Simplification and Implementation of Awake Fibreoptic Orotracheal Intubation

Anesthesia Clinical Trial

Official title:

Simplification and Implementation of Awake Fibreoptic Orotracheal Intubation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03343496
• Other study ID #: B2017-112R
• Status: Completed
• Start date: November 17, 2017
• Est. completion date: January 30, 2018

Study information

• Verified date: January 2019
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 30, 2018
• Est. primary completion date: January 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Intubation
• Trachea

Intervention

Procedure:
• Awake fiberoptic intubation (AFOI)
With forty patients (ASA I~II, aged 18~75, simulating cervical instability injury) recruited to be operated on under general anesthesia, two experienced anesthesiologists performed the whole procedures within the study. Pre anesthetic interview was taken to illustrate the procedures of tracheal intubation to the patients. The simplified method consisted of three parts: conscious sedation, regional anesthesia and intubation. The time of AFOI, rate of one-time intubation success, hemodynamic parameters, pulse oxygen saturation (SpO2), rate of amnesia of the intubation, patients' satisfaction, and relative complications were recorded accordingly.

Locations

Country	Name	City	State
China	Zhongshan hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	The rate of one-time intubation success.	All steps are successful once (Percentage)	End of the AFOI
Secondary	Systolic blood pressure, SBP (mmHg)	SBP is used to assess hemodynamic fluctuations	During the AFOI
Secondary	Diastolic blood pressure, DBP (mmHg)	DBP is used to assess hemodynamic fluctuations	During the AFOI
Secondary	Heart rate, HR (bpm)	HR is used to assess hemodynamic fluctuations	During the AFOI
Secondary	Rate of amnesia of the intubation	It is used to assess anterograde amnesia of midazolam	On the first postoperative day
Secondary	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
Secondary	Patients' satisfaction	1 = excellent, 2 = good, 3 = fair, 4 = poor	On the first postoperative day
Secondary	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
Secondary	Relative complications	Such as arrhythmias, bleeding or sore throat	End of the surgery and the first postoperative day
Secondary	Vocal cord movement	1 = open, 2 = moving, 3 = closing, 4 = closed	During the AFOI
Secondary	Hypoxic episode	SpO2<90%	During the AFOI