Effect of a Brief Educational Intervention on Endotracheal Tube Cuff Pressure

NCT07891195 | Not Yet Recruiting

• 1 other identifier: 09.2025.25-0526
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Intubation; Endotracheal Tube Cuff Pressure; Anesthesia; Anesthesia,General

Keywords

cuff pressure; endotracheal tube; cuff manometer; education; educational intervention; before-after study; patient safety

Outcome Measures

Primary Outcomes (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.

  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

  Within 10 minutes after endotracheal tube fixation, before the surgery starts, on the day of surgery (single measurement per patient)

Study Arms (2)

pre-education period

NO INTERVENTION

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.

post-education period

EXPERIMENTAL

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)

Interventions

Brief educational intervention (educational video and reminder posters) BEHAVIORAL

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.

post-education period

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged 18 years or older
• Elective or emergency surgery under general anaesthesia
• Orotracheal intubation with a cuffed endotracheal tube
• Written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University Pendik Training and Research Hospital: lead

Related Publications (2)

• 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.

  PMID: 41622318 BACKGROUND

• 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.

  PMID: 15569386 BACKGROUND

Central Study Contacts

Merve Ergenç, MD

CONTACT

+905326309667; hekimoglumerve@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology and Reanimation Specialist

Study Record Dates

• First Submitted: October 18, 2026
• First Posted: October 23, 2026
• Study Start: October 19, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share