AuraOnce Performance Observation
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|ClinicalTrials.gov Identifier: NCT04128527|
Recruitment Status : Completed
First Posted : October 16, 2019
Last Update Posted : November 19, 2019
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|
|Study Type :||Observational|
|Actual Enrollment :||16 participants|
|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|
- Device: Placement of laryngeal mask
All participants are experienced in placement of laryngeal masks and placement will be performed according to standard clinical practice.
- Leakage [ Time Frame: During procedure ]Is leakage observed (yes/no) if yes, insert signs of leakage
- Ease of insertion [ Time Frame: During procedure ]Investigator evaluation of ease of insertion on a 5-point scale (very difficult to very easy)
- 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)
- Overall performance [ Time Frame: During procedure ]Investigator evaluation of overall performance on a 5-point scale (very bad to excellent)
- Correct placement [ Time Frame: During procedure ]It is checked if the mask is placed above the vocal cords (yes/no)
- Folding of tip [ Time Frame: During procedure ]It is checked if the tip is folding (yes/no)
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
|Copenhagen, Denmark, 2100|