IntubationNCT06142149
The Optimal Endotracheal Tube Cuff Position in Pediatric Patients
A study testing ultrasonographic evaluation in people with Intubation, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
A. The hypothesis of this study is "Airway ultrasound will be superior to the conventional methods of auscultation and palpation in confirming proper positioning of the endotracheal tube in children undergoing endotracheal intubation with an endotracheal tube with cuff". B. Read more about this study
- Who is it for?
- Ages 6 months to 7 years
- Conditions the study is for
- Intubation
- What is being tested?
- ultrasonographic evaluation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Nov 2023to 31 Mar 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 6 months to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients ages 6 months to 7 years who are scheduled to have an endotracheal tube inserted for facial or intraoral surgery.
Who cannot join
- When difficult intubation is anticipated
- If the patient has deformities such as facial asymmetry due to congenital causes such as genetic diseases or acquired causes such as accidents.
- If the patient or guardian does not agree to participate in the study.
- Other cases deemed unsuitable by the researcher
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Children's Hospital
Seoul, 03080
Eun-Hee Kim, M.D., Ph.D., +82-2-2072-3664, beloveun@snu.ac.kr
About this study
Official title: Ultrasound Versus Palpation to Find Optimal Endotracheal Tube Cuff Position in Pediatric Patients Receiving Head and Neck Surgery: Randomized Controlled Trial
- The hypothesis of this study is "Airway ultrasound will be superior to the conventional methods of auscultation and palpation in confirming proper positioning of the endotracheal tube in children undergoing endotracheal intubation with an endotracheal tube with cuff".
- The purpose of this study is to determine the utility of airway ultrasound in confirming proper positioning of the endotracheal tube.
- In addition, we would like to suggest what criteria should be used when using airway ultrasound to determine the fixed position of an endotracheal tube.
Read the detailed description
- Obtain consent from the guardian of the target patient before surgery and perform randomization.
- After entering the operating room, attach equipment for electrocardiogram, non-invasive blood pressure, peripheral oxygen saturation, anesthesia depth monitoring, and neuromuscular blockade monitoring.
- Prepare the endotracheal tube according to the patient's age. 6 months to 18 months: internal diameter 3.5 18 months to 2 years: internal diameter 3.5 or 4.0 2-4 years: internal diameter 4.0 4 to 5 years: internal diameter 4.5 5 years and older: Age/4 + 3.5
- When sufficient neuromuscular blockade is achieved after infusion of neuromuscular blocking agents, after inserting the endotracheal tube, check the position of the endotracheal tube according to the assigned group, fix the endotracheal tube in consideration of changes in posture during surgery, and record its depth. Ultrasound group A. During tracheal intubation using a video laryngoscope, the endotracheal tube is stopped when the endotracheal tube cuff passes through the vocal cord.
- Use ultrasound to check the position of the endotracheal tube cuff, check its movement according to the surgical position, and position the cuff according to the size of the endotracheal tube as follows.
- internal diameter 3.5, internal diameter 4.0: The cuff is positioned 0.5 cm below the lower margin of the cricoid cartilage.
- internal diameter 4.5, internal diameter 5.0: The cuff is positioned 1 cm below the lower margin of the cricoid cartilage.
- In the final position, check for bilateral lung movement (lung sliding sign) using lung ultrasound.
- Record the depth of fixation of the endotracheal tube. Conventional Group A. During tracheal intubation with video laryngoscope, stop the endotracheal tube when the cuff of the endotracheal tube passes through the vocal cords, and confirm that the cuff of the endotracheal tube is palpable at the suprasternal notch.
- Adjust the position of the endotracheal tube to account for movement in the surgical position and confirm that the endotracheal tube cuff is palpable at the suprasternal notch in the final position for surgery.
- Confirm that bilateral lung sounds are audible through auscultation and secure the endotracheal tube.
- Record the depth of endotracheal tube placement.
- After the end of surgery and before awakening the patient, check the position of the endotracheal tube cuff using ultrasound.
Record how far the proximal margin of the endotracheal tube cuff is from the lower margin of the cricoid and how it relates to surrounding structures (1st tracheal ring, 2nd tracheal ring, 3rd tracheal ring, below the 3rd tracheal ring, above the cricoid level).
Check the movement of both lungs (sliding sign) using lung ultrasound.
- Conditions
- Intubation
- Being tested
- ultrasonographic evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonographic evaluationProcedure or surgery
Screen the front of neck using ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound group | Experimental | Use ultrasound to check the position of the endotracheal tube cuff, check its movement according to the surgical position, and position the cuff according to the size of the endotracheal tube. Receives: Procedure: ultrasonographic evaluation |
| Conventional group | No intervention | Adjust the position of the endotracheal tube to account for movement in the surgical position and confirm that the endotracheal tube air sac is palpable at the suprasternal notch in the final position for surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of the patients whose cuff is optimally located.
Percentage of patients with endotracheal tube cuff located below the cricoid lower margin and at a depth that allows movement of both lungs, as confirmed by postoperative ultrasound.
Measured: at the end of the surgery
Secondary outcomes (4)
Differences in final endotracheal tube fixation depth in the two groups
difference between tube fixation depth (cm)
Measured: at the end of induction of anesthesia
Incidence of respiratory events
endobronchial intubation, incidental extubation, laryngospasm, bronchospasm, desaturation, airway obstruction, stridor
Measured: throughout the surgery
proportion of final cuff position
Above cricoid / 1st ring / 2nd ring / 3rd ring / below 3rd ring of trachea
Measured: at the end of the surgery
incidence of postoperative complication
laryngospasm, bronchospasm, desaturation, airway obstruction, stridor, severe coughing
Measured: at postanesthetic care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start16 Nov 2023
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IntubationStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eun-hee Kim, Seoul National University Hospital
- Investigators
- Eun-Hee Kim, M.D., Ph.D., Study chair, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06142149
- Sponsor's protocol ID
- 2308-112-1459
- Status last verified
- Nov 2023
- First submitted
- 15 Nov 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Limited availability to those deemed appropriate by the researcher.
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Versus Palpation to Find Optimal Endotracheal Tube Cuff Position in Pediatric Patients Receiving Head and Neck Surgery: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06142149
- Acronym / sponsor ID
- 2308-112-1459
- Conditions
- Intubation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 16 Nov 2023 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 21 Nov 2023 (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.
- The hypothesis of this study is "Airway ultrasound will be superior to the conventional methods of auscultation and palpation in confirming proper positioning of the endotracheal tube in children undergoing endotracheal intubation with an endotracheal tube with cuff".
- The purpose of this study is to determine the utility of airway ultrasound in confirming proper positioning of the endotracheal tube.
- In addition, we would like to suggest what criteria should be used when using airway ultrasound to determine the fixed position of an endotracheal tube.
Detailed description
- Obtain consent from the guardian of the target patient before surgery and perform randomization.
- After entering the operating room, attach equipment for electrocardiogram, non-invasive blood pressure, peripheral oxygen saturation, anesthesia depth monitoring, and neuromuscular blockade monitoring.
- Prepare the endotracheal tube according to the patient's age. 6 months to 18 months: internal diameter 3.5 18 months to 2 years: internal diameter 3.5 or 4.0 2-4 years: internal diameter 4.0 4 to 5 years: internal diameter 4.5 5 years and older: Age/4 + 3.5
- When sufficient neuromuscular blockade is achieved after infusion of neuromuscular blocking agents, after inserting the endotracheal tube, check the position of the endotracheal tube according to the assigned group, fix the endotracheal tube in consideration of changes in posture during surgery, and record its depth. Ultrasound group A. During tracheal intubation using a video laryngoscope, the endotracheal tube is stopped when the endotracheal tube cuff passes through the vocal cord.
- Use ultrasound to check the position of the endotracheal tube cuff, check its movement according to the surgical position, and position the cuff according to the size of the endotracheal tube as follows.
- internal diameter 3.5, internal diameter 4.0: The cuff is positioned 0.5 cm below the lower margin of the cricoid cartilage.
- internal diameter 4.5, internal diameter 5.0: The cuff is positioned 1 cm below the lower margin of the cricoid cartilage.
- In the final position, check for bilateral lung movement (lung sliding sign) using lung ultrasound.
- Record the depth of fixation of the endotracheal tube. Conventional Group A. During tracheal intubation with video laryngoscope, stop the endotracheal tube when the cuff of the endotracheal tube passes through the vocal cords, and confirm that the cuff of the endotracheal tube is palpable at the suprasternal notch.
- Adjust the position of the endotracheal tube to account for movement in the surgical position and confirm that the endotracheal tube cuff is palpable at the suprasternal notch in the final position for surgery.
- Confirm that bilateral lung sounds are audible through auscultation and secure the endotracheal tube.
- Record the depth of endotracheal tube placement.
- After the end of surgery and before awakening the patient, check the position of the endotracheal tube cuff using ultrasound.
Record how far the proximal margin of the endotracheal tube cuff is from the lower margin of the cricoid and how it relates to surrounding structures (1st tracheal ring, 2nd tracheal ring, 3rd tracheal ring, below the 3rd tracheal ring, above the cricoid level).
Check the movement of both lungs (sliding sign) using lung ultrasound.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound group | Experimental | Procedure: ultrasonographic evaluationUse ultrasound to check the position of the endotracheal tube cuff, check its movement according to the surgical position, and position the cuff according to the size of the endotracheal tube. |
| Conventional group | No intervention | –Adjust the position of the endotracheal tube to account for movement in the surgical position and confirm that the endotracheal tube air sac is palpable at the suprasternal notch in the final position for surgery. |
Who may qualify
- Ages
- 6 months to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Pediatric patients ages 6 months to 7 years who are scheduled to have an endotracheal tube inserted for facial or intraoral surgery.
Key exclusion criteria (4 listed)
- When difficult intubation is anticipated
- If the patient has deformities such as facial asymmetry due to congenital causes such as genetic diseases or acquired causes such as accidents.
- If the patient or guardian does not agree to participate in the study.
- Other cases deemed unsuitable by the researcher
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 |
|---|---|---|
| ultrasonographic evaluationScreen the front of neck using ultrasound | Procedure or surgery | Ultrasound group |
Primary outcome
percentage of the patients whose cuff is optimally located.
Time frame: at the end of the surgery
Percentage of patients with endotracheal tube cuff located below the cricoid lower margin and at a depth that allows movement of both lungs, as confirmed by postoperative ultrasound.
4 secondary outcomes
Differences in final endotracheal tube fixation depth in the two groups
Time frame: at the end of induction of anesthesia
Incidence of respiratory events
Time frame: throughout the surgery
proportion of final cuff position
Time frame: at the end of the surgery
incidence of postoperative complication
Time frame: at postanesthetic care unit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Individual participant dataSharing planned: No. Limited availability to those deemed appropriate by the researcher.
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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. This study is not recruiting at the moment.
Eun-Hee Kim, M.D., Ph.D. study chair
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasonographic evaluation in people with Intubation, run by Seoul National University Hospital at 1 site in South Korea.
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 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: status not confirmed, as of the sponsor's last update on 28 Nov 2023. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eun-Hee Kim, M.D., Ph.D. (+82-2-2072-3664, beloveun@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of the patients whose cuff is optimally located. (time frame: at the end of the surgery). 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 28 Nov 2023.