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

• Conditions: Bone Marrow Examination; Urologic Surgical Procedures; Orthopedic Surgery

• Registration Number: NCT05286021
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-05
• Status Verified: 2022-03
• Study First Submitted: 2022-03-06
• Study First Submitted QC: 2022-03-16
• Study First Posted: 2022-03-18
• Primary Completion: 2024-01-27
• Study Completion: 2024-01-27
• Last Update Submitted: 2024-06-05
• Last Update Posted: 2024-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Yonsei University Health System, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of