Simplification and Implementation of Awake Fibreoptic Orotracheal Intubation

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.

Study Overview

• Status: Completed
• Conditions: Intubation; Anesthesia; Trachea
• Intervention / Treatment: Procedure: Awake fiberoptic intubation (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 Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Zhongshan Hospital, Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The trial will be performed at Zhongshan Hospital, Fudan University in Shanghai, China.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic blood pressure, SBP (mmHg)	SBP is used to assess hemodynamic fluctuations	During the AFOI
Diastolic blood pressure, DBP (mmHg)	DBP is used to assess hemodynamic fluctuations	During the AFOI
Heart rate, HR (bpm)	HR is used to assess hemodynamic fluctuations	During the AFOI
Rate of amnesia of the intubation	It is used to assess anterograde amnesia of midazolam	On the first postoperative day
Ramsay sedation scale	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	During the AFOI
Patients' satisfaction	1 = excellent, 2 = good, 3 = fair, 4 = poor	On the first postoperative day
Unexpected coughing	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)	During the AFOI
Relative complications	Such as arrhythmias, bleeding or sore throat	End of the surgery and the first postoperative day
Vocal cord movement	1 = open, 2 = moving, 3 = closing, 4 = closed	During the AFOI
Hypoxic episode	SpO2<90%	During the AFOI

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2017
• Primary Completion (Actual): January 30, 2018
• Study Completion (Actual): January 30, 2018

Study Registration Dates

• First Submitted: November 11, 2017
• First Submitted That Met QC Criteria: November 11, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): January 25, 2019
• Last Update Submitted That Met QC Criteria: January 24, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Awake fiberoptic intubation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Tracheal Diseases
• Other Study ID Numbers: B2017-112R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No