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临床试验/NCT04779528
NCT04779528已完成不适用

Awake Nasal Fiber-optic Intubation of Severely Obese Patients in Lateral Position: a Prospective Randomized Controlled Trial

University of Jordan2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Duration of fiberoptic intubation.

研究概览

简要总结

Airway management in severely obese patients remains a challenging issue for anesthetists and may lead to life-threatening situations. Awake Fiber-Optic Bronchoscopy Intubation (FOBI) technique is considered as the gold standard when a difficult airway is anticipated to secure the airway and to facilitate the surgery. FOBI is usually done in supine position, while (in conscious patients) lateral position is the most recommended position to keep the upper airway patent. This prospective clinical trial study will test whether awake FOBI in Lateral position will provide a safe profile or a significant advantage over FOBI in supine position, in morbidly obese patients undergoing elective bariatric surgery.

详细描述

Airway management in severely obese patients remains a challenging issue for anesthetists and may lead to life-threatening situations. Awake Fiber-Optic Bronchoscopy Intubation (FOBI) technique is considered as the gold standard when a difficult airway is anticipated to secure the airway and to facilitate the surgery. FOBI is usually done in supine position, while (in conscious patients) lateral position is the most recommended position to keep the upper airway patent.

This prospective clinical trial study will test whether awake FOBI in Lateral position will provide a safe profile or a significant advantage over FOBI in supine position, in morbidly obese patients undergoing elective bariatric surgery. The main outcome is success rate and duration of the procedure. Secondary outcomes are oxygenation maintenance, hemodynamic stability, airway complication, sedation score, and postoperative airway morbidity in 6 hours after surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

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

  • American Society of Anesthesiologists physical status classification two and three.
  • Patients scheduled for elective bariatric surgeries under general anesthesia.

排除标准

  • Refusal of fiberoptic intubation.
  • Allergy to local anesthetics.
  • Coagulopathy.
  • Raised intracranial or intraocular pressure.

结局指标

主要结局

Duration of fiberoptic intubation.

时间窗: 5 minutes

The investigators will compare between the supine and lateral positions in terms of the duration needed for the insertion of an endotracheal tube via fiberoptic intubation.

次要结局

  • Complications during airway manipulation.(5 minutes)

研究者

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

omar ahmad ababneh

Principal investigator

University of Jordan

研究点 (2)

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