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

NCT03808896 | Unknown

• 1 other identifier: TCHCCT-ZXERRP
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Intubation;Difficult; Intubation Complication

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Immediate complications direct related to intubation process

  through the intubation period, an average of 90 seconds

• Overall success rate

  within 48 hours of intubation

Study Arms (3)

bougie-assisted intubation

ACTIVE COMPARATOR

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

Device: bougie-assisted intubation

intubation with epiglottic lifting

ACTIVE COMPARATOR

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

Procedure: stylet-assisted epiglottic lifting

Traditional intubation

NO INTERVENTION

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

Interventions

stylet-assisted epiglottic lifting PROCEDURE

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

intubation with epiglottic lifting

bougie-assisted intubation DEVICE

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

Also known as: bougie introducer

bougie-assisted intubation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• age below 18 year-old

Sponsors & Collaborators

• Taipei City Hospital: lead

Study Sites (1)

Taipei City Hospital Zhong-Xing branch

Taipei, 100, Taiwan

RECRUITING

Related 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.

  PMID: 28601269 BACKGROUND

• 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.

  PMID: 27843782 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of emergency department

Model Details: Traditional intubation technique direct and video laryngoscope, bougie-assisted intubation, intubation with stylet assisted epiglottis lifting

Study Record Dates

• First Submitted: December 23, 2018
• First Posted: January 18, 2019
• Study Start: March 1, 2019
• Primary Completion: February 20, 2021
• Study Completion: February 20, 2021
• Last Updated: February 19, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)