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NCT04745936 Clinical Trial

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

Intubation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04745936
Other study ID # H2011-196-1178
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 3, 2021
Est. completion date May 20, 2022

Study information
Verified date May 2022
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 114
Est. completion date May 20, 2022
Est. primary completion date May 20, 2022
Accepts healthy volunteers No
Gender All
Age group N/A to 1 Year
Eligibility Inclusion Criteria: ? Infants under 1 year old scheduled for elective surgery under general anesthesia ? American Society of Anesthesiology physical status I, II Exclusion Criteria: - Any pulmonary disease

Study Design

Related Conditions & MeSH terms

Intervention

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.
• Style curve similar to hockey stick shape
Stylet curvature is made similar to hockey stick shape for intubation using C-MAC videolaryngoscope.

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

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