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

Intubation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02952690
• Other study ID #: H1608-156-787
• Status: Completed
• Phase: N/A
• First received: October 19, 2016
• Last updated: February 16, 2018
• Start date: December 2016
• Est. completion date: April 2017

Study information

• Verified date: February 2018
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Intubation

Intervention

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)
• Glidescope® with standard-curved tip
The style is curved in accordance with the curve of GVL blade

Locations

Country	Name	City	State
Korea, Republic of	SNUH	Seoul	Jongro Gu

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to tracheal intubation	From the insertion of GVL to completion of endotracheal intubation	up to 3 min after insertion of GVL
Secondary	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
Secondary	Number of attempt for glottis passage of endotracheal tube		up to 3 min after insertion of GVL
Secondary	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
Secondary	Visual analogue scale for the easiness of endotracheal intubation	Measurement of the easiness of endotracheal intubation	up to 3 min after insertion of GVL
Secondary	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