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NCT Number: NCT03343496

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.

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Key information

Conditions

Anesthesia Intubation Respiratory Tract Diseases Trachea Tracheal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongshan hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. The average total time of Awake Fiberoptic Orotracheal Intubation (AFOI)

    Time frame: 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.

    Time frame: End of the AFOI

    All steps are successful once (Percentage)

Secondary outcomes

  1. Systolic blood pressure, SBP (mmHg)

    Time frame: During the AFOI

    SBP is used to assess hemodynamic fluctuations

  2. Diastolic blood pressure, DBP (mmHg)

    Time frame: During the AFOI

    DBP is used to assess hemodynamic fluctuations

  3. Heart rate, HR (bpm)

    Time frame: During the AFOI

    HR is used to assess hemodynamic fluctuations

  4. Rate of amnesia of the intubation

    Time frame: On the first postoperative day

    It is used to assess anterograde amnesia of midazolam

  5. Ramsay sedation scale

    Time frame: 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

    Time frame: On the first postoperative day

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

  7. Unexpected coughing

    Time frame: 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

    Time frame: End of the surgery and the first postoperative day

    Such as arrhythmias, bleeding or sore throat

  9. Vocal cord movement

    Time frame: During the AFOI

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

  10. Hypoxic episode

    Time frame: During the AFOI

    SpO2<90%

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 17, 2017
Registry last updated
Jan 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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