NCT02547064

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2015

Shorter than P25 for not_applicable

Status
completed

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

September 1, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 11, 2015

Completed
20 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

June 9, 2017

Completed
Last Updated

June 9, 2017

Status Verified

June 1, 2017

Enrollment Period

3 months

First QC Date

September 1, 2015

Results QC Date

June 28, 2016

Last Update Submit

June 7, 2017

Conditions

Keywords

intubationstyletvideolaryngoscope

Outcome Measures

Primary Outcomes (1)

  • Time to Intubation

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

    Intraoperative intubation

Secondary Outcomes (10)

  • Success Rate of Intubation

    Intraoperative intubation

  • Difficulty of Intubation Measured Using Visual Analogue Scale

    Intraoperative intubation

  • Number of Participants for Whom External Laryngeal Manipulation Was Necessary

    Intraoperative intubation

  • Cormack-Lehan Grade

    Intraoperative intubation

  • Mallampati Grade

    Intraoperative anesthetic induction

  • +5 more secondary outcomes

Study Arms (2)

90 degree

ACTIVE COMPARATOR

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

Procedure: Glidescope guided intubationDevice: GlideScope®

70 degree

EXPERIMENTAL

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 intubationDevice: GlideScope®

Interventions

70 degree90 degree
70 degree90 degree

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients requiring endotracheal intubation for general anesthesia

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

CholecystitisStomach Neoplasms

Condition Hierarchy (Ancestors)

Gallbladder DiseasesBiliary Tract DiseasesDigestive System DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsGastrointestinal DiseasesStomach Diseases

Results Point of Contact

Title
Hyun-Chang Kim
Organization
Keimyung university

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

September 1, 2015

First Posted

September 11, 2015

Study Start

October 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

June 9, 2017

Results First Posted

June 9, 2017

Record last verified: 2017-06