Simplification and Implementation of Awake Fibreoptic Orotracheal Intubation

Study Overview
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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.

Official Title
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Simplification and Implementation of Awake Fibreoptic Orotracheal Intubation

Conditions
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Anesthesia, Trachea, Intubation

Intervention / Treatment
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* Procedure: Awake fiberoptic intubation (AFOI)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic blood pressure, SBP (mmHg) | SBP is used to assess hemodynamic fluctuations | During the AFOI | 
| Diastolic blood pressure, DBP (mmHg) | DBP is used to assess hemodynamic fluctuations | During the AFOI | 
| Heart rate, HR (bpm) | HR is used to assess hemodynamic fluctuations | During the AFOI | 
| Rate of amnesia of the intubation | It is used to assess anterograde amnesia of midazolam | On the first postoperative day | 
| Ramsay sedation scale | 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 | During the AFOI | 
| Patients' satisfaction | 1 = excellent, 2 = good, 3 = fair, 4 = poor | On the first postoperative day | 
| Unexpected coughing | 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) | During the AFOI | 
| Relative complications | Such as arrhythmias, bleeding or sore throat | End of the surgery and the first postoperative day | 
| Vocal cord movement | 1 = open, 2 = moving, 3 = closing, 4 = closed | During the AFOI | 
| Hypoxic episode | SpO2<90% | During the AFOI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Awake fiberoptic intubation