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

Sponsor

Inonu University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05515107

Collaborator

(none)

130

Enrollment

Location

Arms

1.4

Anticipated Duration (Months)

94.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intubation Laryngoscopy	Device: Videolaryngoscope size 1 Miller blade	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

130 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized Parallel AssignmentRandomized Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Inönü University Department of Anesthesia

Anticipated Study Start Date :

Aug 29, 2022

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Oct 10, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 24 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Inonu University	Malatya		Turkey	44280

Sponsors and Collaborators

Inonu University

Investigators

Study Chair: Zekine Begec, Professor, Inonu University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zekine Begec, Professor, Inonu University

ClinicalTrials.gov Identifier:

NCT05515107

Other Study ID Numbers:

C-Mac 2

First Posted:

Aug 25, 2022

Last Update Posted:

Aug 25, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Zekine Begec, Professor, Inonu University

Study Results

No Results Posted as of Aug 25, 2022