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

Inönü University Department of Anesthesia

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.

Study Overview

• Status: Completed
• Conditions: Intubation; Laryngoscopy
• Intervention / Treatment: Device: Videolaryngoscope size 1 Miller blade

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 Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Malatya, Turkey, 44280
    • Inonu University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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)	Device: 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
Placebo Comparator: 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	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of glottic opening score	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%	immediately before endotracheal intubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to intubation	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	From beginning of holding videolaryngoscope to seeing two meaningful end-tidal carbon dioxide levels up to 3 minutes

Collaborators and Investigators

• Sponsor: Inonu University
• Investigators: Study Chair: Zekine Begec, Professor, Inonu University

Publications and helpful links

General Publications

• Varghese E, Kundu R. Does the Miller blade truly provide a better laryngoscopic view and intubating conditions than the Macintosh blade in small children? Paediatr Anaesth. 2014 Aug;24(8):825-9. doi: 10.1111/pan.12394. Epub 2014 Apr 2.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): October 10, 2022

Study Registration Dates

• First Submitted: August 23, 2022
• First Submitted That Met QC Criteria: August 24, 2022
• First Posted (Actual): August 25, 2022

Study Record Updates

• Last Update Posted (Actual): October 12, 2022
• Last Update Submitted That Met QC Criteria: October 10, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Infant; Intubation; Laryngoscopy; glottis
• Other Study ID Numbers: C-Mac 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No