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

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

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.

Study Overview

• Status: Completed
• Conditions: Intubation
• Intervention / Treatment: Device: Glidescope® with standard-curved tip; Device: Glidescope® with tip manipulated stylet

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jongro Gu
    • Seoul, Jongro Gu, Korea, Republic of, 15710
      • SNUH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 5 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: standard curve group; The style is curved in accordance with the curve of GVL blade in this group.	Device: Glidescope® with standard-curved tip; The style is curved in accordance with the curve of GVL blade
Experimental: 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.	Device: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to tracheal intubation	From the insertion of GVL to completion of endotracheal intubation	up to 3 min after insertion of GVL

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: October 19, 2016
• First Submitted That Met QC Criteria: October 31, 2016
• First Posted (Estimate): November 2, 2016

Study Record Updates

• Last Update Posted (Actual): February 19, 2018
• Last Update Submitted That Met QC Criteria: February 16, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: H1608-156-787

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED