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

NCT ID: NCT03808896

Last Updated: 2019-02-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2021-02-20

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.

Conditions

Intubation;Difficult; Intubation Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

bougie-assisted intubation

use bougie as guide, intubation with loading endotracheal tube under direct or video laryngoscopy

Group Type: ACTIVE_COMPARATOR

bougie-assisted intubation

Intervention Type: DEVICE

use bougie as a introducer. Pass the bougie to the trachea and pass the tube via bougie guide.

intubation with epiglottic lifting

Lifting of epiglottis with stylet-equipped endotracheal tube to assist intubation under direct or video laryngoscopy

Group Type: ACTIVE_COMPARATOR

stylet-assisted epiglottic lifting

Intervention Type: PROCEDURE

use stylet-equipped enodtracheal tube to lift the epiglottis and pass the endotracheal tube

Traditional intubation

intubation under direct or video laryngoscopy without epiglottis lifting nor bougie-assited

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

stylet-assisted epiglottic lifting

use stylet-equipped enodtracheal tube to lift the epiglottis and pass the endotracheal tube

Intervention Type: PROCEDURE

bougie-assisted intubation

use bougie as a introducer. Pass the bougie to the trachea and pass the tube via bougie guide.

Intervention Type: DEVICE

Other Intervention Names

bougie introducer

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• age below 18 year-old

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei City Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Hung,Tzu-Yao

Director of emergency department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Taipei City Hospital Zhong-Xing branch

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Facility Contacts

Tzu-Yao Hung, MD

Role: primary

bryansolitude@gmail.com

886-2-979305599

References

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.

Reference Type: BACKGROUND

PMID: 28601269 (View on PubMed)

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. doi: 10.5812/aapm.38507. eCollection 2016 Aug.

Reference Type: BACKGROUND

PMID: 27843782 (View on PubMed)

Other Identifiers

TCHCCT-ZXERRP

Identifier Type: -

Identifier Source: org_study_id