An interventional study of Brief educational intervention (educational video and reminder posters) in Intubation, Endotracheal Tube Cuff Pressure and Anesthesia, sponsored by Marmara University Pendik Training and Research Hospital. Not yet recruiting. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Marmara University Pendik Training and Research Hospital · Not applicable, Interventional, and Prevention
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.
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.
Marmara University Pendik Training and Research Hospital is the lead sponsor of 34 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Adult 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.
Adult 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.
Behavioral: 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.
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.
Time frame: Within 10 minutes after endotracheal tube fixation, before the surgery starts, on the day of surgery (single measurement per patient)
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.
Time frame: Within 10 minutes after endotracheal tube fixation, before the surgery starts, on the day of surgery (single measurement per patient)
No study locations are listed for this record.
Plan to share: No — The data that support the findings of this study are available from the corresponding author upon reasonable request
Start is estimated for Oct 2026; primary completion for Nov 2026, 1 month later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Marmara University Pendik Training and Research Hospital