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
About this trial
This is an interventional treatment trial for Cholecystitis focused on measuring intubation, stylet, videolaryngoscope
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
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
NCT ID
NCT02547064
First Posted
September 1, 2015
Last Updated
June 7, 2017
Sponsor
Keimyung University Dongsan Medical Center
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
Learn more about this trial
Effect of Modified Stylet Angulation on the Intubation With GlideScope®
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