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

NCT05286021 | Completed

• 1 other identifier: 1-2021-0079
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Marrow Examination; Urologic Surgical Procedures; Orthopedic Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Oropharyngeal leak pressure 10 minutes after positioning for surgery

  10 minutes after positioning (either supine or prone position) for surgery.

Study Arms (2)

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

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2022
• First Posted: March 18, 2022
• Study Start: January 5, 2022
• Primary Completion: January 27, 2024
• Study Completion: January 27, 2024
• Last Updated: June 6, 2024

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)