Intubation, IntratrachealNCT03938506
The Assessment of the Pilot Balloon Palpation Method in Different-sized Endotracheal Tubes
An observational study of Intubation, Intratracheal, run by Yonsei University at 1 site in South Korea.
Trial summary
Endotracheal tube is a commonly used for general anesthesia in head and neck surgery. It is necessary to place the endotracheal tube in the trachea of the patient and then inflate the cuff with air. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Intubation, Intratracheal
- What is being tested?
- cuff pressure of the endotracheal tube
- How many people
- 208 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2019to Jun 2020
- Phase
- Observational
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult male patients who require endotracheal intubation using the endotracheal tube size of 6.0 or 8.0
Who may be able to join
- 1. Adult male patients who require endotracheal intubation using the endotracheal tube size of 6.0 or 8.0
Who cannot join
- 1. Patients under 20 years old
- 2. Patients receiving emergency surgery
- 3. Patients with tracheostomy tubes
- 4. Pregnant women
- 5. Patients who can not read the consent form or are not fluent in Korean
- 6. Patients who refused the clinical trial
- 7. Patient with endotracheal mass in the trachea where the cuff is located
- 8. Tracheal deviation is observed in the neck due to tumor in the neck
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, 03722
About this study
Endotracheal tube is a commonly used for general anesthesia in head and neck surgery. It is necessary to place the endotracheal tube in the trachea of the patient and then inflate the cuff with air. This is because the air-inflated cuff contacts the inner wall of the patient's trachea to deliver oxygen through the tube. If the cuff does not inflate, oxygen will leak through the space between the cuff and the patient's trachea. In addition, the risk of pneumonia increases. Therefore, after placing the endotracheal tube in the patient's trachea, the cuff is immediately inflated with air. However, when the cuff is inflated using an excess of air, the cuff may pressurize the mucous membrane of the tracheal wall and cause ischemia. Pressure in the over-inflated cuff was also found to be associated with post-operative sore throat, vocal cord paralysis, and nerve damage. Therefore, appropriate amount of air should be used to inflate the cuff into the air and adjust the pressure within the cuff to be within the range of 20-30 cmH2O. The common method to inflate the endotracheal tube cuff is palpation method. However, the palpation of the cuff is not accurate because of the different size between the pilot balloon and the cuff. Thus, the investigators hypothesized that the different size of the tube will affect the accuracy of the palpation method.
- Conditions
- Intubation, Intratracheal
- Being tested
- cuff pressure of the endotracheal tube
- Keywords
- Adult male patients who require endotracheal intubation using the endotracheal tube size of 6.0 or 8.0, endotracheal tube cuff
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cuff pressure of the endotracheal tubeOther
The endotracheal intubation will be performed after the anesthetic induction. The cuff will be inflated using the air by the palpation method. The cuff pressure of the endotracheal tube will be measured using the manometer.
| Study group | Role | What they receive |
|---|---|---|
| intubation using the endotracheal tube size of 6.0 or 8.0 | Adult male patients who require endotracheal intubation using the endotracheal tube size of 6.0 or 8.0 Receives: Other: cuff pressure of the endotracheal tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence rate when the pressure in the cuff of the endotracheal tube is not within the proper range.
the investigator will monitor the pressure of the endotracheal tube cuff after anesthetic induction.
Measured: participants will followed until the completion of the anesthetic induction (less than 15 minutes).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study startNov 2019 (estimated)
- Primary completionMay 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intubation, IntratrachealStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03938506
- Sponsor's protocol ID
- 4-2019-0104
- Status last verified
- May 2019
- First submitted
- 3 May 2019
- Last updated
- 9 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ban MG, Kim SY, Kim MS, Park WK, Kwon YI, Kim HJ. Accuracy of pilot balloon palpation for cuff pressure assessment in small versus large sized tubes: a prospective non-randomized observational study. Sci Rep. 2023 Apr 5;13(1):5580. doi: 10.1038/s41598-023-32704-3.
PubMed 37020098
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Assessment of the Pilot Balloon Palpation Method in Different-sized Endotracheal Tubes
- ClinicalTrials.gov ID
- NCT03938506
- Acronym / sponsor ID
- 4-2019-0104
- Conditions
- Intubation, Intratracheal
- Keywords
- Adult male patients who require endotracheal intubation using the endotracheal tube size of 6.0 or 8.0, endotracheal tube cuff
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Nov 2019 (estimated)
- Primary completion
- May 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 6 May 2019 (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.
Endotracheal tube is a commonly used for general anesthesia in head and neck surgery. It is necessary to place the endotracheal tube in the trachea of the patient and then inflate the cuff with air. This is because the air-inflated cuff contacts the inner wall of the patient's trachea to deliver oxygen through the tube. If the cuff does not inflate, oxygen will leak through the space between the cuff and the patient's trachea. In addition, the risk of pneumonia increases. Therefore, after placing the endotracheal tube in the patient's trachea, the cuff is immediately inflated with air. However, when the cuff is inflated using an excess of air, the cuff may pressurize the mucous membrane of the tracheal wall and cause ischemia. Pressure in the over-inflated cuff was also found to be associated with post-operative sore throat, vocal cord paralysis, and nerve damage. Therefore, appropriate amount of air should be used to inflate the cuff into the air and adjust the pressure within the cuff to be within the range of 20-30 cmH2O. The common method to inflate the endotracheal tube cuff is palpation method. However, the palpation of the cuff is not accurate because of the different size between the pilot balloon and the cuff. Thus, the investigators hypothesized that the different size of the tube will affect the accuracy of the palpation method.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intubation using the endotracheal tube size of 6.0 or 8.0 | – | Other: cuff pressure of the endotracheal tubeAdult male patients who require endotracheal intubation using the endotracheal tube size of 6.0 or 8.0 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult male patients who require endotracheal intubation using the endotracheal tube size of 6.0 or 8.0
Key inclusion criteria (1 listed)
- 1. Adult male patients who require endotracheal intubation using the endotracheal tube size of 6.0 or 8.0
Key exclusion criteria (8 listed)
- 1. Patients under 20 years old
- 2. Patients receiving emergency surgery
- 3. Patients with tracheostomy tubes
- 4. Pregnant women
- 5. Patients who can not read the consent form or are not fluent in Korean
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 of the endotracheal tubeThe endotracheal intubation will be performed after the anesthetic induction. The cuff will be inflated using the air by the palpation method. The cuff pressure of the endotracheal tube will be measured using the manometer. | Other | intubation using the endotracheal tube size of 6.0 or 8.0 |
Primary outcome
The incidence rate when the pressure in the cuff of the endotracheal tube is not within the proper range.
Time frame: participants will followed until the completion of the anesthetic induction (less than 15 minutes).
the investigator will monitor the pressure of the endotracheal tube cuff after anesthetic induction.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2019.
- Derived from this study: PubMed 37020098Ban MG, Kim SY, Kim MS, Park WK, Kwon YI, Kim HJ. Accuracy of pilot balloon palpation for cuff pressure assessment in small versus large sized tubes: a prospective non-randomized observational study. Sci Rep. 2023 Apr 5;13(1):5580. doi: 10.1038/s41598-023-32704-3.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Intubation, Intratracheal, run by Yonsei University 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 8 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 9 May 2019. 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?
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?
The incidence rate when the pressure in the cuff of the endotracheal tube is not within the proper range. (time frame: participants will followed until the completion of the anesthetic induction (less than 15 minutes).). 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 NCT03938506, which also lists 1 linked publication.
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 9 May 2019.