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

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ClinicalTrials.gov Identifier: NCT03108391
Recruitment Status : Recruiting
First Posted : April 11, 2017
Last Update Posted : April 12, 2017
Sponsor:
Information provided by (Responsible Party):
Juhui Liu, 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.

Condition or disease Intervention/treatment Phase
Supraglottic Airway Device: Ambu AuraGain Device: LMA Supreme Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parellel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparison of the Ambu®AuraGain™ and the Laryngeal Mask Airway Supreme™ in Normal Airway Patients
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : October 31, 2017
Estimated Study Completion Date : October 31, 2017

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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Insertion time [ Time Frame: Up to 1 minute on each insertion attempt ]
    Time needed to insert the device

  2. Ease of insertion [ Time Frame: Up to 1 minute on each insertion attempt ]
    Number of attempts to place the device

  3. Fiberoptic Grade of Laryngeal View [ Time Frame: Up to 1 minute after placement of device ]
    Fiberoptic Grade of Laryngeal View through each device will be graded using a previously grading system

  4. Postoperative Complications [ Time Frame: 2 hours after removal of the device ]
    Patient will be evaluated for sore throat, dysphonia, stridor, dysphagia, blood stain on device



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03108391


Contacts
Contact: Liu Juhui, MD +8615210258001 liujuhui2006@126.com

Locations
China, Beijing
ChineseAMS Recruiting
Beijing, Beijing, China, 100144
Contact: Liu Juhui, MD         
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
Principal Investigator: Liu Juhui, MD Plastic Surgery Hospital, ChineseAMS

Responsible Party: Juhui Liu, Plastic Surgery Hospital, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT03108391     History of Changes
Other Study ID Numbers: PSH-2016-8
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Chlorhexidine
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants