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Clinical Trials/NCT03108391
NCT03108391
Unknown
Not Applicable

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

Chinese Academy of Medical Sciences1 site in 1 country100 target enrollmentJanuary 1, 2017
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ConditionsSupraglottic Airway

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Supraglottic Airway
Sponsor
Chinese Academy of Medical Sciences
Enrollment
100
Locations
1
Primary Endpoint
Oropharyngeal leak pressure
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2017
End Date
October 31, 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Juhui Liu

Plastic Surgery Hospital

Chinese Academy of Medical Sciences

Eligibility Criteria

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

Outcomes

Primary Outcomes

Oropharyngeal leak pressure

Time Frame: 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 Outcomes

  • Insertion time(Up to 1 minute on each insertion attempt)
  • Ease of insertion(Up to 1 minute on each insertion attempt)
  • Fiberoptic Grade of Laryngeal View(Up to 1 minute after placement of device)
  • Postoperative Complications(2 hours after removal of the device)

Study Sites (1)

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