Is HugeMed Video Laryngoscope Superior to McGrath in Pediatric Patients

NCT06484517 | Completed

• 1 other identifier: 09.2021.961
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Difficult Intubation

Outcome Measures

Primary Outcomes (1)

• Success of intubation

  Number of attempts of the intubation.

  Procedure (At the time of the intubation of the patient.)

Secondary Outcomes (5)

• Percentage of glottis opening (POGO)

  Procedure (At the time of the intubation of the patient.)

• Need for optimization maneuvers

  Procedure (At the time of the intubation of the patient.)

• Degree of hemodynamic changes

  Procedure (At the time of the intubation of the patient.)

• blood pressure

  Procedure (At the time of the intubation of the patient.)

• Success of intubation

  Procedure (At the time of the intubation of the patient.)

Study Arms (2)

The group of patients (Group M, n=20) was intubated with the McGrath videolaryngoscope.

ACTIVE COMPARATOR

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

For the group (Group H, n=20), the Hugemed videolaryngoscope was used.

EXPERIMENTAL

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

Interventions

Hugemed Videolaryngoscope DEVICE

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.

Also known as: Mc Grath Videolaryngoscope

For the group (Group H, n=20), the Hugemed videolaryngoscope was used.; The group of patients (Group M, n=20) was intubated with the McGrath videolaryngoscope.

Eligibility Criteria

• Age: 6 Months - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University Pendik Research and Training Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• Cabakli GT, Saracoglu KT, Abdullayev R, Guclu E, Ratajczyk P, Saracoglu A. A Comparison of McGrath Mac and HugeMed Video Laryngoscopes in Pediatric Patients Under 3 Years Old-A Prospective Randomized Trial. Healthcare (Basel). 2025 Apr 7;13(7):842. doi: 10.3390/healthcare13070842.

  PMID: 40218139 DERIVED

Study Officials

• Gamze Çabaklı

  Marmara University Department of Anesthesiology and Reanimation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: June 16, 2024
• First Posted: July 3, 2024
• Study Start: March 1, 2022
• Primary Completion: October 1, 2022
• Study Completion: January 31, 2023
• Last Updated: January 20, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)