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.
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.
Study Type
OBSERVATIONAL
Enrollment
16
All participants are experienced in placement of laryngeal masks and placement will be performed according to standard clinical practice.
Rigshospitalet
Copenhagen, Denmark
Number of Participants With Leakage Observed During Procedure
Is leakage observed (yes/no) if yes, insert signs of leakage
Time frame: During procedure, less than 1 hour
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))
Time frame: 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))
Investigator evaluation of ease of obtaining seal on a 5-point scale (very difficult (=1) to very easy (=5))
Time frame: During procedure, less than 1 hour
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))
Time frame: During procedure, less than 1 hour
Number of Participants With Correct Placement of Mask
It is checked if the mask is placed above the vocal cords (yes/no)
Time frame: During procedure, less than 1 hour
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
Time frame: During procedure, less than one hour
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