跳至主要内容
临床试验/NCT07485972
NCT07485972已完成不适用

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

Cukurova University1 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2024年5月10日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
95
试验地点
1
主要终点
Incidence of postoperative airway complications

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

Outcome assessments were performed by an independent investigator who was blinded to group allocation.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18-65 years
  • ASA physical status I-II
  • Scheduled for elective laparoscopic abdominal surgery under general anesthesia
  • Expected surgery duration longer than 90 minutes

排除标准

  • Predicted difficult airway
  • Recent upper respiratory tract infection
  • Preoperative laryngopharyngeal symptoms
  • Recent endotracheal intubation
  • Body mass index > 40 kg/m²
  • Substance abuse
  • History of bronchospasm
  • Tracheostomy
  • History of laryngeal disease or laryngeal surgery
  • ASA physical status ≥ III

结局指标

主要结局

Incidence of postoperative airway complications

时间窗: Postoperative 2 hours and 24 hours

The incidence of postoperative airway complications including sore throat, cough, dysphagia, hoarseness, and hemoptysis assessed at postoperative hours 2 and 24.

次要结局

  • Tracheal mucosal injury assessed by fiberoptic bronchoscopy(Before extubation (end of surgery))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fevzi Güler

Resident Physician, Department of Anesthesiology and Reanimation

Cukurova University

研究点 (1)

Loading locations...

相似试验