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Comparison of the Clinical Performance and Safety of the Ambu®AuraGainTM Laryngeal Mask in Children Undergoing Surgery in the Supine and Prone Position - A Prospective, Noninferiority Clinical Trial

Sponsor
Yonsei University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05286021
Collaborator
(none)
134
Enrollment
1
Location
9.9
Anticipated Duration (Months)
13.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The Ambu Auragain is a 2nd generation laryngeal mask airway that is widely used in adult and pedicatric patients. While its use is generally recommended in patients undergoing surgery in the supine position, depending on patient characteristics, type of surgery and experience of the anesthesiologist, it may also be used in the lateral or prone position. There have been reports of LMA use in patients undergoing short procedures in the prone position, but its safety in pediatric patients is not clear. This study was designed to compare oropharyngeal leak pressure between children undergoing surgery in the supine and prone position using the Ambu Auragain LMA.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    134 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Comparison of the Clinical Performance and Safety of the Ambu®AuraGainTM Laryngeal Mask in Children Undergoing Surgery in the Supine and Prone Position - A Prospective, Noninferiority Clinical Trial
    Anticipated Study Start Date :
    Mar 1, 2022
    Anticipated Primary Completion Date :
    Dec 27, 2022
    Anticipated Study Completion Date :
    Dec 28, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Supine group

    Children undergoing surgery in the supine position using the Ambu Auragain
    Prone group

    Children undergoing surgery in the prone position using the Ambu Auragain

    Outcome Measures

    Primary Outcome Measures

    1. Oropharyngeal leak pressure immediately after LMA insertion [During procedure (Immediately after AmbuAuragain LMA insertion)]

      Oropharyngeal leak pressure is commonly used as a parameter to assess the clinical performance of supraglottic airway devices (SADs). It is defined as the anesthesia circuit pressure at which a gas leak occurs around the SAD.

    Secondary Outcome Measures

    1. Oropharyngeal leak pressure 10 minutes after positioning for surgery [10 minutes after positioning (either supine or prone position) for surgery.]

      Oropharyngeal leak pressure is commonly used as a parameter to assess the clinical performance of supraglottic airway devices (SADs). It is defined as the anesthesia circuit pressure at which a gas leak occurs around the SAD.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Pediatric patients undergoing surgery within 2 hours under general anesthesia in either the supine or prone position using the Ambu Auragain LMA.

    Patients aged 2-12 years, weight 10-30 kg, ASA class 1~3

    Exclusion Criteria:

    Active URI, symptomatic lung disease (uncontrolled asthma, pneumonia etc), patients with history of difficult airway, anticipated difficult mask ventilation, risk of aspiration such as gastroesophageal reflux

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yonsei University Health System, Severance Hospital Seoul Korea, Republic of

    Sponsors and Collaborators

    • Yonsei University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yonsei University
    ClinicalTrials.gov Identifier:
    NCT05286021
    Other Study ID Numbers:
    • 1-2021-0079
    First Posted:
    Mar 18, 2022
    Last Update Posted:
    Mar 18, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Mar 18, 2022