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)
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1
Yonsei University Health System, Severance Hospital
Seoul, South Korea