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

I

Inonu University

Status

Completed

Conditions

Intubation
Laryngoscopy

Treatments

Device: Videolaryngoscope size 1 Miller blade

Study type

Interventional

Funder types

Other

Identifiers

NCT05515107
C-Mac 2

Details and patient eligibility

About

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.

Full description

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.

Enrollment

130 patients

Sex

All

Ages

1 to 24 months old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

130 participants in 2 patient groups, including a placebo group

Blade will placed on vallecula
Active Comparator group
Description:
Active Comparator: Children will be intubated by the C-MAC VL size 1 Miller blade will placed on the base of the tongue (vallecula)
Treatment:
Device: Videolaryngoscope size 1 Miller blade
Blade will placed under the epiglottis
Placebo Comparator group
Description:
Placebo Comparator: Children will be intubated by the C-MAC VL size 1 Miller blade will placed under the epiglottis
Treatment:
Device: Videolaryngoscope size 1 Miller blade

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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