Back to results

TCHCCT-Zhong-Xing-Emergency-Department-airway (TT)

Primary Purpose

Airway Complication of Anesthesia, Intubation;Difficult

Status

Unknown status

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

holding position

About this trial

This is an interventional treatment trial for Airway Complication of Anesthesia focused on measuring intubation, epiglottis lift, hold high position

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

care givers with sufficient understanding of airway anatomy and management

Exclusion Criteria:

Sites / Locations

Taipei City Hospital Zhong-Xing branchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

holding position

stylet shapes

epiglottis lift

Arm Description

different holding position of endotracheal tube

banana shape versus straight-to-cuff shape

with epiglottis lift or without

Outcomes

Primary Outcome Measures

intubation successful rate

intubation more than 90 seconds considered as a failed intubation

Secondary Outcome Measures

intubation elapsed time

from insertion of endotracheal to the tube until proper placement of endotracheal tube

insertion elapsed time

from proper glottic view to the tube until proper placement of endotracheal tube

difficulty of intubation

Visual Analogue Scale with a 10cm bar

Full Information

NCT ID

NCT03366311

First Posted

November 27, 2017

Last Updated

December 8, 2017

Sponsor

Taipei City Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03366311

Brief Title

TCHCCT-Zhong-Xing-Emergency-Department-airway

Acronym

Official Title

TCH-Zhong-Xing-Branch-Emergency-Department

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Unknown status

Study Start Date

November 27, 2017 (Actual)

Primary Completion Date

November 30, 2018 (Anticipated)

Study Completion Date

November 30, 2019 (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

To investigate which shapes of stylet, hand techniques and possible condition that improve intubation successful rate and reduce the elapsed intubation time.

Detailed Description

Challenging airway is always a big issue in emergency room. However, better hand technique, stylet shapes and conditions affecting intubation successful rate, elapsed duration need further investigations. We compare two endotracheal tube holding position, two holding places, with or without epiglottis lift technique in this study. All intubation processes in the study will be recorded.

6. Conditions and Keywords

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

Airway Complication of Anesthesia, Intubation;Difficult

Keywords

intubation, epiglottis lift, hold high position

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

Prospective randomised crossover manikin study

Masking

Participant

Allocation

Randomized

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

holding position

Arm Type

Active Comparator

Arm Description

different holding position of endotracheal tube

Arm Title

stylet shapes

Arm Type

Active Comparator

Arm Description

banana shape versus straight-to-cuff shape

Arm Title

epiglottis lift

Arm Type

Active Comparator

Arm Description

with epiglottis lift or without

Intervention Type

Procedure

Intervention Name(s)

holding position

Other Intervention Name(s)

shapes of stylet, epiglottis lift

Intervention Description

two types of holding positions plus two types of shapes of stylet, with or without epiglottis lift

Primary Outcome Measure Information:

Title

intubation successful rate

Description

intubation more than 90 seconds considered as a failed intubation

Time Frame

through study completion, and average of 15minutes

Secondary Outcome Measure Information:

Title

intubation elapsed time

Description

from insertion of endotracheal to the tube until proper placement of endotracheal tube

Time Frame

through study completion, and average of 15minutes

Title

insertion elapsed time

Description

from proper glottic view to the tube until proper placement of endotracheal tube

Time Frame

through study completion, and average of 15minutes

Title

difficulty of intubation

Description

Visual Analogue Scale with a 10cm bar

Time Frame

through study completion, and average of 15minutes

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: care givers with sufficient understanding of airway anatomy and management Exclusion Criteria: N/A

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tzu-Yao Hung, MD

Phone

886-979305599

bryansolitude@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tzu-Yao Hung, MD

Organizational Affiliation

Taipei City Hospital ZhongXing Branch

Official's Role

Study Director

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

12. IPD Sharing Statement

Citations:

PubMed Identifier

30630425

Citation

Hung TY, Lin LW, Yeh YH, Su YC, Lin CH, Yang TF. The evaluation of a better intubation strategy when only the epiglottis is visible: a randomized, cross-over mannequin study. BMC Anesthesiol. 2019 Jan 10;19(1):8. doi: 10.1186/s12871-018-0663-9.

Results Reference

derived

Learn more about this trial

TCHCCT-Zhong-Xing-Emergency-Department-airway

We'll reach out to this number within 24 hrs