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Completed

NCT Number: NCT02952690

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.

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Key information

Conditions

Intubation

Age range

1 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SNUH

Seoul, Jongro Gu, 15710, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glidescope® with tip manipulated stylet

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)

Glidescope® with standard-curved tip

Device

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

Primary outcomes

  1. 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

  1. Time to approaching of endotracheal tube tip to glottis

    Time frame: up to 3 min after insertion of GVL

    From the insertion of GVL to approaching of endotracheal tube tip to glottis

  2. Number of attempt for glottis passage of endotracheal tube

    Time frame: up to 3 min after insertion of GVL

  3. The change in stylet angle

    Time frame: up to 3 min after insertion of GVL

    The number of additional manipulation of stylet for success of endotracheal intubation

  4. Visual analogue scale for the easiness of endotracheal intubation

    Time frame: up to 3 min after insertion of GVL

    Measurement of the easiness of endotracheal intubation

  5. Successful endotracheal intubation in 30 seconds

    Time frame: up to 3 min after insertion of GVL

    Success or failure in completion of endotracheal intubation in 30 seconds

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 2, 2016
Registry last updated
Feb 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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