TCHCCT-Zhong-Xing-Emergency-Department-airway-clincal (TTC)

Study Overview
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Brief Summary
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In the previous study on mannekin, the investigators found stylet-assisted lifting of epiglottis is an useful technique on difficult airway (Cormack-Lehane grade IIIa, IIIb) without increasing subjective difficulty. It has no expenses other than the routine intubation process. Recently, the studies have proved that the bougie-assisted laryngoscopy can improve first pass intubation rate in the emergency department. However, bougie is a disposable device and may increased medical expenditure. The investigators will evaluate the safety of bougie and epiglottic lifting technique, as well as the first pass and overall success rate of intubation comparing to traditional video laryngoscopy and direct laryngoscopy.

Detailed Description
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A better strategy of managing Cormack-Lehane Grade III had been investigated by our previous study. The investigators' research results had been accepted and published by the journal BioMeidcal Central Anesthesiology. The investigators will be eager to do the further clinical trial to investigate the impact of this technique clinically. Besides, bougie assisted intubation is a effective, evidenced-proved intervention. The investigators will also like to find out the prognosis differences between these two techniques.

Official Title
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Taipei City Hospital ZhongXing Branch, Emergency Department

Conditions
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Intubation;Difficult, Intubation Complication

Intervention / Treatment
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* Procedure: stylet-assisted epiglottic lifting
* Device: bougie-assisted intubation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all the patients present to the emergency department with airway emergency who need intubation Exclusion Criteria: age below 18 year-old

Ages Eligible for Study
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Minimum Age: 18 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Traditional intubation technique direct and video laryngoscope, bougie-assisted intubation, intubation with stylet assisted epiglottis lifting
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: bougie-assisted intubation<br>use bougie as guide, intubation with loading endotracheal tube under direct or video laryngoscopy | Device: bougie-assisted intubation<br>* use bougie as a introducer. Pass the bougie to the trachea and pass the tube via bougie guide.<br>* Other names: bougie introducer;|
| Active Comparator: intubation with epiglottic lifting<br>Lifting of epiglottis with stylet-equipped endotracheal tube to assist intubation under direct or video laryngoscopy | Procedure: stylet-assisted epiglottic lifting<br>* use stylet-equipped enodtracheal tube to lift the epiglottis and pass the endotracheal tube<br>|
| No Intervention: Traditional intubation<br>intubation under direct or video laryngoscopy without epiglottis lifting nor bougie-assited | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| first pass success rate | first pass sucess rate | through the intubation period, an average of 90 seconds | 
| duration of intubation |  | through the intubation period, an average of 90 seconds | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immediate complications direct related to intubation process | esophageal intubation, bleeding, tracheal perforation | through the intubation period, an average of 90 seconds | 
| Overall success rate | Include all intubation event | within 48 hours of intubation |