The Laryngoscopic View With C-MAC Videolaryngoscope Miller Blade Lifting the Epiglottis or the Vallecula in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2022-10-10

Brief Summary

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In this study, the investigators aim to evaluate the glottic visualization and time to intubation during laryngoscopy performed with the C-MAC VL size 1 Miller blade lifting the epiglottis or placing the tip of the blade on the base of the tongue (vallecula) in children younger than 2 years of age.

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Detailed Description

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Direct laryngoscopy (DL) is the most widely used method to ensure airway safety. In pediatric patients under two years of age, Miller laryngoscope blade is recommended as it removes the long and drooping epiglottis from the eye during laryngoscopy and shows the laryngeal entrance better.

In the classical definition, the tip of the Miller blade is placed behind the epiglottis. However, if the intubator wishes, the Miller blade tip can be placed on the root of the tongue (vallecula) and used as a Macintosh blade.

In the literature search, no study has been found so far comparing C-MAC VL 1 numbered Miller blade with intubation by removing the epiglottis or placing the blade on the vallecula. In this study, the investigators aimed to evaluate the glottic image and intubation time during laryngoscopy performed by lifting the epiglottis with the C-MAC VL No. 1 Miller blade or placing the tip of the blade on the base of the tongue in children under 2 years of age.

Conditions

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Intubation Laryngoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Parallel Assignment

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Double (Participant, Outcomes Assessor)

Study Groups

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Blade will placed on vallecula

Active Comparator: Children will be intubated by the C-MAC VL size 1 Miller blade will placed on the base of the tongue (vallecula)

Group Type ACTIVE_COMPARATOR

Videolaryngoscope size 1 Miller blade

Intervention Type DEVICE

An intubating device that is used for endotracheal intubation. Endotracheal intubation will be performed by anesthesiologist with C-MAC videolaryngoscope

Blade will placed under the epiglottis

Placebo Comparator: Children will be intubated by the C-MAC VL size 1 Miller blade will placed under the epiglottis

Group Type PLACEBO_COMPARATOR

Videolaryngoscope size 1 Miller blade

Intervention Type DEVICE

An intubating device that is used for endotracheal intubation. Endotracheal intubation will be performed by anesthesiologist with C-MAC videolaryngoscope

Interventions

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Videolaryngoscope size 1 Miller blade

An intubating device that is used for endotracheal intubation. Endotracheal intubation will be performed by anesthesiologist with C-MAC videolaryngoscope

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Younger than 2 years of age
* ASA I and II patients
* Elective surgery under general anesthesia with tracheal intubation

Exclusion Criteria

* upper respiratory tract infection within the previous 4 weeks
* airway difficulties in the preoperative evaluation
* unstable reactions during intubation

Minimum Eligible Age

1 Month

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes