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

Not Applicable

• Conditions: Intubation;Difficult; Intubation Complication
• Interventions: Procedure: stylet-assisted epiglottic lifting; Device: bougie-assisted intubation

• Registration Number: NCT03808896
• Lead Sponsor: Taipei City Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-12-23
• Study First Submitted QC: 2019-01-16
• Study First Posted: 2019-01-18
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-15
• Last Update Posted: 2019-02-19
• Study Start: 2019-03-01
• Primary Completion: 2021-02-20
• Study Completion: 2021-02-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• all the patients present to the emergency department with airway emergency who need intubation

Exclusion Criteria

• age below 18 year-old

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intubation with epiglottic lifting	stylet-assisted epiglottic lifting	Lifting of epiglottis with stylet-equipped endotracheal tube to assist intubation under direct or video laryngoscopy
bougie-assisted intubation	bougie-assisted intubation	use bougie as guide, intubation with loading endotracheal tube under direct or video laryngoscopy

Primary Outcome Measures

Name	Time	Method
first pass success rate	through the intubation period, an average of 90 seconds	first pass sucess rate
duration of intubation	through the intubation period, an average of 90 seconds

Secondary Outcome Measures

Name	Time	Method
Immediate complications direct related to intubation process	through the intubation period, an average of 90 seconds	esophageal intubation, bleeding, tracheal perforation
Overall success rate	within 48 hours of intubation	Include all intubation event

Trial Locations

Locations (1)

Taipei City Hospital Zhong-Xing branch; 🇨🇳 Taipei, Taiwan