Status:

COMPLETED

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

Lead Sponsor:

Yonsei University

Conditions:

Bone Marrow Examination

Urologic Surgical Procedures

Eligibility:

All Genders

2-12 years

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 po...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 5 2022

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

January 27 2024

Estimated Enrollment :

126 Patients enrolled

Trial Details

Trial ID

NCT05286021

Start Date

January 5 2022

End Date

January 27 2024

Last Update

June 6 2024

Active Locations (1)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

Yonsei University Health System, Severance Hospital

Seoul, South Korea

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 | DecenTrialz