Different Stylet Angles for Orotracheal Intubation Using Glidescope® Video Laryngoscope in Children

NCT ID: NCT02952690

Last Updated: 2018-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2017-04-30

Brief Summary

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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.

Detailed Description

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Pediatric patients aged 1-5 year old are randomly assigned to one of two groups; standard curve (S) and tip-manipulated curve (T) groups. After routine anesthetic induction, endotracheal intubation is performed with GVL. Size of GVL blade is selected according to weight; GVL 0: \<1.5kg, GVL 1:1.5-3.6kg, GVL 2: 1.8-10kg, GVL 2.5: 10-28kg). Before intubation, stylet curve is differently manipulated according to group. The style is curved in accordance with the curve of GVL blade in S group, whereas the distal tip of style is additionally bended to the left (15-20 degree) in T group.

Time from visualization of glottis with GVL to approaching of endotracheal tube to glottis, and time to completion of intubation are measured. In addition, the easiness of intubation is assessed using Visual Analogue Scale (0: extremely easy, 10: extremely difficult) and will be compared in both groups.

Conditions

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Intubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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standard curve group

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

Group Type ACTIVE_COMPARATOR

Glidescope® with standard-curved tip

Intervention Type DEVICE

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

tip-manipulated curve group

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.

Group Type EXPERIMENTAL

Glidescope® with tip manipulated stylet

Intervention Type DEVICE

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)

Interventions

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Glidescope® with tip manipulated stylet

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)

Intervention Type DEVICE

Glidescope® with standard-curved tip

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. History of asthma
2. Active upper respiratory infection
3. Significant cardiopulmonary disease
Minimum Eligible Age

1 Year

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hee-Soo Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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SNUH

Seoul, Jongro Gu, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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H1608-156-787

Identifier Type: -

Identifier Source: org_study_id

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