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Simplification and Implementation of Awake Fibreoptic Orotracheal Intubation

Simplification and Implementation of Awake Fibreoptic Orotracheal Intubation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03343496
Enrollment
40
Registered
2017-11-17
Start date
2017-11-17
Completion date
2018-01-30
Last updated
2019-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Intubation, Trachea

Keywords

Awake fiberoptic intubation

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.

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.

Interventions

PROCEDUREAwake 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.

Sponsors

Fudan University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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

Design outcomes

Primary

MeasureTime frameDescription
The average total time of Awake Fiberoptic Orotracheal Intubation (AFOI)End of the AFOIThe time from the midazolam injection to positive end tidal CO2 acquired (Minutes)
The rate of one-time intubation success.End of the AFOIAll steps are successful once (Percentage)

Secondary

MeasureTime frameDescription
Heart rate, HR (bpm)During the AFOIHR is used to assess hemodynamic fluctuations
Rate of amnesia of the intubationOn the first postoperative dayIt is used to assess anterograde amnesia of midazolam
Ramsay sedation scaleDuring the AFOI1= 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
Patients' satisfactionOn the first postoperative day1 = excellent, 2 = good, 3 = fair, 4 = poor
Systolic blood pressure, SBP (mmHg)During the AFOISBP is used to assess hemodynamic fluctuations
Relative complicationsEnd of the surgery and the first postoperative daySuch as arrhythmias, bleeding or sore throat
Vocal cord movementDuring the AFOI1 = open, 2 = moving, 3 = closing, 4 = closed
Hypoxic episodeDuring the AFOISpO2\<90%
Unexpected coughingDuring the AFOIUnexpected 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)
Diastolic blood pressure, DBP (mmHg)During the AFOIDBP is used to assess hemodynamic fluctuations

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026