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NCT05286021

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

Completed Last updated 6 June 2024
What this trial tests

trial in Bone Marrow Examination in 126 participants. Completed in 27 January 2024.

Timeline
5 January 2022
Primary endpoint
27 January 2024
27 January 2024

Quick facts

Lead sponsorYonsei University
StatusCompleted
Study typeOBSERVATIONAL
Enrollment126
Start date5 January 2022
Primary completion27 January 2024
Estimated completion27 January 2024
Sites1 location across South Korea

Conditions studied

Sponsor

Yonsei University

Who can join

Adults 2 to 12, any sex, with Bone Marrow Examination or Urologic Surgical Procedures. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other Yonsei University trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05286021.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing