without Adenoidectomy
- 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.
Turkey (Türkiye)1 site, 1 recruiting
- 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
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.
- Conditions
- Endotracheal Cuff, Adenoidectomy Surgery, Tonsillectomy with or Without Adenoidectomy, Position Differences
- 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 group | Role | What they receive |
|---|---|---|
| Paediatric patients with adenoidectomy and/or tonsillectomy | Patients 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.
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.
- First posted10 Jan 2025
- Study start6 Jan 2025
- Primary completion6 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endotracheal CuffStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ankara Ataturk Sanatorium Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, ERBİL TÜRKSAL, Ankara Ataturk Sanatorium Training and Research Hospital
- Investigators
- Erbil Türksal, Specialist, Principal investigator, University of Health Sciences, Ankara Atatürk Sanatorium Training and Research Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Neck Hyperextension on Endotracheal Tube Cuff Pressure in Children
- ClinicalTrials.gov ID
- NCT06767696
- Acronym / sponsor ID
- 2024-BÇEK/163
- Conditions
- Endotracheal Cuff, Adenoidectomy Surgery, Tonsillectomy with or Without Adenoidectomy, Position Differences
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ankara Ataturk Sanatorium Training and Research HospitalOther government
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 6 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paediatric patients with adenoidectomy and/or tonsillectomy | – | Other: Cuff pressure measurementPatients aged 2-18 years undergoing adenoidectomy, tonsillectomy or adenotonsillectomy surgery during the study period |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (2 listed)
- Patients aged 2-18 years
- undergoing adenoidectomy, tonsillectomy or adenotonsillectomy surgery
Key exclusion criteria (4 listed)
- Patients with restricted head and neck mobility,
- patients with intraoperative complications,
- patients with previous neck surgery,
- patients with BMI > 35 kg/m2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cuff pressure measurementIntubation 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 | Other | Paediatric patients with adenoidectomy and/or tonsillectomy |
Primary outcome
cuff pressure
Time frame: intraoperative 3 times
Intubation tube cuff pressure in cmH2O at 3 different time periods with a cuff manometer (VBM Medizintechnik, GmbH, Germany)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Erbil Türksal, Specialist principal investigator
University of Health Sciences, Ankara Atatürk Sanatorium Training and Research Hospital
1 site in 1 country: see every site and its status.
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.