Simplification and Implementation of Awake Fibreoptic Orotracheal Intubation

NCT03343496 | Completed DMC

• 1 other identifier: B2017-112R
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Trachea; Intubation

Keywords

Awake fiberoptic intubation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Systolic blood pressure, SBP (mmHg)

  During the AFOI

• Diastolic blood pressure, DBP (mmHg)

  During the AFOI

• Heart rate, HR (bpm)

  During the AFOI

• Rate of amnesia of the intubation

  On the first postoperative day

• Ramsay sedation scale

  During the AFOI

Interventions

Awake fiberoptic intubation (AFOI) PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Zhongshan hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Tracheal Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: November 11, 2017
• First Posted: November 17, 2017
• Study Start: November 17, 2017
• Primary Completion: January 30, 2018
• Study Completion: January 30, 2018
• Last Updated: January 25, 2019

Record last verified: 2019-01

Locations

CN (1)