Simplification and Implementation of Awake Fibreoptic Orotracheal Intubation

Completed

• Conditions: Anesthesia; Intubation; Trachea

• Registration Number: NCT03343496
• Lead Sponsor: Fudan University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2017-11-11
• Study First Submitted QC: 2017-11-11
• Study Start: 2017-11-17
• Study First Posted: 2017-11-17
• Primary Completion: 2018-01-30
• Study Completion: 2018-01-30
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-24
• Last Update Posted: 2019-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

1. Allergic to the drugs involved in the study
2. Neck mass or infection
3. Drug or alcohol abuse
4. Pregnant

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The rate of one-time intubation success.	End of the AFOI	All steps are successful once (Percentage)
The average total time of Awake Fiberoptic Orotracheal Intubation (AFOI)	End of the AFOI	The time from the midazolam injection to positive end tidal CO2 acquired (Minutes)

Secondary Outcome Measures

Name	Time	Method
Hypoxic episode	During the AFOI	SpO2\<90%
Systolic blood pressure, SBP (mmHg)	During the AFOI	SBP is used to assess hemodynamic fluctuations
Diastolic blood pressure, DBP (mmHg)	During the AFOI	DBP is used to assess hemodynamic fluctuations
Ramsay sedation scale	During the AFOI	1= anxious or restless or both, 2 = cooperative, orientated and tranquil, 3 = responding to commands, 4 = brisk response to stimulus, 5 = sluggish response to stimulus, 6= No response to stimulus
Rate of amnesia of the intubation	On the first postoperative day	It is used to assess anterograde amnesia of midazolam
Patients' satisfaction	On the first postoperative day	1 = excellent, 2 = good, 3 = fair, 4 = poor
Unexpected coughing	During the AFOI	Unexpected coughing was evaluated with 4 score (1=none, 2\< 3 times unexpected slight coughing comparable to 'clearing ones' throat', 3≥2 times, mild unexpected coughing lasting less than a minute, 4=persistent unexpected coughing)
Relative complications	End of the surgery and the first postoperative day	Such as arrhythmias, bleeding or sore throat
Heart rate, HR (bpm)	During the AFOI	HR is used to assess hemodynamic fluctuations
Vocal cord movement	During the AFOI	1 = open, 2 = moving, 3 = closing, 4 = closed

Trial Locations

Locations (1)

Zhongshan hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China