Simplification and Implementation of Awake Fibreoptic Orotracheal Intubation

NCT ID: NCT03343496

Last Updated: 2019-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-17

Study Completion Date

2018-01-30

Brief Summary

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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

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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.

Conditions

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Anesthesia Trachea Intubation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Shengjin Ge,MD

Professor of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zhongshan hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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B2017-112R

Identifier Type: -

Identifier Source: org_study_id

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