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Completed

NCT Number: NCT04128527

AuraOnce Performance Observation

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.

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Key information

Conditions

Anesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rigshospitalet

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placement of laryngeal mask

Device

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

Primary outcomes

  1. Number of Participants With Leakage Observed During Procedure

    Time frame: During procedure, less than 1 hour

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

Secondary outcomes

  1. 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 insertion on a 5-point scale (very difficult (=1) to very easy (=5))

  2. 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 ease of obtaining seal on a 5-point scale (very difficult (=1) to very easy (=5))

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

  4. Number of Participants With Correct Placement of Mask

    Time frame: During procedure, less than 1 hour

    It is checked if the mask is placed above the vocal cords (yes/no)

  5. Number of Participants Where Tip of the Mask is Folded

    Time frame: During procedure, less than one hour

    After insertion of the mask, it is assessed by bronchoscopy whether the tip of the mask is folded. Folded tip= Yes, Not folded= No

Sponsors and collaborators

Lead sponsor

Ambu A/S

Industry

Registry information

Official study title

Prospective Non-interventional Evaluation of Insertion and Sealing Performance of AuraOnce Disposable Laryngeal Mask US Version

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 16, 2019
Registry last updated
Nov 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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