A Comparison of the Ambu®AuraGain™ and the Laryngeal Mask Airway Supreme™ in Normal Airway Patients

Not Applicable

• Conditions: Supraglottic Airway
• Interventions: Device: Ambu AuraGain; Device: LMA Supreme

• Registration Number: NCT03108391
• Lead Sponsor: Chinese Academy of Medical Sciences

Brief Summary

The study is designed to compare the performance of the Ambu AuraGain Laryngeal Mask Airway and LMA Supreme in normal airway patients.

Detailed Description

Ambu AuraGain Laryngeal Mask Airway is a newly designed supraglottic device. We design this study to test its clinical performance in normal airway patients, in comparison with LMA Supreme.

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2017-03-14
• Status Verified: 2017-04
• Study First Submitted QC: 2017-04-05
• Study First Posted: 2017-04-11
• Last Update Submitted: 2017-04-11
• Last Update Posted: 2017-04-12
• Primary Completion: 2017-10-31
• Study Completion: 2017-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• American Society of Anesthesiologists Ⅰ-Ⅲ classification
• Patients evaluated as eligible for a LMA
• Body Mass Index ≤35kg/m2

Exclusion Criteria

• Patients with known or predicted difficult airway
• Active respiratory infection
• Risk of aspiration
• Head and neck surgery
• Emergent surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ambu AuraGain	Ambu AuraGain	Subjects will receive the Ambu AuraGain size 3 to size 5 based on manufacturer guidelines
LMA Supreme	LMA Supreme	Subjects will receive the LMA Supreme size 3 to size 5 based on manufacturer guidelines

Primary Outcome Measures

Name	Time	Method
Oropharyngeal leak pressure	Up to 1 minute after the time of confirmed device placement	The airway pressure at which an airway leak is observed after successful placement of the device

Secondary Outcome Measures

Name	Time	Method
Insertion time	Up to 1 minute on each insertion attempt	Time needed to insert the device
Ease of insertion	Up to 1 minute on each insertion attempt	Number of attempts to place the device
Fiberoptic Grade of Laryngeal View	Up to 1 minute after placement of device	Fiberoptic Grade of Laryngeal View through each device will be graded using a previously grading system
Postoperative Complications	2 hours after removal of the device	Patient will be evaluated for sore throat, dysphonia, stridor, dysphagia, blood stain on device

Trial Locations

Locations (1)

ChineseAMS; 🇨🇳 Beijing, Beijing, China