Clincosm LogoSign in Get a demo

Simplification and Implementation of Awake Fibreoptic Orotracheal Intubation

Sponsor
Fudan University (Other)
Overall Status
Completed
CT.gov ID
NCT03343496
Collaborator
(none)
40
Enrollment
1
Location
2.4
Actual Duration (Months)
16.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
40 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Simplification and Implementation of Awake Fibreoptic Orotracheal Intubation
Actual Study Start Date :
Nov 17, 2017
Actual Primary Completion Date :
Jan 30, 2018
Actual Study Completion Date :
Jan 30, 2018

Outcome Measures

Primary Outcome Measures

  1. 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)

  2. The rate of one-time intubation success. [End of the AFOI]

    All steps are successful once (Percentage)

Secondary Outcome Measures

  1. Systolic blood pressure, SBP (mmHg) [During the AFOI]

    SBP is used to assess hemodynamic fluctuations

  2. Diastolic blood pressure, DBP (mmHg) [During the AFOI]

    DBP is used to assess hemodynamic fluctuations

  3. Heart rate, HR (bpm) [During the AFOI]

    HR is used to assess hemodynamic fluctuations

  4. Rate of amnesia of the intubation [On the first postoperative day]

    It is used to assess anterograde amnesia of midazolam

  5. 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

  6. Patients' satisfaction [On the first postoperative day]

    1 = excellent, 2 = good, 3 = fair, 4 = poor

  7. 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)

  8. Relative complications [End of the surgery and the first postoperative day]

    Such as arrhythmias, bleeding or sore throat

  9. Vocal cord movement [During the AFOI]

    1 = open, 2 = moving, 3 = closing, 4 = closed

  10. Hypoxic episode [During the AFOI]

    SpO2<90%

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zhongshan hospital, Fudan University Shanghai Shanghai China 200032

Sponsors and Collaborators

  • Fudan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shengjin Ge,MD, Professor of Anesthesiology, Fudan University
ClinicalTrials.gov Identifier:
NCT03343496
Other Study ID Numbers:
  • B2017-112R
First Posted:
Nov 17, 2017
Last Update Posted:
Jan 25, 2019
Last Verified:
Jan 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Shengjin Ge,MD, Professor of Anesthesiology, Fudan University
Awake fiberoptic intubation
Additional relevant MeSH terms:
Tracheal Diseases

Study Results

No Results Posted as of Jan 25, 2019