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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05286021

Enrollment

126

Registered

2022-03-18

Start date

2022-01-05

Completion date

2024-01-27

Last updated

2024-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Marrow Examination, Orthopedic Surgery, Urologic Surgical Procedures

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Years to 12 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

South Korea

Outcome results