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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.

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Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

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Official record

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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
What is being tested?
Brief educational intervention (educational video and reminder posters)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
No sites listed yet
Study dates
19 Oct 2026to Nov 2026
Phase
Interventional

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

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Merve Ergenç, MD contact

+905326309667

hekimoglumerve@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

Background and rationale: Maintaining endotracheal tube cuff pressure within 20-30 cmH₂O is recommended to balance an effective tracheal seal against mucosal perfusion. In everyday practice the cuff is often inflated by palpation of the pilot balloon without manometric measurement, and pressures outside the recommended range are frequent. Low-cost educational interventions may improve adherence, but evidence from routine operating room settings is limited.

Study design and setting: This is a prospective, single-center, uncontrolled before-and-after (quasi-experimental) interventional study conducted in the operating rooms of Marmara University Pendik Training and Research Hospital, a tertiary university hospital in Istanbul, Turkey. The study was approved by the Marmara University Faculty of Medicine Clinical Research Ethics Committee; approval no: 09.2025.25-0526. Written informed consent is obtained from patients. Operating room staff are not informed that cuff pressure is being recorded during the pre-intervention period in order to avoid altering their usual practice; this approach and the anonymous collection of provider data were approved by the ethics committee. The study is reported in accordance with the TREND statement for non-randomized interventional studies.

Participants: Adult patients (≥18 years) undergoing elective surgery under general anesthesia with oral endotracheal intubation are eligible. Patients undergoing laparoscopic surgery, those receiving nitrous oxide, and those intubated with a reinforced (wire-spiral) tracheal tube were excluded, as pneumoperitoneum and nitrous oxide diffusion into the cuff are known to alter cuff pressure, and reinforced tubes differ from standard tubes in cuff design. All eligible patients during each study period are included consecutively, and the study periods were defined in advance.

Data collection: In both periods, cuff pressure is measured once, within 10 minutes after intubation and before surgical positioning, with the patient supine, using a calibrated cuff manometer (VBM Medizintechnik GmbH, Sulz am Neckar, Germany). Measurements are taken by a study investigator who is not involved in the intubation. The professional role (anesthesia technician, resident, or specialist) and years of clinical experience of the person who inflated the cuff, tube size, patient age, sex, and ASA class are recorded. If cuff pressure is outside the recommended range, it is corrected after measurement for patient safety.

Intervention. After the pre-intervention period is completed, a two-minute educational video is distributed to all anesthesia staff involved in cuff inflation via WhatsApp groups. The video explains the clinical consequences of over- and under-inflation, the recommended pressure range and the correct use of a cuff manometer. Reminder posters summarizing the same key messages are displayed in all operating rooms and remain in place throughout the post-intervention period. Post-intervention data collection begins one day after the video is distributed and follows the identical measurement protocol.

Outcomes: The primary outcome is the proportion of cuff pressure measurements within 20-30 cmH₂O compared between the pre- and post-intervention periods. The secondary outcome is the association between the cuff-inflating provider's professional role and clinical experience and cuff pressure appropriateness. Mean cuff pressure and the proportions of over-inflated (>30 cmH₂O) and under-inflated (<20 cmH₂O) measurements are reported descriptively.

Statistical analysis: Categorical variables are compared with the chi-squared or Fisher's exact test and continuous variables with the Mann-Whitney U test, as appropriate. The association of provider role and experience with appropriate cuff pressure is examined with multivariable logistic regression adjusted for study period. Because providers may contribute multiple measurements, a sensitivity analysis accounting for clustering by provider is planned. Two-sided p < 0.05 is considered statistically significant. Analyses were performed in Phyton 3.13 using pandas 3.0, SciPy 1.18 and statsmodels 0.15.

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 groups in NCT07891195
Study groupRoleWhat they receive
pre-education periodNo interventionAdult patients intubated under general anesthesia during the two-week period before the educational intervention. Endotracheal tube cuff inflation was performed according to routine clinical practice; no specific inflation technique or mandatory manometer use was prescribed. Cuff pressure was measured by an investigator with a calibrated manometer shortly after tube fixation, with the patient supine and before surgical positioning, without informing the provider who inflated the cuff.
post-education periodExperimentalAdult patients intubated under general anaesthesia during the two-week period beginning the day after the educational intervention was delivered to operating room staff. The intervention consisted of a two-minute educational video on recommended cuff pressure, complications of over- and under-inflation and cuff manometer use, distributed to all anaesthesia providers involved in cuff inflation, plus reminder posters displayed in all operating rooms throughout the period. Cuff pressure was measured with the identical protocol as in the pre-intervention period.
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.

  1. 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)
  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.

  1. First posted23 Oct 2026
  2. Study start19 Oct 2026 (estimated)
  3. Primary completionNov 2026 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

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)
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
23 Oct 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 41622318
  • Sengupta 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

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