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临床试验/NCT01763177
NCT01763177已完成不适用

Use of Oxygen Nebulizer for Preventing Post-operative Sore Throat

Prince of Songkla University2 个研究点 分布在 1 个国家目标入组 1,036 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,036
试验地点
2
主要终点
The effect of oxygen nebulizer therapy on post-operative sore throat

研究概览

简要总结

Rationale: Delivery dry gas during anesthesia is associated with post-operative sore throat (POST). Oxygen nebulizer therapy increases humidity to the airway, especially post-extubation.

Objective: To investigate the effect and complications of oxygen nebulizer therapy on POST.

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)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-75 years
  • Pre-operative Hb >10 g% or Hct > 30%
  • American Society of Anesthesiologist (ASA) class I-III
  • Elective surgery
  • General anesthesia with oroendotracheal tube using Macintosh laryngoscope
  • Not exposed to intraoperative nitrous oxide
  • Oxygen saturation at room air > 95% before induction and at arrival the PACU

排除标准

  • Cases needing ICU admission immediately post-operative
  • Conditioning requiring post-operative oxygen therapy e.g. heart disease, pregnancy, morbid obesity, cardiac and thoracic surgery
  • Patients' conditioning affecting to complication of nebulizer oxygen therapy e.g. pulmonary disease, bleomycin treatment
  • Patient's conditioning affecting POST assessment e.g. pre-operative using ventilator, recent upper respiratory tract infection (URI), recent lower respiratory tract infection and history of difficult airway
  • Surgical conditioning affecting POST e.g. airway surgery, oral surgery, esophageal and neck surgery

结局指标

主要结局

The effect of oxygen nebulizer therapy on post-operative sore throat

时间窗: at post-anesthetic care unit and 24-h post-operative

Assess POST using scoring system and discomfort by interview. Sore throat scoring system is divided into 4 scores 0 means no sore throat 1. means minimal sore throat (less severe than cold) 2. means moderate sore throat (similar to cold) 3. means severe sore throat (more severe than cold)

次要结局

  • To evaluate the adverse events (pulmonary complications, wound infection, and mortality) of post-operative complications related to oxygen therapy(24-h post-op and 30-d mortality)

研究者

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

Panthila Rujirojindakul

Assistant Professor Dr.Panthila Rujirojindakul

Prince of Songkla University

研究点 (2)

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