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Completed

NCT Number: NCT06484517

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.

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Key information

Conditions

Difficult Intubation

Age range

6 month–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University Pendik Research and Training Hospital

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Mc Grath Videolaryngoscope

Primary outcomes

  1. Success of intubation

    Time frame: Procedure (At the time of the intubation of the patient.)

    Number of attempts of the intubation.

Secondary outcomes

  1. Percentage of glottis opening (POGO)

    Time frame: Procedure (At the time of the intubation of the patient.)

    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.

  2. Need for optimization maneuvers

    Time frame: Procedure (At the time of the intubation of the patient.)

    Whether there are any optimization maneuvers by an assistant.

  3. Degree of hemodynamic changes

    Time frame: Procedure (At the time of the intubation of the patient.)

    Whether there are any acute changes in the patient heart rate during the intubation.

  4. blood pressure

    Time frame: Procedure (At the time of the intubation of the patient.)

    Whether there are any acute changes in the patient blood pressure during the intubation.

  5. Success of intubation

    Time frame: Procedure (At the time of the intubation of the patient.)

    Number of attempts of the intubation.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jul 3, 2024
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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