IntubationNCT07891195
Effect of a Brief Educational Intervention on Endotracheal Tube Cuff Pressure
A study testing Brief educational intervention (educational video and reminder posters) in people with Intubation and Endotracheal Tube Cuff Pressure, run by Marmara University Pendik Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Endotracheal tube cuff pressure outside the recommended range of 20-30 cmH₂O is common in routine anesthesia practice. Over-inflation can injure the tracheal mucosa, while under-inflation increases the risk of aspiration and ventilator-associated pneumonia. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Intubation, Endotracheal Tube Cuff Pressure, Anesthesia
- What is being tested?
- Brief educational intervention (educational video and reminder posters)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Oct 2026to Nov 2026
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Adult patients aged 18 years or older
- Elective or emergency surgery under general anaesthesia
- Orotracheal intubation with a cuffed endotracheal tube
- Written informed consent
Who cannot join
- Laparoscopic surgery (pneumoperitoneum alters cuff pressure)
- Use of nitrous oxide during anaesthesia (diffusion into the cuff alters cuff pressure)
- Nasotracheal intubation or use of a supraglottic airway device
- Patients already intubated on arrival to the operating room
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
Marmara University Pendik research and training hospital
Istanbul
Merve Ergenc, +90 (532) 630 96 67, hekimoglumerve@gmail.com
Betul Yusra Sirin, +905308237940, yusrasirin@gmail.com
About this study
Official title: Effect of a Brief Educational Intervention on Endotracheal Tube Cuff Pressure in the Operating Room: A Prospective Pre-Post Study
Endotracheal tube cuff pressure outside the recommended range of 20-30 cmH₂O is common in routine anesthesia practice. Over-inflation can injure the tracheal mucosa, while under-inflation increases the risk of aspiration and ventilator-associated pneumonia. This prospective, single-center, uncontrolled before-and-after study evaluates whether a brief educational intervention improves cuff pressure management in the operating room. Adult patients undergoing general anesthesia with endotracheal intubation at Marmara University Pendik Training and Research Hospital are enrolled in two consecutive periods. In both periods, cuff pressure is measured with a calibrated manometer shortly after intubation, together with the professional role and clinical experience of the provider who inflated the cuff. Between the two periods, a two-minute educational video explaining the importance of optimal cuff pressure and demonstrating manometer use is distributed to all operating room staff involved in cuff inflation, and reminder posters are placed in every operating room. The primary outcome is the proportion of cuff pressure measurements within the recommended range before versus after the intervention. The secondary outcome is the association between the cuff-inflating provider's role and experience and cuff pressure appropriateness. No change to patient care beyond the educational intervention is made.
Read the detailed description
This is a prospective, single-center, pre-post interventional study evaluating whether a brief educational intervention improves endotracheal tube cuff pressure management in routine anesthesia practice. Data are collected over four consecutive weeks: a two-week pre-intervention period, followed by the educational intervention and a two-week post-intervention period.
During both periods, cuff inflation is performed according to the routine practice of the healthcare provider; no inflation technique or measurement method is prescribed, and cuff pressure manometers (VBM Medizintechnik, Germany) are available in all operating rooms, but their use is not mandatory. After intubation and tube fixation, cuff pressure is measured by an investigator with a manometer connected to the pilot balloon, without informing the provider who inflated the cuff, in order to reflect usual practice. Values outside 20-30 cmH₂O are recorded and then adjusted to the recommended range. The professional role (anesthesia technician, resident, or specialist physician) and years of clinical experience of the provider, together with patient demographics, type of surgery, and tube size, are recorded.
The intervention consists of a two-minute educational video explaining the importance of maintaining cuff pressure within the recommended range and demonstrating the use of a cuff manometer, distributed to all operating room staff involved in cuff inflation, and a reminder poster displayed in all operating rooms during the post-intervention period.
The proportion of appropriate cuff pressures is compared between periods using the chi-squared test; the association of provider role and experience with appropriate cuff pressure is examined with logistic regression adjusted for study period. Analyses were performed in Phyton 3.13 using pandas 3.0, SciPy 1.18, and statsmodels 0.15. Based on an institutional pilot study of 10 patients, in which 24% of cuff pressure measurements were within the recommended range, 94 patients per period were required to detect an increase to 49% with a two-sided α of 0.05 and 95% power (two-proportion z-test, G*Power 3.1.9.7). Allowing for 10% missing data and for planned subgroup analyses by provider role and experience, 120 patients per period (240 in total) will be enrolled.
- Being tested
- Brief educational intervention (educational video and reminder posters)
- Keywords
- cuff pressure, endotracheal tube, cuff manometer, education, educational intervention, before-after study, patient safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief educational intervention (educational video and reminder posters)Behavioural
A two-minute educational video explaining the importance of maintaining endotracheal tube cuff pressure within 20-30 cmH₂O, summarising complications of over- and under-inflation, and demonstrating the use of a cuff manometer, distributed via an institutional messaging group to all operating room staff involved in cuff inflation (anaesthesia technicians, resident and specialist physicians). Reminder posters emphasising optimal cuff pressure were displayed in all operating rooms during the post-intervention period. The intervention was directed at healthcare providers, not at patients.
| Study group | Role | What they receive |
|---|---|---|
| pre-intervention period | No intervention | Patients intubated during the two-week period before the educational intervention; cuff pressure measured according to routine practice. |
| post-interventional period | Experimental | Patients intubated during the two-week period after operating room staff received the educational intervention. Receives: Behavioral: Brief educational intervention (educational video and reminder posters) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with endotracheal tube cuff pressure within the recommended range (20-30 cmH₂O)
Endotracheal tube cuff pressure measured once by an investigator with a calibrated aneroid cuff manometer (VBM Medizintechnik, Germany) after tube fixation, with the patient supine and before surgical positioning, without informing the provider who inflated the cuff. A pressure of 20-30 cmH₂O is classified as appropriate. The proportion of patients with an appropriate cuff pressure is compared between the pre- and post-intervention periods and expressed as a risk ratio, odds ratio, and absolute difference in proportions with 95% confidence intervals.
Measured: Within 10 minutes after endotracheal tube fixation, before the surgery starts, on the day of surgery (single measurement per patient)
Secondary outcomes (1)
Association between the cuff-inflating provider's professional role and clinical experience and cuff pressure appropriateness
Proportion of patients with an appropriate cuff pressure (20-30 cmH₂O) according to the professional role of the provider who inflated the cuff (anesthesia technician, resident physician, or specialist physician) and their years of clinical experience (<2, 2-5, or >5 years), analyzed within each study period and with both periods pooled, and in multivariable logistic regression adjusted for study period, body mass index, and tracheal tube size.
Measured: Within 10 minutes after endotracheal tube fixation, before the surgery starts, on the day of surgery (single measurement per patient)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start31 Oct 2026
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for IntubationStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University Pendik Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, betül yüsra şirin, Marmara University Pendik Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07891195
- Sponsor's protocol ID
- 09.2025.25-0526
- Status last verified
- Oct 2026
- First submitted
- 18 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data that support the findings of this study are available from the corresponding author upon reasonable request
Publications
Peng H, Tang Z, Li Y, Zhang W, Duan K, Zheng H, Bo L, Zheng Y, Wu P, Tian J, Han Y, Zou X, Chen G, Xu J, Guan J, Zhang X, Sun J, Shen Y, Zhou M, Zheng S, Wang H, Ma H, Guo Q, Zou W, Weng Y. The investigation of initial endotracheal tube cuff pressures in the operating room: a multi-center cross-sectional study in China. Sci Rep. 2026 Feb 1;16(1):6856. doi: 10.1038/s41598-026-37279-3.
PubMed 41622318Sengupta P, Sessler DI, Maglinger P, Wells S, Vogt A, Durrani J, Wadhwa A. Endotracheal tube cuff pressure in three hospitals, and the volume required to produce an appropriate cuff pressure. BMC Anesthesiol. 2004 Nov 29;4(1):8. doi: 10.1186/1471-2253-4-8.
PubMed 15569386
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Brief Educational Intervention on Endotracheal Tube Cuff Pressure in the Operating Room: A Prospective Pre-Post Study
- ClinicalTrials.gov ID
- NCT07891195
- Acronym / sponsor ID
- 09.2025.25-0526
- Keywords
- cuff pressure, endotracheal tube, cuff manometer, education, educational intervention, before-after study, patient safety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Marmara University Pendik Training and Research HospitalUniversity, hospital or other
- Study start
- 31 Oct 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 23 Oct 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.
Endotracheal tube cuff pressure outside the recommended range of 20-30 cmH₂O is common in routine anesthesia practice. Over-inflation can injure the tracheal mucosa, while under-inflation increases the risk of aspiration and ventilator-associated pneumonia. This prospective, single-center, uncontrolled before-and-after study evaluates whether a brief educational intervention improves cuff pressure management in the operating room. Adult patients undergoing general anesthesia with endotracheal intubation at Marmara University Pendik Training and Research Hospital are enrolled in two consecutive periods. In both periods, cuff pressure is measured with a calibrated manometer shortly after intubation, together with the professional role and clinical experience of the provider who inflated the cuff. Between the two periods, a two-minute educational video explaining the importance of optimal cuff pressure and demonstrating manometer use is distributed to all operating room staff involved in cuff inflation, and reminder posters are placed in every operating room. The primary outcome is the proportion of cuff pressure measurements within the recommended range before versus after the intervention. The secondary outcome is the association between the cuff-inflating provider's role and experience and cuff pressure appropriateness. No change to patient care beyond the educational intervention is made.
Detailed description
This is a prospective, single-center, pre-post interventional study evaluating whether a brief educational intervention improves endotracheal tube cuff pressure management in routine anesthesia practice. Data are collected over four consecutive weeks: a two-week pre-intervention period, followed by the educational intervention and a two-week post-intervention period.
During both periods, cuff inflation is performed according to the routine practice of the healthcare provider; no inflation technique or measurement method is prescribed, and cuff pressure manometers (VBM Medizintechnik, Germany) are available in all operating rooms, but their use is not mandatory. After intubation and tube fixation, cuff pressure is measured by an investigator with a manometer connected to the pilot balloon, without informing the provider who inflated the cuff, in order to reflect usual practice. Values outside 20-30 cmH₂O are recorded and then adjusted to the recommended range. The professional role (anesthesia technician, resident, or specialist physician) and years of clinical experience of the provider, together with patient demographics, type of surgery, and tube size, are recorded.
The intervention consists of a two-minute educational video explaining the importance of maintaining cuff pressure within the recommended range and demonstrating the use of a cuff manometer, distributed to all operating room staff involved in cuff inflation, and a reminder poster displayed in all operating rooms during the post-intervention period.
The proportion of appropriate cuff pressures is compared between periods using the chi-squared test; the association of provider role and experience with appropriate cuff pressure is examined with logistic regression adjusted for study period. Analyses were performed in Phyton 3.13 using pandas 3.0, SciPy 1.18, and statsmodels 0.15. Based on an institutional pilot study of 10 patients, in which 24% of cuff pressure measurements were within the recommended range, 94 patients per period were required to detect an increase to 49% with a two-sided α of 0.05 and 95% power (two-proportion z-test, G*Power 3.1.9.7). Allowing for 10% missing data and for planned subgroup analyses by provider role and experience, 120 patients per period (240 in total) will be enrolled.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pre-intervention period | No intervention | –Patients intubated during the two-week period before the educational intervention; cuff pressure measured according to routine practice. |
| post-interventional period | Experimental | Behavioral: Brief educational intervention (educational video and reminder posters)Patients intubated during the two-week period after operating room staff received the educational intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients aged 18 years or older
- Elective or emergency surgery under general anaesthesia
- Orotracheal intubation with a cuffed endotracheal tube
- Written informed consent
Key exclusion criteria (4 listed)
- Laparoscopic surgery (pneumoperitoneum alters cuff pressure)
- Use of nitrous oxide during anaesthesia (diffusion into the cuff alters cuff pressure)
- Nasotracheal intubation or use of a supraglottic airway device
- Patients already intubated on arrival to the operating room
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 |
|---|---|---|
| Brief educational intervention (educational video and reminder posters)A two-minute educational video explaining the importance of maintaining endotracheal tube cuff pressure within 20-30 cmH₂O, summarising complications of over- and under-inflation, and demonstrating the use of a cuff manometer, distributed via an institutional messaging group to all operating room staff involved in cuff inflation (anaesthesia technicians, resident and specialist physicians). Reminder posters emphasising optimal cuff pressure were displayed in all operating rooms during the post-intervention period. The intervention was directed at healthcare providers, not at patients. | Behavioural | post-interventional period |
Primary outcome
Proportion of patients with endotracheal tube cuff pressure within the recommended range (20-30 cmH₂O)
Time frame: Within 10 minutes after endotracheal tube fixation, before the surgery starts, on the day of surgery (single measurement per patient)
Endotracheal tube cuff pressure measured once by an investigator with a calibrated aneroid cuff manometer (VBM Medizintechnik, Germany) after tube fixation, with the patient supine and before surgical positioning, without informing the provider who inflated the cuff. A pressure of 20-30 cmH₂O is classified as appropriate. The proportion of patients with an appropriate cuff pressure is compared between the pre- and post-intervention periods and expressed as a risk ratio, odds ratio, and absolute difference in proportions with 95% confidence intervals.
1 secondary outcome
Association between the cuff-inflating provider's professional role and clinical experience and cuff pressure appropriateness
Time frame: Within 10 minutes after endotracheal tube fixation, before the surgery starts, on the day of surgery (single measurement per patient)
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 3 Nov 2026.
- Background: PubMed 41622318Peng H, Tang Z, Li Y, Zhang W, Duan K, Zheng H, Bo L, Zheng Y, Wu P, Tian J, Han Y, Zou X, Chen G, Xu J, Guan J, Zhang X, Sun J, Shen Y, Zhou M, Zheng S, Wang H, Ma H, Guo Q, Zou W, Weng Y. The investigation of initial endotracheal tube cuff pressures in the operating room: a multi-center cross-sectional study in China. Sci Rep. 2026 Feb 1;16(1):6856. doi: 10.1038/s41598-026-37279-3.
- Background: PubMed 15569386Sengupta P, Sessler DI, Maglinger P, Wells S, Vogt A, Durrani J, Wadhwa A. Endotracheal tube cuff pressure in three hospitals, and the volume required to produce an appropriate cuff pressure. BMC Anesthesiol. 2004 Nov 29;4(1):8. doi: 10.1186/1471-2253-4-8.
- Individual participant dataSharing planned: No. The data that support the findings of this study are available from the corresponding author upon reasonable request
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief educational intervention (educational video and reminder posters) in people with Intubation and Endotracheal Tube Cuff Pressure, run by Marmara University Pendik 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 4 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 3 Nov 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 Merve Ergenç, MD (+905326309667, hekimoglumerve@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 endotracheal tube cuff pressure within the recommended range (20-30 cmH₂O) (time frame: Within 10 minutes after endotracheal tube fixation, before the surgery starts, on the day of surgery (single measurement per patient)). 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 NCT07891195, which also lists 2 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 3 Nov 2026.