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Effect of Modified Stylet Angulation on the Intubation With GlideScope® (GlideMStylet)

Primary Purpose

Cholecystitis, Stomach Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Glidescope guided intubation
GlideScope®
Sponsored by
Keimyung University Dongsan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholecystitis focused on measuring intubation, stylet, videolaryngoscope

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients requiring endotracheal intubation for general anesthesia

Exclusion Criteria:

  • Difficult airway
  • Rapid sequence induction
  • Recent sore throat
  • Fragile teeth
  • Contraindication for videolaryngoscope
  • Head and neck surgery

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    90 degree

    70 degree

    Arm Description

    The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end.

    The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle.

    Outcomes

    Primary Outcome Measures

    Time to Intubation
    Time from the insertion of the Glidescope blade to the measurement of end tidal CO2 (>30 mmHg)

    Secondary Outcome Measures

    Success Rate of Intubation
    The number of patients in which the intubation was successful at the first time.
    Difficulty of Intubation Measured Using Visual Analogue Scale
    Difficulty of intubation will be measured using visual analogue scale (0:easiest, 100:most difficult).
    Number of Participants for Whom External Laryngeal Manipulation Was Necessary
    External laryngeal manipulation is defined as the compression of neck for the facilitation of laryngeal view. Number of participants for whom external laryngeal manipulation was necessary will be measured.
    Cormack-Lehan Grade
    The grade of Cormack-Lehan was assessed as I/II/III/IV (I: Full view of glottis, II: Partial view of glottis, III: Only epiglottis seen, none of glottis seen, IV: Neither glottis nor epiglottis seen). Grade I was considered better outcomes.
    Mallampati Grade
    The Mallapati grade was assessed as I/II/III/IV (I: Soft palate, uvula, fauces, pillars visible, II: Soft palate, uvula, fauces visible, III: Soft palate, base of uvula visible, IV: Only hard palate visible). Grade I was considered better outcomes.
    Thyromental Distance
    The thyromental distance was measured.
    Postoperative Sore Throat Measured Using Visual Analogue Scale
    Postoperative sore throat will be measured using visual analogue scale (0:no pain, 100: worst pain imaginable)
    Mean Blood Pressure
    Mean blood pressure is measured before and 2 min after intubation.
    Heart Rate
    Heart rates are measured before and 2 min after intubation.
    Airway Injury
    Larynx injury is assessed.

    Full Information

    First Posted
    September 1, 2015
    Last Updated
    June 7, 2017
    Sponsor
    Keimyung University Dongsan Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02547064
    Brief Title
    Effect of Modified Stylet Angulation on the Intubation With GlideScope®
    Acronym
    GlideMStylet
    Official Title
    Stylet Angulation of Seventy Degrees Reduced Time to Intubation With the GlideScope®: A Prospective Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2015 (undefined)
    Primary Completion Date
    January 2016 (Actual)
    Study Completion Date
    January 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Keimyung University Dongsan Medical Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The GlideScope® videolaryngoscope usually visualize glottis better than the conventional laryngoscope. Under the visualization of glottis by GlideScope®, the insertion of endotracheal tube, however, is challenging. The goal of this study was to determine which of two stylet (70° vs 90°) was better, as determined by time to intubation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cholecystitis, Stomach Cancer
    Keywords
    intubation, stylet, videolaryngoscope

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    162 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    90 degree
    Arm Type
    Active Comparator
    Arm Description
    The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end.
    Arm Title
    70 degree
    Arm Type
    Experimental
    Arm Description
    The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle.
    Intervention Type
    Procedure
    Intervention Name(s)
    Glidescope guided intubation
    Intervention Type
    Device
    Intervention Name(s)
    GlideScope®
    Primary Outcome Measure Information:
    Title
    Time to Intubation
    Description
    Time from the insertion of the Glidescope blade to the measurement of end tidal CO2 (>30 mmHg)
    Time Frame
    Intraoperative intubation
    Secondary Outcome Measure Information:
    Title
    Success Rate of Intubation
    Description
    The number of patients in which the intubation was successful at the first time.
    Time Frame
    Intraoperative intubation
    Title
    Difficulty of Intubation Measured Using Visual Analogue Scale
    Description
    Difficulty of intubation will be measured using visual analogue scale (0:easiest, 100:most difficult).
    Time Frame
    Intraoperative intubation
    Title
    Number of Participants for Whom External Laryngeal Manipulation Was Necessary
    Description
    External laryngeal manipulation is defined as the compression of neck for the facilitation of laryngeal view. Number of participants for whom external laryngeal manipulation was necessary will be measured.
    Time Frame
    Intraoperative intubation
    Title
    Cormack-Lehan Grade
    Description
    The grade of Cormack-Lehan was assessed as I/II/III/IV (I: Full view of glottis, II: Partial view of glottis, III: Only epiglottis seen, none of glottis seen, IV: Neither glottis nor epiglottis seen). Grade I was considered better outcomes.
    Time Frame
    Intraoperative intubation
    Title
    Mallampati Grade
    Description
    The Mallapati grade was assessed as I/II/III/IV (I: Soft palate, uvula, fauces, pillars visible, II: Soft palate, uvula, fauces visible, III: Soft palate, base of uvula visible, IV: Only hard palate visible). Grade I was considered better outcomes.
    Time Frame
    Intraoperative anesthetic induction
    Title
    Thyromental Distance
    Description
    The thyromental distance was measured.
    Time Frame
    Intraoperative anesthetic induction
    Title
    Postoperative Sore Throat Measured Using Visual Analogue Scale
    Description
    Postoperative sore throat will be measured using visual analogue scale (0:no pain, 100: worst pain imaginable)
    Time Frame
    at 1, 24 hr postoperatively
    Title
    Mean Blood Pressure
    Description
    Mean blood pressure is measured before and 2 min after intubation.
    Time Frame
    Intraoperative intubation
    Title
    Heart Rate
    Description
    Heart rates are measured before and 2 min after intubation.
    Time Frame
    Intraoperative intubation
    Title
    Airway Injury
    Description
    Larynx injury is assessed.
    Time Frame
    Intraoperative intubation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients requiring endotracheal intubation for general anesthesia Exclusion Criteria: Difficult airway Rapid sequence induction Recent sore throat Fragile teeth Contraindication for videolaryngoscope Head and neck surgery

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    29332445
    Citation
    Lee YC, Lee J, Son JD, Lee JY, Kim HC. Stylet angulation of 70 degrees reduces the time to intubation with the GlideScope(R): A prospective randomised trial. J Int Med Res. 2018 Apr;46(4):1428-1438. doi: 10.1177/0300060517741065. Epub 2018 Jan 14.
    Results Reference
    derived

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    Effect of Modified Stylet Angulation on the Intubation With GlideScope®

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