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临床试验/NCT02848365
NCT02848365已完成不适用

Incidence and Severity of Postoperative Sore Throat And Intubation Response by Using Different Devices for Endotracheal Intubation

King Saud University2 个研究点 分布在 1 个国家目标入组 420 人开始时间: 2011年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
420
试验地点
2
主要终点
Incidence of post operative sore throat

研究概览

简要总结

Postoperative sore throat (POST) is a common problem following the use of endotracheal intubation during general anaesthesia. It leads to dissatisfaction and discomfort after surgery and can delay a patient's return to normal routine activities. POST has been rated by patients as the eighth most adverse effect in the postoperative period. The incidence of sore throat after endotracheal intubation varies from 14.4-90%. Laryngoscopy and tracheal intubation also leads to hemodynamic stress response. The response can be deleterious in patient with or without cardiac disease. It is related to the degree of manipulation of the airway during endotracheal intubation and has been studied during intubation for some equipment used for endotracheal intubation

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • After signing of the informed consent,
  • ASA physical status I and II
  • Mallampati class 1& 2,
  • BMI < 35,
  • Undergoing elective surgical procedures (not exceeding two hours in duration) requiring ET intubation

排除标准

  • Patients undergoing day case,
  • bariatric, cardiac, nasal, oral or head & neck surgeries,
  • requiring placement of throat pack or nasogastric/ orogastric tube,
  • patients assigned to rapid sequence induction,
  • hoarseness,
  • patients with anticipated difficult intubation,
  • history of recent upper respiratory tract infection,
  • history of difficult intubation
  • psychiatric disorders hindering proper evaluation,
  • use of steroids (oral or inhalational) or non-steroidal anti-inflammatory drugs within one week of surgery or previous surgery within last two weeks

研究组 & 干预措施

Glidescope

Active Comparator

干预措施: Endotracheal intubation (Device)

Macintosh laryngoscope

Active Comparator

干预措施: Endotracheal intubation (Device)

Bonfill's rigid scope

Active Comparator

干预措施: Endotracheal intubation (Device)

Air traq

Active Comparator

干预措施: Endotracheal intubation (Device)

C -Mac scope

Active Comparator

干预措施: Endotracheal intubation (Device)

flexible fiberoptic scope

Active Comparator

干预措施: Endotracheal intubation (Device)

结局指标

主要结局

Incidence of post operative sore throat

时间窗: 24 hours after surgery

Severity of post operative sore throat

时间窗: 24 hours after surgery

Mean arterial pressure after endotracheal intubation

时间窗: 5 minutes after surgery

次要结局

  • Percentage of glottic opening score (POGO) score(At the time of intubation)
  • Intubation difficulty score(At the time of intubation)
  • cormack Leehanes grade of laryngeal view(At the time of intubation)
  • Patient's satisfaction score(After 24 hours of surgery)

研究者

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

Mansoor Aqil

Professor

King Saud University

研究点 (2)

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