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临床试验/CTRI/2015/02/005535
CTRI/2015/02/005535尚未招募不适用

THE IMPACT OF TRACHEAL TUBE INTRODUCER GUIDED INTUBATION IN ANTICIPATED NON DIFFICULT AIRWAY ON POST OPERATIVE SORE THROAT

Department of Anaesthesiology Pain Perioperative Medicine1 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2015年2月24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
450
试验地点
1
主要终点
1.To evaluate the impact of tracheal-tube introducer guided intubation on incidence of postoperative sore throat

研究概览

简要总结

Postoperative sore throat (POST) is a longstanding common negative anesthesia outcome after general anesthesia (GA) wherein conventional direct laryngoscopy-intubation (DLI) technique is employed to control upper airway. Various reasons have been placed forth and corresponding measures undertaken (e.g. tracheal tube cuff pressure control) to preclude/diminish the impact of POST but in vain. Till date, none of the efforts to prevent POST have considered mechanical factors associated with DLI as a contributing factor of POST. Since the only ‘active’ mechanical event during upper airway management comprises DLI, we presume that modification of DLI technique will reduce the forces associated with the technique and consequently, bring down incidence/severity of POST. Tracheal tube introducers (TTI), introduced to facilitate intubation in difficult airway settings, have only been employed once to improve quality-of-DLI in non-difficult airway (NDA) settings, that too with limited success. We speculate that the forces related to DLI, including, 1. Laryngoscopic mandibular lift (to expose the glottis-opening), and 2. Frictional forces generated when a tracheal tube passes the vocal cords to get into the trachea; are likely to be lesser when a tracheal-tube is guided inside the trachea with the help of a TTI. This study intends to evaluate the use of TTI in NDA in terms of their ability to bring down the impact of active DLI forces during upper airway access, and consequently, on the incidence of POST.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • ASA physical status I/II 2.Short-to-moderate duration surgery(up to 3-hours)under general anaesthesia with controlled ventilation.

排除标准

  • 1.Anticipated difficult airway.
  • 2.Systemic illness with presenting complaints of sore/dry throat (diabetics with polydipsia, hypertensives on diuretics, moribund bed ridden patients).
  • 3.Neurosurgical patients with active ICP considerations.
  • 4.History of airway related morbidity (POST, mucosal trauma) 5.Recent head and neck, intraoral/nasal surgery.
  • 6.Psychiatric and substance abuse patients.
  • 7.Ongoing upper and lower respiratory tract inflammation/infection.
  • 8.Bleeding diathesis, steroid dependence 9.Consent refusal.

结局指标

主要结局

1.To evaluate the impact of tracheal-tube introducer guided intubation on incidence of postoperative sore throat

时间窗: From arrival in the postoperative recovery room till 24 hours

次要结局

  • 1.Intubation attempts(2.Laryngoscopy-intubation time)

研究者

发起方
Department of Anaesthesiology Pain Perioperative Medicine
申办方类型
Research institution and hospital

研究点 (1)

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