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

Taipei City Hospital ZhongXing Branch, Emergency Department

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.

Study Overview

• Status: Unknown
• Conditions: Intubation Complication; Intubation;Difficult
• Intervention / Treatment: Device: bougie-assisted intubation; Procedure: stylet-assisted epiglottic lifting

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • Taipei City Hospital Zhong-Xing branch
    • Contact: Tzu-Yao Hung, MD; Phone Number: 886-2-979305599; Email: bryansolitude@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• age below 18 year-old

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: bougie-assisted intubation; use bougie as guide, intubation with loading endotracheal tube under direct or video laryngoscopy	Device: bougie-assisted intubation; use bougie as a introducer. Pass the bougie to the trachea and pass the tube via bougie guide.; Other Names: bougie introducer
ACTIVE_COMPARATOR: intubation with epiglottic lifting; Lifting of epiglottis with stylet-equipped endotracheal tube to assist intubation under direct or video laryngoscopy	Procedure: stylet-assisted epiglottic lifting; use stylet-equipped enodtracheal tube to lift the epiglottis and pass the endotracheal tube
NO_INTERVENTION: Traditional intubation; intubation under direct or video laryngoscopy without epiglottis lifting nor bougie-assited

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Taipei City Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2019
• Primary Completion (ANTICIPATED): February 20, 2021
• Study Completion (ANTICIPATED): February 20, 2021

Study Registration Dates

• First Submitted: December 23, 2018
• First Submitted That Met QC Criteria: January 16, 2019
• First Posted (ACTUAL): January 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 19, 2019
• Last Update Submitted That Met QC Criteria: February 15, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: TCHCCT-ZXERRP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No