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COMPLETED
NCT07842081
NA

Scheduled Endotracheal Tube Cuff Pressure Management and Postoperative Sore Throat

Sponsor: Hitit University

View on ClinicalTrials.gov

Summary

This randomized controlled trial evaluated whether scheduled measurement and adjustment of endotracheal tube cuff pressure using a handheld manometer could reduce postoperative sore throat in adults undergoing elective surgery under general anesthesia with tracheal intubation. Participants were randomly assigned in a 1:1 ratio to either manometer-guided cuff-pressure management or conventional cuff inflation based on pilot-balloon palpation. In the manometer-guided group, cuff pressure was maintained within a target range of 25-30 cmH₂O. In the conventional group, cuff inflation was managed according to the attending anesthesiologist's usual clinical assessment. Cuff pressure was assessed at predefined time points during anesthesia. Postoperative sore throat was evaluated at 1, 6, and 24 hours after extubation. Other postoperative airway symptoms, including hoarseness, difficulty swallowing, cough, and postoperative nausea or vomiting, were also assessed. The main objective was to determine whether scheduled manometer-guided cuff-pressure management reduced the occurrence of postoperative sore throat within the first 24 hours after surgery compared with conventional pilot-balloon palpation.

Official title: Scheduled Manometer-Guided Endotracheal Tube Cuff-Pressure Management Versus Pilot-Balloon Palpation for Reducing Postoperative Sore Throat in Adults Undergoing Elective Surgery With Tracheal Intubation: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

126

Start Date

2025-05-13

Completion Date

2025-11-18

Last Updated

2026-09-25

Healthy Volunteers

No

Interventions

DEVICE

Handheld Endotracheal Tube Cuff Manometer

Endotracheal tube cuff pressure was measured using a handheld cuff manometer and adjusted to a target range of 25-30 cmH₂O. Measurements were performed immediately after intubation, 10 minutes after intubation, 1 hour after intubation, and immediately before extubation.

PROCEDURE

Pilot-Balloon Palpation

Endotracheal tube cuff inflation was managed according to the attending anesthesiologist's subjective assessment of the pilot balloon. Cuff pressure was measured at the predefined study time points for study documentation only, without pressure-directed adjustment.

Locations (1)

Hitit University Erol Olçok Training and Research Hospital

Çorum, Turkey (Türkiye)