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

Primary Purpose

Intubation;Difficult, Intubation Complication

Status

Unknown status

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

stylet-assisted epiglottic lifting

bougie-assisted intubation

About this trial

This is an interventional treatment trial for Intubation;Difficult

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

age below 18 year-old

Sites / Locations

Taipei City Hospital Zhong-Xing branchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

Arm Label

bougie-assisted intubation

intubation with epiglottic lifting

Traditional intubation

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

first pass success rate

first pass sucess rate

duration of intubation

Secondary Outcome Measures

Immediate complications direct related to intubation process

esophageal intubation, bleeding, tracheal perforation

Overall success rate

Include all intubation event

Full Information

NCT ID

NCT03808896

First Posted

December 23, 2018

Last Updated

February 15, 2019

Sponsor

Taipei City Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03808896

Brief Title

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

Official Title

Taipei City Hospital ZhongXing Branch, Emergency Department

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Unknown status

Study Start Date

March 1, 2019 (Anticipated)

Primary Completion Date

February 20, 2021 (Anticipated)

Study Completion Date

February 20, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Taipei City Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intubation;Difficult, Intubation Complication

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

bougie-assisted intubation

Arm Type

Active Comparator

Arm Description

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

Arm Title

intubation with epiglottic lifting

Arm Type

Active Comparator

Arm Description

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

Arm Title

Traditional intubation

Arm Type

No Intervention

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

stylet-assisted epiglottic lifting

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

bougie-assisted intubation

Other Intervention Name(s)

bougie introducer

Intervention Description

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

Primary Outcome Measure Information:

Title

first pass success rate

Description

first pass sucess rate

Time Frame

through the intubation period, an average of 90 seconds

Title

duration of intubation

Time Frame

through the intubation period, an average of 90 seconds

Secondary Outcome Measure Information:

Title

Immediate complications direct related to intubation process

Description

esophageal intubation, bleeding, tracheal perforation

Time Frame

through the intubation period, an average of 90 seconds

Title

Overall success rate

Description

Include all intubation event

Time Frame

within 48 hours of intubation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Taipei City Hospital Zhong-Xing branch

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tzu-Yao Hung, MD

Phone

886-2-979305599

bryansolitude@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

28601269

Citation

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.

Results Reference

background

PubMed Identifier

27843782

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

Results Reference

background

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

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