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AuraOnce Performance Observation

NCT04128527 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 16

Last updated 2021-11-03

Study results available
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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.

Conditions

  • Anesthesia

Interventions

DEVICE

Placement of laryngeal mask

All participants are experienced in placement of laryngeal masks and placement will be performed according to standard clinical practice.

Sponsors & Collaborators

  • Ambu A/S

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-09
Primary Completion
2019-11-05
Completion
2019-11-05
FDA Device
Yes

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04128527 on ClinicalTrials.gov