AuraOnce Performance Observation

NCT04128527 | Completed Results FDA Device

• 1 other identifier: CIS-016
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Leakage Observed During Procedure

  Is leakage observed (yes/no) if yes, insert signs of leakage

  During procedure, less than 1 hour

Secondary Outcomes (5)

• Investigator Evaluation of Ease of Insertion on a 5-point Scale (Very Difficult (=1) to Very Easy (=5))

  During procedure, less than 1 hour

• Investigator Evaluation of Ease of Obtaining Seal on a 5-point Scale (Very Difficult (=1) to Very Easy (=5))

  During procedure, less than 1 hour

• Investigator Evaluation of Overall Performance on a 5-point Scale (Very Bad (=1) to Excellent (=5))

  During procedure, less than 1 hour

• Number of Participants With Correct Placement of Mask

  During procedure, less than 1 hour

• Number of Participants Where Tip of the Mask is Folded

  During procedure, less than one hour

Interventions

Placement of laryngeal mask DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients planned for a diagnostic flexible bronchoscopy procedure in general anaesthesia using a laryngeal mask.

You may qualify if:

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

You may not qualify if:

• \- Subjects where use of AuraOnce cannot be clinically justified

Sponsors & Collaborators

• Ambu A/S: lead

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Results Point of Contact

• Title: Signe Toräng
• Organization: Ambu

sito@ambu.com

31267089

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2019
• First Posted: October 16, 2019
• Study Start: October 9, 2019
• Primary Completion: November 5, 2019
• Study Completion: November 5, 2019
• Last Updated: November 3, 2021
• Results First Posted: November 3, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)