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Clinical Trials/NCT02952690
NCT02952690CompletedNot Applicable

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

Seoul National University Hospital1 site in 1 country120 target enrollmentStarted: December 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
120
Locations
1
Primary Endpoint
Time to tracheal intubation

Study Overview

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Single (Participant)

Eligibility Criteria

Ages
1 Year to 5 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

standard curve group

Active Comparator

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

Intervention: Glidescope® with standard-curved tip (Device)

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.

Intervention: Glidescope® with tip manipulated stylet (Device)

Outcomes

Primary Outcomes

Time to tracheal intubation

Time Frame: up to 3 min after insertion of GVL

From the insertion of GVL to completion of endotracheal intubation

Secondary Outcomes

  • Time to approaching of endotracheal tube tip to glottis(up to 3 min after insertion of GVL)
  • Successful endotracheal intubation in 30 seconds(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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hee-Soo Kim

Professor

Seoul National University Hospital

Study Sites (1)

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