NCT02952690

Brief Summary

The purpose of this study is to evaluate the feasibility of endotracheal intubation via glidescope videolaryngoscope (GVL) using different curve of stylet in 120 children aged between 1 and 5 year old.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 2, 2016

Completed
29 days until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

February 19, 2018

Status Verified

February 1, 2018

Enrollment Period

4 months

First QC Date

October 19, 2016

Last Update Submit

February 16, 2018

Conditions

Intubation

Outcome Measures

Primary Outcomes (1)

  • Time to tracheal intubation

    From the insertion of GVL to completion of endotracheal intubation

    up to 3 min after insertion of GVL

Secondary Outcomes (5)

  • Time to approaching of endotracheal tube tip to glottis

    up to 3 min after insertion of GVL

  • Number of attempt for glottis passage of endotracheal tube

    up to 3 min after insertion of GVL

  • The change in stylet angle

    up to 3 min after insertion of GVL

  • Visual analogue scale for the easiness of endotracheal intubation

    up to 3 min after insertion of GVL

  • Successful endotracheal intubation in 30 seconds

    up to 3 min after insertion of GVL

Study Arms (2)

standard curve group

ACTIVE COMPARATOR

The style is curved in accordance with the curve of GVL blade in this group.

Device: Glidescope® with standard-curved tip

tip-manipulated curve group

EXPERIMENTAL

The style is curved in accordance with the curve of GVL blade and the distal tip of style is additionally bended to the left (15-20 degree) in this group.

Device: Glidescope® with tip manipulated stylet

Interventions

Glidescope® with tip manipulated styletDEVICE

The intubating style is curved in accordance with the curve of GVL blade and the distal tip of style is additionally bended to the left (15-20 degree)

tip-manipulated curve group
Glidescope® with standard-curved tipDEVICE

The style is curved in accordance with the curve of GVL blade

standard curve group

Eligibility Criteria

Age1 Year - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • children aged between 1 and 5 years who are scheduled for elective surgery
  • American Society of Anesthesiologist physical status I, II

You may not qualify if:

  • History of asthma
  • Active upper respiratory infection
  • Significant cardiopulmonary disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SNUH

Seoul, Jongro Gu, 15710, South Korea

Location

Study Design

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

Study Record Dates

First Submitted

October 19, 2016

First Posted

November 2, 2016

Study Start

December 1, 2016

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

February 19, 2018

Record last verified: 2018-02

Locations

KR(1)