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

Inönü University Department of Anesthesia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05515107
Enrollment
130
Registered
2022-08-25
Start date
2022-09-01
Completion date
2022-10-10
Last updated
2022-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intubation, Laryngoscopy

Keywords

Infant, glottis, Laryngoscopy, Intubation

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.

Interventions

DEVICEVideolaryngoscope size 1 Miller blade

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

Sponsors

Inonu University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Double (Participant, Outcomes Assessor)

Intervention model description

Randomized Parallel Assignment

Eligibility

Sex/Gender
ALL
Age
1 Months to 24 Months
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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of glottic opening scoreimmediately before endotracheal intubationPercentage 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

MeasureTime frameDescription
Time to intubationFrom beginning of holding videolaryngoscope to seeing two meaningful end-tidal carbon dioxide levels up to 3 minutesTime 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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026