Endotracheal Tube Cuff PressureNCT07844486
Effect of Loss-of-Resistance Syringe Training on Endotracheal Tube Cuff Pressure
An observational study of Endotracheal Tube Cuff Pressure and Postoperative Sore Throat, run by Yusuf YILMAZ at 1 site in Turkey (Türkiye).
Trial summary
This study will examine whether training the anesthesia team in a loss-of-resistance syringe technique is associated with improved breathing-tube cuff pressure in adults having surgery at Kayseri City Hospital. The cuff is an inflatable seal around the breathing tube. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endotracheal Tube Cuff Pressure, Postoperative Sore Throat
- Type of treatment
- Injection or infusion
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2026to 30 Nov 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive adult surgical patients undergoing general anesthesia with endotracheal intubation at Kayseri City Hospital during the two-week observation period before anesthesia staff training and the two-week observation period after training. Participants must meet the inclusion and exclusion criteria. Only the first surgical procedure for each patient will be included.
Who may be able to join
- Age 18 years or older.
- Undergoing general anesthesia with endotracheal intubation in the operating rooms of Kayseri City Hospital.
- Able to communicate and undergo postoperative pain assessment.
- Only the first surgical procedure for each patient is included.
Who cannot join
- Neurological, psychiatric or cognitive impairment preventing communication.
- Surgery that may independently affect postoperative sore throat, such as ear, nose and throat surgery or upper gastrointestinal surgery.
- Three or more laryngoscopy attempts during intubation.
- Nasotracheal intubation.
- Use of a double-lumen endotracheal tube.
- Intubation lasting longer than three hours.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Training in the Loss-of-Resistance Syringe Technique on Optimizing Endotracheal Tube Cuff Pressure: A Prospective Before-and-After Study
This study will examine whether training the anesthesia team in a loss-of-resistance syringe technique is associated with improved breathing-tube cuff pressure in adults having surgery at Kayseri City Hospital. The cuff is an inflatable seal around the breathing tube. Pressure that is too high or too low may cause problems.
Approximately 180 adults will be observed during a two-week period before staff training and a two-week period after training. The treating clinical team will independently choose how to inflate each cuff as part of routine care; researchers will not assign patients to a technique. A researcher independent of the treating team will measure cuff pressure and will learn which technique was used only after the measurement.
The main outcome is the percentage of patients whose first measured cuff pressure is within 20-30 cmH2O, compared between the periods before and after training. Pressures outside this range will be corrected for patient safety after the first measurement is recorded. Researchers will also record cuff leakage, the need for additional air, and sore throat after the breathing tube is removed, once the patient is awake and able to answer questions.
Read the detailed description
This is a prospective, single-center observational before-and-after study in the operating rooms of Kayseri City Hospital. Consecutive eligible adult patients undergoing general anesthesia with endotracheal intubation will be observed in two temporal cohorts: a two-week pre-training cohort and a two-week post-training cohort. Only the first surgical procedure for each patient will be included.
Between the observation periods, anesthesia physicians and anesthesia technicians will receive standardized theoretical and practical education on cuff pressure management and the loss-of-resistance syringe technique. The education covers the target pressure range, the consequences of excessive or insufficient pressure, the syringe's low-friction plunger mechanism, and practical application. With this technique, the cuff is inflated through the pilot balloon valve using a loss-of-resistance syringe. Force on the plunger is then released, allowing it to move backward passively as air returns from the cuff. The syringe is disconnected when spontaneous plunger movement stops.
The clinical team independently decides whether and how to use a cuff inflation technique in routine clinical care. The research protocol does not assign patients to a technique. Researchers independent of the clinical team measure cuff pressure with a manometer after initial cuff inflation and before any corrective adjustment. The researcher measuring cuff pressure is unaware of the inflation technique until after the pressure has been measured and recorded. The initial value, rather than the value after safety correction, is used for the primary outcome. Pressures outside 20-30 cmH2O are corrected promptly for patient safety.
Cuff leakage and the need for additional air are recorded. Postoperative sore throat is assessed after extubation during postoperative recovery, once the patient is awake and able to answer questions. Demographic characteristics, surgical procedure, intubation attempts, tube characteristics and procedure durations are also recorded.
The primary analysis compares the proportion of patients with initial cuff pressure within 20-30 cmH2O between the pre-training and post-training cohorts, using the chi-square test or Fisher's exact test when appropriate. Cohorts are defined by observation period, not by the cuff inflation technique actually used. Continuous cuff pressure values will be compared using an independent-samples t test or the Mann-Whitney U test according to distribution. Secondary categorical outcomes will be compared using the chi-square test or Fisher's exact test. If appropriate, multivariable logistic regression will explore factors associated with postoperative sore throat. All tests will be two-sided with a significance level of 0.05.
Estimated enrollment is 180 patients, with approximately equal numbers in each observation period. The protocol sample-size calculation is based on detecting a 25-percentage-point absolute difference in the primary proportion with 90% power and a two-sided alpha of 0.05. Final participant assessment is anticipated on November 30, 2026; analysis and reporting will take place afterward.
- Keywords
- Loss-of-resistance syringe, Anesthesia education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pre-Training Cohort | Consecutive eligible adults undergoing general anesthesia with endotracheal intubation during the two-week period before staff training. Cuff inflation is selected and performed independently by the treating clinical team as part of routine care. An independent researcher records initial cuff pressure before corrective adjustment and learns the inflation technique only afterward. Cuff leakage, additional air requirement and postoperative sore throat are assessed. | |
| Post-Training Cohort | Consecutive eligible adults undergoing general anesthesia with endotracheal intubation during the two-week period after staff training in the loss-of-resistance syringe technique. The treating clinical team independently chooses and performs the cuff inflation technique in routine care; no technique is assigned by researchers. An independent researcher records initial cuff pressure before corrective adjustment and learns the technique only afterward. Cuff leakage, additional air requirement and postoperative sore throat are assessed using the same procedures as in the pre-training cohort. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients With Initial Endotracheal Tube Cuff Pressure Within 20-30 cmH2O
Percentage of patients whose initial endotracheal tube cuff pressure, measured with a cuff manometer after intubation and initial cuff inflation and before any corrective adjustment, is between 20 and 30 cmH2O inclusive. The proportion will be compared between the pre-training and post-training cohorts. Measurements are performed by researchers independent of the clinical team, who learn the cuff inflation technique only after recording cuff pressure. This binary outcome is the basis of the sample-size calculation.
Measured: Immediately after endotracheal intubation and initial cuff inflation, before corrective pressure adjustment, during the index surgical procedure.
Secondary outcomes (4)
Initial Endotracheal Tube Cuff Pressure
Initial cuff pressure measured with a cuff manometer in cmH2O before corrective adjustment, analyzed as a continuous variable and compared between the pre-training and post-training cohorts. The researcher learns the cuff inflation technique only after recording the measurement.
Measured: Immediately after endotracheal intubation and initial cuff inflation, before corrective pressure adjustment, during the index surgical procedure.
Proportion of Patients With Endotracheal Tube Cuff Leakage
Percentage of patients with cuff leakage, recorded as present or absent based on information from the treating anesthesia team during initial cuff inflation and assessment. The proportion will be compared between the pre-training and post-training cohorts.
Measured: During initial cuff inflation and assessment after endotracheal intubation in the index surgical procedure.
Proportion of Patients Requiring Additional Air for Cuff Inflation
Percentage of patients requiring additional air after initial cuff inflation, recorded as yes or no based on information from the treating anesthesia team. The proportion will be compared between the pre-training and post-training cohorts.
Measured: Periprocedural
Proportion of Patients With Postoperative Sore Throat
Percentage of patients reporting sore throat when questioned after extubation during postoperative recovery, once awake and able to answer questions. Sore throat is recorded as present or absent and compared between the pre-training and post-training cohorts.
Measured: At the first postoperative assessment after extubation when the patient is awake and able to answer questions, during recovery from the index surgical procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (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 Endotracheal Tube Cuff PressureStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yusuf YILMAZ
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Yusuf YILMAZ, Kayseri City Hospital
- Investigators
- Yusuf Yilmaz, MD, Principal investigator, Kayseri City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07844486
- Sponsor's protocol ID
- KCH-LOR-2026
- Other IDs
- 1078
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bulamba F, Kintu A, Ayupo N, Kojjo C, Ssemogerere L, Wabule A, Kwizera A. Achieving the Recommended Endotracheal Tube Cuff Pressure: A Randomized Control Study Comparing Loss of Resistance Syringe to Pilot Balloon Palpation. Anesthesiol Res Pract. 2017;2017:2032748. doi: 10.1155/2017/2032748. Epub 2017 Dec 31.
PubMed 29463980
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Training in the Loss-of-Resistance Syringe Technique on Optimizing Endotracheal Tube Cuff Pressure: A Prospective Before-and-After Study
- ClinicalTrials.gov ID
- NCT07844486
- Acronym / sponsor ID
- KCH-LOR-2026
- Keywords
- Loss-of-resistance syringe, Anesthesia education
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Yusuf YILMAZOther government
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 28 Sep 2026 (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.
This study will examine whether training the anesthesia team in a loss-of-resistance syringe technique is associated with improved breathing-tube cuff pressure in adults having surgery at Kayseri City Hospital. The cuff is an inflatable seal around the breathing tube. Pressure that is too high or too low may cause problems.
Approximately 180 adults will be observed during a two-week period before staff training and a two-week period after training. The treating clinical team will independently choose how to inflate each cuff as part of routine care; researchers will not assign patients to a technique. A researcher independent of the treating team will measure cuff pressure and will learn which technique was used only after the measurement.
The main outcome is the percentage of patients whose first measured cuff pressure is within 20-30 cmH2O, compared between the periods before and after training. Pressures outside this range will be corrected for patient safety after the first measurement is recorded. Researchers will also record cuff leakage, the need for additional air, and sore throat after the breathing tube is removed, once the patient is awake and able to answer questions.
Detailed description
This is a prospective, single-center observational before-and-after study in the operating rooms of Kayseri City Hospital. Consecutive eligible adult patients undergoing general anesthesia with endotracheal intubation will be observed in two temporal cohorts: a two-week pre-training cohort and a two-week post-training cohort. Only the first surgical procedure for each patient will be included.
Between the observation periods, anesthesia physicians and anesthesia technicians will receive standardized theoretical and practical education on cuff pressure management and the loss-of-resistance syringe technique. The education covers the target pressure range, the consequences of excessive or insufficient pressure, the syringe's low-friction plunger mechanism, and practical application. With this technique, the cuff is inflated through the pilot balloon valve using a loss-of-resistance syringe. Force on the plunger is then released, allowing it to move backward passively as air returns from the cuff. The syringe is disconnected when spontaneous plunger movement stops.
The clinical team independently decides whether and how to use a cuff inflation technique in routine clinical care. The research protocol does not assign patients to a technique. Researchers independent of the clinical team measure cuff pressure with a manometer after initial cuff inflation and before any corrective adjustment. The researcher measuring cuff pressure is unaware of the inflation technique until after the pressure has been measured and recorded. The initial value, rather than the value after safety correction, is used for the primary outcome. Pressures outside 20-30 cmH2O are corrected promptly for patient safety.
Cuff leakage and the need for additional air are recorded. Postoperative sore throat is assessed after extubation during postoperative recovery, once the patient is awake and able to answer questions. Demographic characteristics, surgical procedure, intubation attempts, tube characteristics and procedure durations are also recorded.
The primary analysis compares the proportion of patients with initial cuff pressure within 20-30 cmH2O between the pre-training and post-training cohorts, using the chi-square test or Fisher's exact test when appropriate. Cohorts are defined by observation period, not by the cuff inflation technique actually used. Continuous cuff pressure values will be compared using an independent-samples t test or the Mann-Whitney U test according to distribution. Secondary categorical outcomes will be compared using the chi-square test or Fisher's exact test. If appropriate, multivariable logistic regression will explore factors associated with postoperative sore throat. All tests will be two-sided with a significance level of 0.05.
Estimated enrollment is 180 patients, with approximately equal numbers in each observation period. The protocol sample-size calculation is based on detecting a 25-percentage-point absolute difference in the primary proportion with 90% power and a two-sided alpha of 0.05. Final participant assessment is anticipated on November 30, 2026; analysis and reporting will take place afterward.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-Training Cohort | – | –Consecutive eligible adults undergoing general anesthesia with endotracheal intubation during the two-week period before staff training. Cuff inflation is selected and performed independently by the treating clinical team as part of routine care. An independent researcher records initial cuff pressure before corrective adjustment and learns the inflation technique only afterward. Cuff leakage, additional air requirement and postoperative sore throat are assessed. |
| Post-Training Cohort | – | –Consecutive eligible adults undergoing general anesthesia with endotracheal intubation during the two-week period after staff training in the loss-of-resistance syringe technique. The treating clinical team independently chooses and performs the cuff inflation technique in routine care; no technique is assigned by researchers. An independent researcher records initial cuff pressure before corrective adjustment and learns the technique only afterward. Cuff leakage, additional air requirement and postoperative sore throat are assessed using the same procedures as in the pre-training cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive adult surgical patients undergoing general anesthesia with endotracheal intubation at Kayseri City Hospital during the two-week observation period before anesthesia staff training and the two-week observation period after training. Participants must meet the inclusion and exclusion criteria. Only the first surgical procedure for each patient will be included.
Key inclusion criteria (4 listed)
- Age 18 years or older.
- Undergoing general anesthesia with endotracheal intubation in the operating rooms of Kayseri City Hospital.
- Able to communicate and undergo postoperative pain assessment.
- Only the first surgical procedure for each patient is included.
Key exclusion criteria (6 listed)
- Neurological, psychiatric or cognitive impairment preventing communication.
- Surgery that may independently affect postoperative sore throat, such as ear, nose and throat surgery or upper gastrointestinal surgery.
- Three or more laryngoscopy attempts during intubation.
- Nasotracheal intubation.
- Use of a double-lumen endotracheal tube.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of Patients With Initial Endotracheal Tube Cuff Pressure Within 20-30 cmH2O
Time frame: Immediately after endotracheal intubation and initial cuff inflation, before corrective pressure adjustment, during the index surgical procedure.
Percentage of patients whose initial endotracheal tube cuff pressure, measured with a cuff manometer after intubation and initial cuff inflation and before any corrective adjustment, is between 20 and 30 cmH2O inclusive. The proportion will be compared between the pre-training and post-training cohorts. Measurements are performed by researchers independent of the clinical team, who learn the cuff inflation technique only after recording cuff pressure. This binary outcome is the basis of the sample-size calculation.
4 secondary outcomes
Initial Endotracheal Tube Cuff Pressure
Time frame: Immediately after endotracheal intubation and initial cuff inflation, before corrective pressure adjustment, during the index surgical procedure.
Proportion of Patients With Endotracheal Tube Cuff Leakage
Time frame: During initial cuff inflation and assessment after endotracheal intubation in the index surgical procedure.
Proportion of Patients Requiring Additional Air for Cuff Inflation
Time frame: Periprocedural
Proportion of Patients With Postoperative Sore Throat
Time frame: At the first postoperative assessment after extubation when the patient is awake and able to answer questions, during recovery from the index surgical procedure.
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 28 Sep 2026.
- Background: PubMed 29463980Bulamba F, Kintu A, Ayupo N, Kojjo C, Ssemogerere L, Wabule A, Kwizera A. Achieving the Recommended Endotracheal Tube Cuff Pressure: A Randomized Control Study Comparing Loss of Resistance Syringe to Pilot Balloon Palpation. Anesthesiol Res Pract. 2017;2017:2032748. doi: 10.1155/2017/2032748. Epub 2017 Dec 31.
- 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.
Yusuf Yilmaz, MD principal investigator
Kayseri City 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 Tube Cuff Pressure and Postoperative Sore Throat, run by Yusuf YILMAZ 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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 28 Sep 2026. 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 Yusuf Yilmaz, MD (+90 555 538 30 94, doktoryusufyilmaz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients With Initial Endotracheal Tube Cuff Pressure Within 20-30 cmH2O (time frame: Immediately after endotracheal intubation and initial cuff inflation, before corrective pressure adjustment, during the index surgical procedure.). 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 NCT07844486, 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 28 Sep 2026.