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AuraOnce Performance Observation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04128527
Recruitment Status : Completed
First Posted : October 16, 2019
Last Update Posted : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
Ambu A/S

Brief Summary:

This study is designed as a single-center, prospective observational, non-controlled, non-interventional study with an investigation period lasting for one day (during one bronchoscopy procedure). The study will take place in Denmark.

The study will include minimum 15 and maximum 20 adult patients planned for a diagnostic flexible bronchoscopy procedure in general anaesthesia using a laryngeal mask. The involved site will include subjects during a one month period, October 2019.

The intention is to perform a quality assessment of the AuraOnce. Subjects will not be asked to participate in this study as it is a quality study where the AuraOnce is used within its intended use and according to normal clinical procedure.


Condition or disease Intervention/treatment
Anesthesia Device: Placement of laryngeal mask

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Study Type : Observational
Actual Enrollment : 16 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Non-interventional Evaluation of Insertion and Sealing Performance of AuraOnce Disposable Laryngeal Mask US Version
Actual Study Start Date : October 9, 2019
Actual Primary Completion Date : November 5, 2019
Actual Study Completion Date : November 5, 2019

Intervention Details:
  • Device: Placement of laryngeal mask
    All participants are experienced in placement of laryngeal masks and placement will be performed according to standard clinical practice.


Primary Outcome Measures :
  1. Leakage [ Time Frame: During procedure ]
    Is leakage observed (yes/no) if yes, insert signs of leakage


Secondary Outcome Measures :
  1. Ease of insertion [ Time Frame: During procedure ]
    Investigator evaluation of ease of insertion on a 5-point scale (very difficult to very easy)

  2. Ease of obtaining seal [ Time Frame: During procedure ]
    Investigator evaluation of ease of obtaining seal on a 5-point scale (very difficult to very easy)

  3. Overall performance [ Time Frame: During procedure ]
    Investigator evaluation of overall performance on a 5-point scale (very bad to excellent)

  4. Correct placement [ Time Frame: During procedure ]
    It is checked if the mask is placed above the vocal cords (yes/no)

  5. Folding of tip [ Time Frame: During procedure ]
    It is checked if the tip is folding (yes/no)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients planned for a diagnostic flexible bronchoscopy procedure in general anaesthesia using a laryngeal mask.
Criteria

Inclusion Criteria:

  • Subjects > 18 years
  • Subjects planned for diagnostic flexible bronchoscopy procedure in general anesthesia using a laryngeal mask.

Exclusion Criteria:

- Subjects where use of AuraOnce cannot be clinically justified


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): NCT04128527


Locations
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Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Ambu A/S

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Responsible Party: Ambu A/S
ClinicalTrials.gov Identifier: NCT04128527    
Other Study ID Numbers: CIS-016
First Posted: October 16, 2019    Key Record Dates
Last Update Posted: November 19, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No