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

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

Study Overview

• Status: Unknown
• Conditions: Supraglottic Airway
• Intervention / Treatment: Device: Ambu AuraGain; Device: LMA Supreme

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100144
      • Recruiting
      • ChineseAMS
      • Contact: Liu Juhui, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ambu AuraGain; Subjects will receive the Ambu AuraGain size 3 to size 5 based on manufacturer guidelines	Device: Ambu AuraGain
Active Comparator: LMA Supreme; Subjects will receive the LMA Supreme size 3 to size 5 based on manufacturer guidelines	Device: LMA Supreme

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oropharyngeal leak pressure	The airway pressure at which an airway leak is observed after successful placement of the device	Up to 1 minute after the time of confirmed device placement

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Investigators: Principal Investigator: Liu Juhui, MD, Plastic Surgery Hospital, ChineseAMS

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Anticipated): October 31, 2017
• Study Completion (Anticipated): October 31, 2017

Study Registration Dates

• First Submitted: March 14, 2017
• First Submitted That Met QC Criteria: April 5, 2017
• First Posted (Actual): April 11, 2017

Study Record Updates

• Last Update Posted (Actual): April 12, 2017
• Last Update Submitted That Met QC Criteria: April 11, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: PSH-2016-8

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided