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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 126

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Yonsei University Health System, Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 12 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study will be done in pediatric patients between the ages 2 and 12 years, weight 10 and 30 kg, that are eligible to use the Ambu Auragain LMA for surgical procedures within 2 hours. The patients will undergo surgery in either the supine or prone position.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oropharyngeal leak pressure immediately after 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.	During procedure (Immediately after AmbuAuragain LMA insertion)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oropharyngeal leak pressure 10 minutes after positioning 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.	10 minutes after positioning (either supine or prone position) for surgery.

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2022
• Primary Completion (Actual): January 27, 2024
• Study Completion (Actual): January 27, 2024

Study Registration Dates

• First Submitted: March 6, 2022
• First Submitted That Met QC Criteria: March 16, 2022
• First Posted (Actual): March 18, 2022

Study Record Updates

• Last Update Posted (Actual): June 6, 2024
• Last Update Submitted That Met QC Criteria: June 5, 2024
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 1-2021-0079

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No