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OpenTrials
Completed

NCT Number: NCT04745936

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

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.

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Key information

Conditions

Intubation

Age range

Up to 1 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Style curve similar to natural curvature of endotracheal tube

Other

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

Other

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

Primary outcomes

  1. Tube handling time

    Time frame: during procedure

    From glottis visualization to completion of tracheal intubation

Secondary outcomes

  1. Total intubation time

    Time frame: during procedure

    From insertion of C-MAC blade to completion of tracheal intubation

  2. Time to reaching glottis

    Time frame: during procedure

    From visualization of glottis to reaching the glottis of tube tip

  3. The location of the initial tube tip

    Time frame: during procedure

    The location of the initial tube tip on the screen of C-MAC

  4. Successful tracheal intubation

    Time frame: during procedure, within 30 sec

    Incidence of successful intubation within 30 sec

  5. Additional manipulation of stylet angle

    Time frame: during procedure

  6. Number of external laryngeal manipulation

    Time frame: during procedure

  7. Easiness of tracheal intubation

    Time frame: during procedure

    Visual analogue scale (0-10, 0: extremely easy, 10: extremely difficult)

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 9, 2021
Registry last updated
Jun 1, 2022

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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