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临床试验/CTRI/2025/05/087382
CTRI/2025/05/087382尚未招募不适用

A single-centre, prospective, two-arm, observational study to investigate the causative factors of postoperative sore throat (POST) and assess whether maintaining endotracheal tube cuff pressure between 20-30 cm H2O and supraglottic airway device cuff pressure up to 60 cm H2O influences the incidence of POST.

Bhaktivedanta Hospital and Research Institute1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年4月6日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
A comparison of postoperative sore throat (POST) incidence between Group A, where cuff pressure is actively monitored, and Group B, which follows standard practice without cuff pressure monitoring.

研究概览

简要总结

Postoperative sore throat (POST) is a common complication after general anaesthesia, often due to mucosal injury from airway devices, leading to discomfort and delayed recovery. This study aims to evaluate the relationship between perioperative factors and POST, and whether maintaining endotracheal tube cuff pressures between 20–30 cm H2O and supraglottic airway device pressures up to 60 cm H2O reduces its incidence. Adult patients over 18 years undergoing surgeries under general anaesthesia with ASA Grade 1 or 2 status will be included, while those with pre-existing throat conditions, undergoing specific throat surgeries, or requiring postoperative ventilation will be excluded. Patients will be divided into two groups: one with continuous cuff pressure monitoring and one with standard practice. The study will record demographics, medical history, anaesthesia details, and postoperative outcomes over one year with a total sample size of 50 patients. The primary endpoint is to compare the incidence of POST between the two groups, and the secondary endpoint is to assess the influence of perioperative variables on POST occurrence.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • All patients of all genders above 18 years of age
  • Patients who are schedule for surgery and require general anaesthesia with use of either endotracheal tube or supraglottic airway device.
  • All ASA Grade 1 and ASA Grade 2 patients included.
  • (ASA= American Association of Anaesthesiologists).

排除标准

  • Patient with pre-existing sore throat due to vocal cord polyp or vocal cord growth or oral-throat cancerous growth / thyroid swelling/ tonsillitis/ no reason
  • Patients undergoing following surgeries, not be included- Micro-laryngoscopy or DL scopies for vocal cord polyp or growth and Oral-Throat cancer surgeries
  • Drowsy patient / Patients with poor General Condition/ Mentally challenged were excluded
  • Patients who required postoperative ventilator or who were shifted on T-piece excluded.

结局指标

主要结局

A comparison of postoperative sore throat (POST) incidence between Group A, where cuff pressure is actively monitored, and Group B, which follows standard practice without cuff pressure monitoring.

时间窗: within 24 hours and at the time of discharge

次要结局

  • To assess the relationship between key perioperative variables (such as intubation time, tube size, and anesthesia management) and the occurrence of postoperative sore throat (POST) in both groups.(after one year)

研究者

发起方
Bhaktivedanta Hospital and Research Institute
申办方类型
Research institution and hospital

研究点 (1)

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