Effect of continuous measurement and adjustment of endotracheal tube cuff pressure on postoperative sore throat in patients undergoing gynecological laparoscopic surgery: study protocol for a randomized controlled trial.

BACKGROUND

Postoperative sore throat (POST) is a common postoperative complication after endotracheal tube removal. There are still no effective preventive methods for POST. The aim of this trial is to confirm whether maintaining intraoperative cuff pressure below the tracheal capillary perfusion pressure could effectively reduce the incidence of POST among patients undergoing gynecological laparoscopic surgery.

METHODS

This study is a single-center, randomized, parallel-controlled, superiority trial with a 1:1 allocation ratio. Sixty patients whose age is between 18 and 65 years and scheduled for gynecological laparoscopic surgery will be randomized to the cuff pressure measurement and adjustment (CPMA) group and the only cuff pressure measurement without adjustment group (control group). The primary endpoint is the incidence of sore throat at rest within 24 h after extubation. The secondary endpoints include the incidence of cough, the incidence of hoarseness, the incidence of postoperative nausea and vomiting (PONV), POST, and pain intensity within 24 h after extubation. Blocked randomization will be conducted with a computer-generated central randomization online service. The blind method will be applied to subjects, data collectors, outcome evaluators, and statisticians. Outcome assessments will be performed at 0 h and 24 h post-extubation.

DISCUSSION

This randomized controlled study hypothesizes that cuff pressure is the primary influencing factor of POST. By continuous monitoring of endotracheal tube cuff pressure and maintaining it within the range of 18-22 mmHg compared with only continuous measurement without adjustment, it aims to prove that continuous measurement and adjustment of endotracheal tube cuff pressure could be effective in reducing the incidence of POST in gynecological laparoscopic surgery patients. The result of this study could be used as a reference for future multicenter studies to confirm the effect of cuff pressure on POST and provides a scientific theoretical basis for preventing POST to further support comfort medicine.

TRIAL REGISTRATION

Chinese Clinical Trial Registry ChiCTR2200064792. Registered on 18 October 2022. This protocol (version 1.0, 16 March 2022) was approved by the Ethics Committee of Beijing Chaoyang Hospital.