NCT07485972

Continuous Endotracheal Tube Cuff Pressure Monitoring and Postoperative Airway Complications in Laparoscopic Surgery

Effects of Continuous Endotracheal Tube Cuff Pressure Monitoring on Postoperative Airway Complications in Laparoscopic Surgery: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Cukurova University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This prospective randomized controlled study evaluated the effects of different endotracheal tube cuff pressure monitoring strategies on postoperative airway complications in patients undergoing elective laparoscopic abdominal surgery under general anesthesia. Excessive endotracheal tube cuff pressure may impair tracheal mucosal perfusion and lead to postoperative airway symptoms such as sore throat, cough, dysphagia, hoarseness, and hemoptysis. A total of 95 adult patients (ASA I-II) aged 18-65 years were randomly assigned to one of three groups according to the cuff pressure monitoring technique used during surgery: the cuff-leak technique (control group), intermittent cuff pressure monitoring using a manual manometer every 30 minutes, or continuous cuff pressure monitoring using a pressure transducer connected to the pilot balloon. The primary outcome was the incidence of cuff-related postoperative airway complications at postoperative hours 2 and 24. Secondary outcomes included tracheal mucosal injury assessed by fiberoptic bronchoscopy before extubation and its association with postoperative airway symptoms. The study aimed to determine whether continuous cuff pressure monitoring reduces postoperative airway complications and tracheal mucosal injury compared with intermittent monitoring and the cuff-leak technique.

Detailed description

Endotracheal tube cuff pressure should be maintained between 20 and 30 cmH₂O to ensure adequate ventilation while preventing tracheal mucosal ischemia. Excessive cuff pressure may compromise tracheal mucosal perfusion and lead to postoperative airway complications such as sore throat, cough, hoarseness, dysphagia, and hemoptysis. In laparoscopic surgery, factors such as pneumoperitoneum, patient positioning, and the use of nitrous oxide may contribute to progressive increases in cuff pressure during anesthesia. This prospective randomized controlled trial was conducted to evaluate the impact of different cuff pressure monitoring strategies on postoperative airway complications and tracheal mucosal injury in adult patients undergoing elective laparoscopic abdominal surgery. After obtaining ethical approval and written informed consent, patients were randomized into three groups according to the cuff pressure monitoring method used intraoperatively: cuff inflation using the cuff-leak technique (control group), intermittent cuff pressure monitoring with a manual manometer every 30 minutes, or continuous cuff pressure monitoring using a pressure transducer connected to the pilot balloon. Cuff pressure in the monitored groups was maintained at approximately 25 cmH₂O throughout surgery. Postoperative laryngopharyngeal symptoms, including sore throat, cough, dysphagia, hoarseness, and hemoptysis, were assessed at postoperative hours 2 and 24 by a blinded observer. Tracheal mucosal changes were evaluated using fiberoptic bronchoscopy before extubation and graded according to established criteria. The aim of the study was to determine whether continuous cuff pressure monitoring provides better control of cuff pressure and reduces postoperative airway complications and tracheal mucosal injury compared with intermittent monitoring and the cuff-leak technique.

Conditions

• Postoperative Airway Complications
• Postoperative Sore Throat
• Endotracheal Tube Cuff Pressure

Interventions

Type	Name	Description
PROCEDURE	Intermittent cuff pressure monitoring	Endotracheal tube cuff pressure was adjusted to 25 cmH₂O using a manual manometer and rechecked every 30 minutes during surgery. If the pressure was outside the range of 20-30 cmH₂O, it was readjusted accordingly.
PROCEDURE	Continuous cuff pressure monitoring	Endotracheal tube cuff pressure was continuously monitored using a pressure transducer connected to the pilot balloon via a three-way stopcock and maintained at approximately 25 cmH₂O throughout surgery.
PROCEDURE	Cuff-leak technique	The endotracheal tube cuff was inflated using the cuff-leak technique without objective cuff pressure measurement.

Timeline

• Start date: 2024-05-10
• Primary completion: 2024-10-15
• Completion: 2024-11-08
• First posted: 2026-03-20
• Last updated: 2026-03-20

Locations

1 site across 1 country: Turkey (Türkiye)