Anesthesia, GeneralNCT06107998
Comparison of Different Methods for Determining Endotracheal Cuff Pressure
A study testing stethoscope and Audible leak/Balloon palpation in people with Anesthesia, General and Intubation, Intratracheal, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to test whether the stethoscope can be used as a method of assessing endotracheal cuff pressure as effectively as a manometer and also to compare it with the balloon palpation/audible leak method frequently used in clinical practice in adult patients undergoing general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anesthesia, General, Intubation, Intratracheal
- What is being tested?
- stethoscope and Audible leak/Balloon palpation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Nov 2023to 2 Jan 2024
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being between the ages of 18-65
- Planning the operation under general anesthesia
- Performing endotracheal intubation during general anesthesia
- Elective surgeries
- Volunteering to participate in the study
Who cannot join
- Having a history of difficult intubation before
- Difficulty during intubation (repeated intubation attempts, etc.)
- rapid sequence intubation requirement
- Planning to undergo head and neck surgery
- Those with tracheal stenosis
- Previous intervention to the neck area (radiotherapy, tracheotomy, etc.)
Show all 12Show fewer
- Pregnancy
- Obesity
- Those with respiratory diseases (COPD, asthma, etc.)
- Emergency surgery
- American Society of Anaesthesiologists physical status>3
- Refusing to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Suleyman Demirel University
Isparta, Merkez, 32200
About this study
Official title: Comparison of the Audible Leak-balloon Palpation Method and the Stethoscope-guided Method for Endotracheal Tube Cuff Inflation
The goal of this clinical trial is to test whether the stethoscope can be used as a method of assessing endotracheal cuff pressure as effectively as a manometer and also to compare it with the balloon palpation/audible leak method frequently used in clinical practice in adult patients undergoing general anesthesia.
The main questions it aims to answer are:
Read more
- Is the stethoscope as effective as a manometer in assessing endotracheal cuff pressure?
- Is there a difference between stethoscope and audible leak/balloon palpation methods in assessing endotracheal cuff pressure? Participants will be randomly divided into 2 groups.
- Group P: After intubation, endotracheal cuff pressure will be assessed by audible leak/balloon palpation.
- Group S: After intubation, endotracheal cuff pressure will be assessed with a stethoscope.
- Control will be carried out with a manometer and the pressure values obtained in the groups will be corrected.
Researchers will compare ''stethoscope'' and ''audible leak/balloon palpation'' groups to see if which method is effective like a manometer.
Read the detailed description
Although the use of a manometer is recommended in daily practice to evaluate endotracheal tube cuff pressure for intubated patients, the cuff is still inflated using balloon palpation or audible leakage methods in many centers. Manometers may not be available in most centers. An acceptable cuff pressure ranges from 20 to 30 cm H2O. While the risk of aspiration increases below 20 cm H2O, at values above 30 cm H2O the circulation of the tracheal mucosa begins to deteriorate and related complications like ulceration, stenosis, and even fistula may develop.
The authors hypothesize that the stethoscope is as effective as a manometer in assessing endotracheal tube cuff pressure where a manometer is not available.
After informed consent is obtained from patients who meet the inclusion criteria for the study, the patients will be intubated following anesthesia induction and the method by which the patients' endotracheal tube cuffs will be inflated will be determined in a randomized manner using the sealed envelope method. Then, the cuff pressures will be checked with a manometer by an expert who does not know the method by which the cuff is inflated, if necessary, it will be corrected and the data will be recorded with the code assigned to the method. Statistical evaluations will be made on the data obtained by an analyst who does not know the names of the methods and which method was applied to which patient.
The difference between our study and previous studies:
- Previous studies had small numbers of patients.
- The authors designed a randomized controlled study with triple masking.
- Conditions
- Anesthesia, General, Intubation, Intratracheal
- Being tested
- stethoscope, Audible leak/Balloon palpation
- Keywords
- Cuff pressure, Endotracheal intubation, endotracheal tube, inflation, measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stethoscopeOther
endotracheal tube cuff will be inflated via stethoscope guidance
Audible leak/Balloon palpationOther
endotracheal tube cuff will be inflated via audible leak/balloon palpation method
| Study group | Role | What they receive |
|---|---|---|
| Stethoscope | Experimental | Patients whose endotracheal tube cuff is inflated via a stethoscope Receives: Other: stethoscope |
| Audible leak/Balloon palpation | Active comparator | Patients whose endotracheal tube cuff is inflated via audible leak/balloon palpation method. Receives: Other: Audible leak/Balloon palpation |
What is being measured
The primary outcome is the main question the study is designed to answer.
cuff pressure of air introduced
After the cuffs inflated using the specified methods are checked with a manometer, it will be noted whether there is any difference between the required pressures (centimeter of water/cm H2O).
Measured: After the patients are intubated and tube cuff inflated
cuff volume of air introduced
After the cuffs inflated using the specified methods are checked with a manometer, it will be noted whether there is any difference between the required additional volumes (milliliters/mL).
Measured: After the patients are intubated and tube cuff inflated
Secondary outcomes (2)
endotracheal tube diameters
The authors will also investigate whether cuff pressure adjustments vary by endotracheal tube diameter (Millimeter/mm)
Measured: After induction of anesthesia and intubation
endotracheal tube brands
The authors will also investigate whether cuff pressure adjustments vary by endotracheal tube brands. The brands will be noted as A, B, C, D..etc.
Measured: After induction of anesthesia and intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start2 Nov 2023
- Primary completion29 Dec 2023
- Study completion2 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, GeneralStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Soner Ozcan, Suleyman Demirel University
- Investigators
- Mustafa Soner Özcan, M.D., Principal investigator, Suleyman Demirel University,Faculty of Medicine, Department of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06107998
- Sponsor's protocol ID
- SNR-10/143
- Status last verified
- Jan 2024
- First submitted
- 21 Oct 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After the study is finished, data from the study will be shared when reasonable reasons are presented.
Publications
Kumar CM, Seet E, Van Zundert TCRV. Measuring endotracheal tube intracuff pressure: no room for complacency. J Clin Monit Comput. 2021 Feb;35(1):3-10. doi: 10.1007/s10877-020-00501-2. Epub 2020 Mar 20.
PubMed 32198671Duarte NMDC, Caetano AMM, Arouca GO, Ferrreira AT, Figueiredo JL. [Subjective method for tracheal tube cuff inflation: performance of anesthesiology residents and staff anesthesiologists. Prospective observational study]. Braz J Anesthesiol. 2020 Jan-Feb;70(1):9-14. doi: 10.1016/j.bjan.2019.09.010. Epub 2020 Feb 19.
PubMed 32199655Borhazowal R, Harde M, Bhadade R, Dave S, Aswar SG. Comparison between Two Endotracheal Tube Cuff Inflation Methods; Just-Seal Vs. Stethoscope-Guided. J Clin Diagn Res. 2017 Jun;11(6):UC01-UC03. doi: 10.7860/JCDR/2017/26301.10017. Epub 2017 Jun 1.
PubMed 28764268Satya Prakash MVS, Aravind C, Mohan VK. Comparative evaluation of three methods of endotracheal tube cuff inflation for adequacy of seal. J Anaesthesiol Clin Pharmacol. 2022 Oct-Dec;38(4):588-593. doi: 10.4103/joacp.JOACP_560_20. Epub 2022 Jun 15.
PubMed 36778817Unsal O, Seyhun N, Turk B, Ekici M, Dobrucali H, Turgut S. The Evaluation of Upper Airway Complications Secondary to Intubation: Cuff Pressure Manometer Versus Conventional Palpation Method. Sisli Etfal Hastan Tip Bul. 2018 Dec 28;52(4):289-295. doi: 10.5350/SEMB.20171214085933. eCollection 2018.
PubMed 32774093
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Audible Leak-balloon Palpation Method and the Stethoscope-guided Method for Endotracheal Tube Cuff Inflation
- ClinicalTrials.gov ID
- NCT06107998
- Acronym / sponsor ID
- SNR-10/143
- Conditions
- Anesthesia, General, Intubation, Intratracheal
- Keywords
- Cuff pressure, Endotracheal intubation, endotracheal tube, inflation, measurement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 2 Nov 2023 (actual)
- Primary completion
- 29 Dec 2023 (actual)
- Study completion
- 2 Jan 2024 (actual)
- First posted
- 30 Oct 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 goal of this clinical trial is to test whether the stethoscope can be used as a method of assessing endotracheal cuff pressure as effectively as a manometer and also to compare it with the balloon palpation/audible leak method frequently used in clinical practice in adult patients undergoing general anesthesia.
The main questions it aims to answer are:
- Is the stethoscope as effective as a manometer in assessing endotracheal cuff pressure?
- Is there a difference between stethoscope and audible leak/balloon palpation methods in assessing endotracheal cuff pressure? Participants will be randomly divided into 2 groups.
- Group P: After intubation, endotracheal cuff pressure will be assessed by audible leak/balloon palpation.
- Group S: After intubation, endotracheal cuff pressure will be assessed with a stethoscope.
- Control will be carried out with a manometer and the pressure values obtained in the groups will be corrected.
Researchers will compare ''stethoscope'' and ''audible leak/balloon palpation'' groups to see if which method is effective like a manometer.
Detailed description
Although the use of a manometer is recommended in daily practice to evaluate endotracheal tube cuff pressure for intubated patients, the cuff is still inflated using balloon palpation or audible leakage methods in many centers. Manometers may not be available in most centers. An acceptable cuff pressure ranges from 20 to 30 cm H2O. While the risk of aspiration increases below 20 cm H2O, at values above 30 cm H2O the circulation of the tracheal mucosa begins to deteriorate and related complications like ulceration, stenosis, and even fistula may develop.
The authors hypothesize that the stethoscope is as effective as a manometer in assessing endotracheal tube cuff pressure where a manometer is not available.
After informed consent is obtained from patients who meet the inclusion criteria for the study, the patients will be intubated following anesthesia induction and the method by which the patients' endotracheal tube cuffs will be inflated will be determined in a randomized manner using the sealed envelope method. Then, the cuff pressures will be checked with a manometer by an expert who does not know the method by which the cuff is inflated, if necessary, it will be corrected and the data will be recorded with the code assigned to the method. Statistical evaluations will be made on the data obtained by an analyst who does not know the names of the methods and which method was applied to which patient.
The difference between our study and previous studies:
- Previous studies had small numbers of patients.
- The authors designed a randomized controlled study with triple masking.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stethoscope | Experimental | Other: stethoscopePatients whose endotracheal tube cuff is inflated via a stethoscope |
| Audible leak/Balloon palpation | Active comparator | Other: Audible leak/Balloon palpationPatients whose endotracheal tube cuff is inflated via audible leak/balloon palpation method. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being between the ages of 18-65
- Planning the operation under general anesthesia
- Performing endotracheal intubation during general anesthesia
- Elective surgeries
- Volunteering to participate in the study
Key exclusion criteria (12 listed)
- Having a history of difficult intubation before
- Difficulty during intubation (repeated intubation attempts, etc.)
- rapid sequence intubation requirement
- Planning to undergo head and neck surgery
- Those with tracheal stenosis
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 |
|---|---|---|
| stethoscopeendotracheal tube cuff will be inflated via stethoscope guidance | Other | Stethoscope |
| Audible leak/Balloon palpationendotracheal tube cuff will be inflated via audible leak/balloon palpation method | Other | Audible leak/Balloon palpation |
Primary outcome
cuff pressure of air introduced
Time frame: After the patients are intubated and tube cuff inflated
After the cuffs inflated using the specified methods are checked with a manometer, it will be noted whether there is any difference between the required pressures (centimeter of water/cm H2O).
cuff volume of air introduced
Time frame: After the patients are intubated and tube cuff inflated
After the cuffs inflated using the specified methods are checked with a manometer, it will be noted whether there is any difference between the required additional volumes (milliliters/mL).
2 secondary outcomes
endotracheal tube diameters
Time frame: After induction of anesthesia and intubation
endotracheal tube brands
Time frame: After induction of anesthesia and intubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Background: PubMed 32198671Kumar CM, Seet E, Van Zundert TCRV. Measuring endotracheal tube intracuff pressure: no room for complacency. J Clin Monit Comput. 2021 Feb;35(1):3-10. doi: 10.1007/s10877-020-00501-2. Epub 2020 Mar 20.
- Background: PubMed 32199655Duarte NMDC, Caetano AMM, Arouca GO, Ferrreira AT, Figueiredo JL. [Subjective method for tracheal tube cuff inflation: performance of anesthesiology residents and staff anesthesiologists. Prospective observational study]. Braz J Anesthesiol. 2020 Jan-Feb;70(1):9-14. doi: 10.1016/j.bjan.2019.09.010. Epub 2020 Feb 19.
- Results publication: PubMed 28764268Borhazowal R, Harde M, Bhadade R, Dave S, Aswar SG. Comparison between Two Endotracheal Tube Cuff Inflation Methods; Just-Seal Vs. Stethoscope-Guided. J Clin Diagn Res. 2017 Jun;11(6):UC01-UC03. doi: 10.7860/JCDR/2017/26301.10017. Epub 2017 Jun 1.
- Results publication: PubMed 36778817Satya Prakash MVS, Aravind C, Mohan VK. Comparative evaluation of three methods of endotracheal tube cuff inflation for adequacy of seal. J Anaesthesiol Clin Pharmacol. 2022 Oct-Dec;38(4):588-593. doi: 10.4103/joacp.JOACP_560_20. Epub 2022 Jun 15.
- Results publication: PubMed 32774093Unsal O, Seyhun N, Turk B, Ekici M, Dobrucali H, Turgut S. The Evaluation of Upper Airway Complications Secondary to Intubation: Cuff Pressure Manometer Versus Conventional Palpation Method. Sisli Etfal Hastan Tip Bul. 2018 Dec 28;52(4):289-295. doi: 10.5350/SEMB.20171214085933. eCollection 2018.
- Individual participant dataSharing planned: No. After the study is finished, data from the study will be shared when reasonable reasons are presented.
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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.
Mustafa Soner Özcan, M.D. principal investigator
Suleyman Demirel University,Faculty of Medicine, Department of Anesthesiology and Reanimation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stethoscope and Audible leak/Balloon palpation in people with Anesthesia, General and Intubation, Intratracheal, run by Suleyman Demirel University 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 5 inclusion and 12 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: finished, as of the sponsor's last update on 5 Jan 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
cuff pressure of air introduced (time frame: After the patients are intubated and tube cuff inflated). The study lists 2 primary outcomes in all. 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 NCT06107998, which also lists 5 linked publications.
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 5 Jan 2024.