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

NCT05515107 | Completed

• 1 other identifier: C-Mac 2
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Intubation; Laryngoscopy

Keywords

Infant; glottis; Laryngoscopy; Intubation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Time to intubation

  From beginning of holding videolaryngoscope to seeing two meaningful end-tidal carbon dioxide levels up to 3 minutes

Study Arms (2)

Blade will placed on vallecula

ACTIVE COMPARATOR

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

Blade will placed under the epiglottis

PLACEBO COMPARATOR

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

Interventions

Videolaryngoscope size 1 Miller blade DEVICE

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

Blade will placed on vallecula; Blade will placed under the epiglottis

Eligibility Criteria

• Age: 1 Month - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Inonu University

Malatya, 44280, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 24690084 RESULT

Study Officials

• Zekine Begec, Professor

  Inonu University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double (Participant, Outcomes Assessor)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized Parallel Assignment

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: August 25, 2022
• Study Start: September 1, 2022
• Primary Completion: September 30, 2022
• Study Completion: October 10, 2022
• Last Updated: October 12, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)