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TT: TCHCCT-Zhong-Xing-Emergency-Department-airway

Sponsor
Taipei City Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03366311
Collaborator
(none)
45
Enrollment
1
Location
3
Arms
24.1
Anticipated Duration (Months)
1.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: holding position
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Prospective randomised crossover manikin studyProspective randomised crossover manikin study
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
TCH-Zhong-Xing-Branch-Emergency-Department
Actual Study Start Date :
Nov 27, 2017
Anticipated Primary Completion Date :
Nov 30, 2018
Anticipated Study Completion Date :
Nov 30, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: holding position

different holding position of endotracheal tube

Procedure: holding position
two types of holding positions plus two types of shapes of stylet, with or without epiglottis lift
Other Names:
  • shapes of stylet
  • epiglottis lift

    		•
    Active Comparator: stylet shapes

    banana shape versus straight-to-cuff shape

    Procedure: holding position
    two types of holding positions plus two types of shapes of stylet, with or without epiglottis lift
    Other Names:
  • shapes of stylet
  • epiglottis lift

    		•
    Active Comparator: epiglottis lift

    with epiglottis lift or without

    Procedure: holding position
    two types of holding positions plus two types of shapes of stylet, with or without epiglottis lift
    Other Names:
  • shapes of stylet
  • epiglottis lift

    		•

    Outcome Measures

    Primary Outcome Measures

    1. intubation successful rate [through study completion, and average of 15minutes]

      intubation more than 90 seconds considered as a failed intubation

    Secondary Outcome Measures

    1. intubation elapsed time [through study completion, and average of 15minutes]

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

    2. insertion elapsed time [through study completion, and average of 15minutes]

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

    3. difficulty of intubation [through study completion, and average of 15minutes]

      Visual Analogue Scale with a 10cm bar

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • care givers with sufficient understanding of airway anatomy and management
    Exclusion Criteria:
    • N/A

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Taipei City Hospital Zhong-Xing branch Taipei Taiwan 100

    Sponsors and Collaborators

    • Taipei City Hospital

    Investigators

    • Study Director: Tzu-Yao Hung, MD, Taipei City Hospital ZhongXing Branch

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hung,Tzu-Yao, Emergency Medicine Physician, Taipei City Hospital
    ClinicalTrials.gov Identifier:
    NCT03366311
    Other Study ID Numbers:
    • TCHCCT-ZXER
    First Posted:
    Dec 8, 2017
    Last Update Posted:
    Dec 11, 2017
    Last Verified:
    Dec 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hung,Tzu-Yao, Emergency Medicine Physician, Taipei City Hospital
    intubation
    epiglottis lift
    hold high position
    Additional relevant MeSH terms:
    Emergencies

    Study Results

    No Results Posted as of Dec 11, 2017