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

Not Applicable

Completed

• Conditions: Intubation
• Interventions: Device: Glidescope® with standard-curved tip; Device: Glidescope® with tip manipulated stylet

• Registration Number: NCT02952690
• Lead Sponsor: Seoul National University Hospital

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 Timeline

• Study First Submitted: 2016-10-19
• Study First Submitted QC: 2016-10-31
• Study First Posted: 2016-11-02
• Study Start: 2016-12
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-16
• Last Update Posted: 2018-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard curve group	Glidescope® with standard-curved tip	The style is curved in accordance with the curve of GVL blade in this group.
tip-manipulated curve group	Glidescope® with tip manipulated stylet	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.

Primary Outcome Measures

Name	Time	Method
Time to tracheal intubation	up to 3 min after insertion of GVL	From the insertion of GVL to completion of endotracheal intubation

Secondary Outcome Measures

Name	Time	Method
Time to approaching of endotracheal tube tip to glottis	up to 3 min after insertion of GVL	From the insertion of GVL to approaching of endotracheal tube tip to glottis
Successful endotracheal intubation in 30 seconds	up to 3 min after insertion of GVL	Success or failure in completion of endotracheal intubation in 30 seconds
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	The number of additional manipulation of stylet for success of endotracheal intubation
Visual analogue scale for the easiness of endotracheal intubation	up to 3 min after insertion of GVL	Measurement of the easiness of endotracheal intubation

Trial Locations

Locations (1)

SNUH; 🇰🇷 Seoul, Jongro Gu, Korea, Republic of