NCT03366311

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

November 27, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 8, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
Last Updated

December 11, 2017

Status Verified

December 1, 2017

Enrollment Period

1 year

First QC Date

November 27, 2017

Last Update Submit

December 8, 2017

Conditions

Airway Complication of AnesthesiaIntubation;Difficult

Keywords

intubationepiglottis lifthold high position

Outcome Measures

Primary Outcomes (1)

  • intubation successful rate

    intubation more than 90 seconds considered as a failed intubation

    through study completion, and average of 15minutes

Secondary Outcomes (3)

  • intubation elapsed time

    through study completion, and average of 15minutes

  • insertion elapsed time

    through study completion, and average of 15minutes

  • difficulty of intubation

    through study completion, and average of 15minutes

Study Arms (3)

holding position

ACTIVE COMPARATOR

different holding position of endotracheal tube

Procedure: holding position

stylet shapes

ACTIVE COMPARATOR

banana shape versus straight-to-cuff shape

Procedure: holding position

epiglottis lift

ACTIVE COMPARATOR

with epiglottis lift or without

Procedure: holding position

Interventions

holding positionPROCEDURE

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

Also known as: shapes of stylet, epiglottis lift
epiglottis liftholding positionstylet shapes

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • care givers with sufficient understanding of airway anatomy and management

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei City Hospital Zhong-Xing branch

Taipei, 100, Taiwan

RECRUITING

Related Publications (1)

  • 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.

    PMID: 30630425DERIVED

Study Officials

  • Tzu-Yao Hung, MD

    Taipei City Hospital ZhongXing Branch

    STUDY DIRECTOR

Central Study Contacts

Tzu-Yao Hung, MD

CONTACT

886-979305599bryansolitude@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Prospective randomised crossover manikin study
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Emergency Medicine Physician

Study Record Dates

First Submitted

November 27, 2017

First Posted

December 8, 2017

Study Start

November 27, 2017

Primary Completion

November 30, 2018

Study Completion

November 30, 2019

Last Updated

December 11, 2017

Record last verified: 2017-12

Locations

TW(1)