Comparison of Different Stylet Angles for Orotracheal Intubation Using C-MAC® Video Laryngoscopes in Infants

May 30, 2022 updated by: Ji-Hyun Lee, Seoul National University Hospital
The purpose of this study is to investigate whether the difference in stylet curvature affects the ease of tracheal intubation using C-MAC videolaryngoscope in infants under 1 year of age.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

① Infants under 1 year old scheduled for elective surgery under general anesthesia

② American Society of Anesthesiology physical status I, II

Exclusion Criteria:

  • Any pulmonary disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: C-curve group (group C)
In group C, stylet curvature is made similar to the natural curvature of endotracheal tube.
Other: Style curve similar to natural curvature of endotracheal tube
Stylet curvature is made similar to the natural curvature of endotracheal tube for intubation using C-MAC videolaryngoscope.
Active Comparator: Hockey stick curve group (group H)
In group H, stylet curvature is made similar to hockey stick shape.
Other: Style curve similar to hockey stick shape
Stylet curvature is made similar to hockey stick shape for intubation using C-MAC videolaryngoscope.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tube handling time
Time Frame: during procedure
From glottis visualization to completion of tracheal intubation
during procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total intubation time
Time Frame: during procedure
From insertion of C-MAC blade to completion of tracheal intubation
during procedure
Time to reaching glottis
Time Frame: during procedure
From visualization of glottis to reaching the glottis of tube tip
during procedure
The location of the initial tube tip
Time Frame: during procedure
The location of the initial tube tip on the screen of C-MAC
during procedure
Successful tracheal intubation
Time Frame: during procedure, within 30 sec
Incidence of successful intubation within 30 sec
during procedure, within 30 sec
Additional manipulation of stylet angle
Time Frame: during procedure
during procedure
Number of external laryngeal manipulation
Time Frame: during procedure
during procedure
Easiness of tracheal intubation
Time Frame: during procedure
Visual analogue scale (0-10, 0: extremely easy, 10: extremely difficult)
during procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2021

Primary Completion (Actual)

May 20, 2022

Study Completion (Actual)

May 20, 2022

Study Registration Dates

First Submitted

February 4, 2021

First Submitted That Met QC Criteria

February 4, 2021

First Posted (Actual)

February 9, 2021

Study Record Updates

Last Update Posted (Actual)

June 1, 2022

Last Update Submitted That Met QC Criteria

May 30, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • H2011-196-1178

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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