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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04128527
Other study ID # CIS-016
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 9, 2019
Est. completion date November 5, 2019

Study information

Verified date August 2021
Source Ambu A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date November 5, 2019
Est. primary completion date November 5, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Denmark Rigshospitalet Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
Ambu A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Investigator Evaluation of Ease of Insertion on a 5-point Scale (Very Difficult (=1) to Very Easy (=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
Secondary Investigator Evaluation of Ease of Obtaining Seal on a 5-point Scale (Very Difficult (=1) to Very Easy (=5)) 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
Secondary Investigator Evaluation of Overall Performance on a 5-point Scale (Very Bad (=1) to Excellent (=5)) Investigator evaluation of overall performance on a 5-point scale (very bad (=1) to excellent (=5)) During procedure, less than 1 hour
Secondary Number of Participants With Correct Placement of Mask It is checked if the mask is placed above the vocal cords (yes/no) During procedure, less than 1 hour
Secondary Number of Participants Where Tip of the Mask is Folded After insertion of the mask, it is assessed by bronchoscopy whether the tip of the mask is folded. Folded tip= Yes, Not folded= No During procedure, less than one hour
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