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

Intubation Clinical Trial

Official title:

Inönü University Department of Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05515107
• Other study ID #: C-Mac 2
• Status: Completed
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: October 10, 2022

Study information

• Verified date: October 2022
• Source: Inonu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: October 10, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month to 24 Months

Eligibility

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

Related Conditions & MeSH terms

• Intubation
• Laryngoscopy

Intervention

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

Locations

Country	Name	City	State
Turkey	Inonu University	Malatya

Sponsors (1)

Lead Sponsor	Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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