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

Intubation Complication Clinical Trial

Official title:

Taipei City Hospital ZhongXing Branch, Emergency Department

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03808896
• Other study ID #: TCHCCT-ZXERRP
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: February 20, 2021

Study information

• Verified date: February 2019
• Source: Taipei City Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 20, 2021
• Est. primary completion date: February 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• age below 18 year-old

Related Conditions & MeSH terms

• Emergencies
• Intubation Complication
• Intubation;Difficult

Intervention

Procedure:
• stylet-assisted epiglottic lifting
use stylet-equipped enodtracheal tube to lift the epiglottis and pass the endotracheal tube

Device:
• bougie-assisted intubation
use bougie as a introducer. Pass the bougie to the trachea and pass the tube via bougie guide.

Locations

Country	Name	City	State
Taiwan	Taipei City Hospital Zhong-Xing branch	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei City Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

Driver B, Dodd K, Klein LR, Buckley R, Robinson A, McGill JW, Reardon RF, Prekker ME. The Bougie and First-Pass Success in the Emergency Department. Ann Emerg Med. 2017 Oct;70(4):473-478.e1. doi: 10.1016/j.annemergmed.2017.04.033. — View Citation

Ueda W, Arai YP. The Use of a Stylet to Aid the Lifting of the Epiglottis With a Video Laryngoscope. Anesth Pain Med. 2016 May 24;6(4):e38507. eCollection 2016 Aug. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	first pass success rate	first pass sucess rate	through the intubation period, an average of 90 seconds
Primary	duration of intubation		through the intubation period, an average of 90 seconds
Secondary	Immediate complications direct related to intubation process	esophageal intubation, bleeding, tracheal perforation	through the intubation period, an average of 90 seconds
Secondary	Overall success rate	Include all intubation event	within 48 hours of intubation