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

Not Applicable

Completed

• Conditions: Intubation; Laryngoscopy
• Interventions: Device: Videolaryngoscope size 1 Miller blade

• Registration Number: NCT05515107
• Lead Sponsor: Inonu University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-08-23
• Study First Submitted QC: 2022-08-24
• Study First Posted: 2022-08-25
• Study Start: 2022-09-01
• Primary Completion: 2022-09-30
• Status Verified: 2022-10
• Study Completion: 2022-10-10
• Last Update Submitted: 2022-10-10
• Last Update Posted: 2022-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Percentage of glottic opening score	immediately before endotracheal intubation	Percentage of glottic opening score of 100% denotes visualization of the entire glottis, from the anterior commissure of the vocal cords to the inter-arytenoid notch. If no part of the glottic opening was visualized, the POGO score was recorded as 0%

Secondary Outcome Measures

Name	Time	Method
Time to intubation	From beginning of holding videolaryngoscope to seeing two meaningful end-tidal carbon dioxide levels up to 3 minutes	Time to intubation will be measured from the time the videolaryngoscope entered the patient's mouth until the first capnograph trace is seen on the monitor

Trial Locations

Locations (1)

Inonu University; 🇹🇷 Malatya, Turkey