Is HugeMed Video Laryngoscope Superior to McGrath in Pediatric Patients

Videolaryngoscopes improve laryngeal visualization in children under 3 years. In this study we aimed to compare Hugemed and McGrath videolaryngoscopes regarding their Cormach-Lehane (CL) and percentage of glottic opening (POGO) scores. Furthermore, tracheal intubation success rates, need for cricoid pressure and optimization maneuvers, and hemodynamic changes are compared.

Study Overview

• Status: Completed
• Conditions: Difficult Intubation
• Intervention / Treatment: Device: Hugemed Videolaryngoscope

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Marmara University Pendik Research and Training Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Study Population

We included a total of 40 elective surgical patients under the age of 3, classified as ASA 1-3 risk group, who underwent general anesthesia with no anticipated difficult airway.

Description

Inclusion Criteria:

total of 40 elective surgical patients under the age of 3, classified as ASA 1-3 risk group, who underwent general anesthesia with no anticipated difficult airway.

Exclusion Criteria:

Patients who could not obtain parental consent, those classified as ASA 4 and above, individuals with serious cardiac and respiratory problems, and patients anticipated to have a difficult airway were not included in the study.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: The group of patients (Group M, n=20) was intubated with the McGrath videolaryngoscope.; Before intubation, Cormack-Lehane score and percentage of glottis opening (POGO) score were recorded by applying direct and indirect laryngoscopy with the Macgreth videolaryngoscope. All tracheal intubations were performed by the same expert with over 10 years of experience in pediatric anesthesia.	Device: Hugemed Videolaryngoscope; After general anesthesia induction, the first group of patients (Group M, n=20) was intubated with the McGrath videolaryngoscope. For the second group (Group H, n=20), the Hugemed videolaryngoscope was used. Patients were intubated using one of the appropriate blades numbered 1, 2, or 3 based on their height, weight, and age.; Other Names: Mc Grath Videolaryngoscope
Experimental: For the group (Group H, n=20), the Hugemed videolaryngoscope was used.; Patients were intubated using one of the appropriate blades numbered 1, 2, or 3 based on their height, weight, and age. After the induction of general anesthesia, patients underwent direct and indirect laryngoscopy with videolaryngoscopes. The Modified Cormack-Lehane score and Percentage of Glottic Opening (POGO) score were recorded, and orotracheal intubation was performed. Number of attempts, need for cricoid pressure, optimization maneuvers, success rate, and hemodynamic parameters of both groups were recorded.	Device: Hugemed Videolaryngoscope; After general anesthesia induction, the first group of patients (Group M, n=20) was intubated with the McGrath videolaryngoscope. For the second group (Group H, n=20), the Hugemed videolaryngoscope was used. Patients were intubated using one of the appropriate blades numbered 1, 2, or 3 based on their height, weight, and age.; Other Names: Mc Grath Videolaryngoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success of intubation	Number of attempts of the intubation.	Procedure (At the time of the intubation of the patient.)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of glottis opening (POGO)	The primary aim of this study was to compare the percentage of glottis opening (POGO, 0-100%) scores in direct and indirect laryngoscopy performed with HugeMed and McGrath video laryngoscopes in pediatric patients.	Procedure (At the time of the intubation of the patient.)
Success of intubation	Number of attempts of the intubation.	Procedure (At the time of the intubation of the patient.)
Need for optimization maneuvers	Whether there are any optimization maneuvers by an assistant.	Procedure (At the time of the intubation of the patient.)
Degree of hemodynamic changes	Whether there are any acute changes in the patient heart rate during the intubation.	Procedure (At the time of the intubation of the patient.)
blood pressure	Whether there are any acute changes in the patient blood pressure during the intubation.	Procedure (At the time of the intubation of the patient.)

Collaborators and Investigators

• Sponsor: Marmara University
• Investigators: Principal Investigator: Gamze Çabaklı, Marmara University Department of Anesthesiology and Reanimation

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): October 1, 2022
• Study Completion (Actual): January 31, 2023

Study Registration Dates

• First Submitted: June 16, 2024
• First Submitted That Met QC Criteria: July 1, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 17, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 09.2021.961

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
• product manufactured in and exported from the U.S.: No