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临床试验/NCT03343496
NCT03343496已完成不适用

Simplification and Implementation of Awake Fibreoptic Orotracheal Intubation

Fudan University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年11月17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
40
试验地点
1
主要终点
The rate of one-time intubation success.

研究概览

简要总结

Awake fibreoptic intubation (AFOI) is a classic and standard method for some special patients which is also difficult for anesthesiologists to learn and master. The procedure is sometimes hard and often takes about 20-30 min. Most of patients have a strong sense of discomfort. Investigators conducted the research to study the simplification and feasibility of AFOI.

详细描述

Many studies have studied the sedative drugs and regional anesthesia related to awake intubation. However, several problems of AFOI are existing including long operation time, patients' strong discomfort, coughing and resistance. And, to investigators' knowledge, there was a lack of a fixed procedure for the implementation of AFOI. Investigators conducted the research and aimed to study the simplification and feasibility of a new AFOI method based on years of clinical theory, practice and experience.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • American Society of Anesthesiologists' physical status I-II patients
  • Aged 18-75 years
  • Mallampati Grade I-II
  • Body Mass Index 18.5-28 kg·m-2

排除标准

  • Allergic to the drugs involved in the study
  • Neck mass or infection
  • Drug or alcohol abuse

结局指标

主要结局

The rate of one-time intubation success.

时间窗: End of the AFOI

All steps are successful once (Percentage)

The average total time of Awake Fiberoptic Orotracheal Intubation (AFOI)

时间窗: End of the AFOI

The time from the midazolam injection to positive end tidal CO2 acquired (Minutes)

次要结局

  • Hypoxic episode(During the AFOI)
  • Ramsay sedation scale(During the AFOI)
  • Systolic blood pressure, SBP (mmHg)(During the AFOI)
  • Diastolic blood pressure, DBP (mmHg)(During the AFOI)
  • Rate of amnesia of the intubation(On the first postoperative day)
  • Patients' satisfaction(On the first postoperative day)
  • Unexpected coughing(During the AFOI)
  • Relative complications(End of the surgery and the first postoperative day)
  • Heart rate, HR (bpm)(During the AFOI)
  • Vocal cord movement(During the AFOI)

研究者

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

Shengjin Ge,MD

Professor of Anesthesiology

Fudan University

研究点 (1)

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