N/A
Completed N=16
AuraOnce Performance Observation
Source: ClinicalTrials.gov NCT04128527 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcomePrimary: Number of Participants With Leakage Observed During Procedure — 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Leakage Observed During Procedure |
— | — |
| SECONDARY Investigator Evaluation of Ease of Insertion on a 5-point Scale (Very Difficult (=1) to Very Easy (=5)) |
4.6 | — |
| SECONDARY Investigator Evaluation of Ease of Obtaining Seal on a 5-point Scale (Very Difficult (=1) to Very Easy (=5)) |
4.7 | — |
| SECONDARY Investigator Evaluation of Overall Performance on a 5-point Scale (Very Bad (=1) to Excellent (=5)) |
4.6 | — |
| SECONDARY Number of Participants With Correct Placement of Mask |
16 | — |
| SECONDARY Number of Participants Where Tip of the Mask is Folded |
— | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT04128527). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.