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

June 7, 2017 updated by: Hyun-Chang Kim, Keimyung University Dongsan Medical Center

Stylet Angulation of Seventy Degrees Reduced Time to Intubation With the GlideScope®: A Prospective Randomized Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

162

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 90 degree
The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end.
Procedure: Glidescope guided intubation
Device: GlideScope®
Experimental: 70 degree
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.
Procedure: Glidescope guided intubation
Device: GlideScope®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Intubation
Time Frame: Intraoperative intubation
Time from the insertion of the Glidescope blade to the measurement of end tidal CO2 (>30 mmHg)
Intraoperative intubation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success Rate of Intubation
Time Frame: Intraoperative intubation
The number of patients in which the intubation was successful at the first time.
Intraoperative intubation
Difficulty of Intubation Measured Using Visual Analogue Scale
Time Frame: Intraoperative intubation
Difficulty of intubation will be measured using visual analogue scale (0:easiest, 100:most difficult).
Intraoperative intubation
Number of Participants for Whom External Laryngeal Manipulation Was Necessary
Time Frame: Intraoperative intubation
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.
Intraoperative intubation
Cormack-Lehan Grade
Time Frame: Intraoperative intubation
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.
Intraoperative intubation
Mallampati Grade
Time Frame: Intraoperative anesthetic induction
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.
Intraoperative anesthetic induction
Thyromental Distance
Time Frame: Intraoperative anesthetic induction
The thyromental distance was measured.
Intraoperative anesthetic induction
Postoperative Sore Throat Measured Using Visual Analogue Scale
Time Frame: at 1, 24 hr postoperatively
Postoperative sore throat will be measured using visual analogue scale (0:no pain, 100: worst pain imaginable)
at 1, 24 hr postoperatively
Mean Blood Pressure
Time Frame: Intraoperative intubation
Mean blood pressure is measured before and 2 min after intubation.
Intraoperative intubation
Heart Rate
Time Frame: Intraoperative intubation
Heart rates are measured before and 2 min after intubation.
Intraoperative intubation
Airway Injury
Time Frame: Intraoperative intubation
Larynx injury is assessed.
Intraoperative intubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Keimyung University Dongsan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

September 1, 2015

First Submitted That Met QC Criteria

September 9, 2015

First Posted (Estimate)

September 11, 2015

Study Record Updates

Last Update Posted (Actual)

June 9, 2017

Last Update Submitted That Met QC Criteria

June 7, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GlideMStylet

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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