Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placement of laryngeal mask | Device | All participants are experienced in placement of laryngeal masks and placement will be performed according to standard clinical practice. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Investigator Evaluation of Ease of Obtaining Seal on a 5-point Scale (Very Difficult (=1) to Very Easy (=5)) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
- Subjects where use of AuraOnce cannot be clinically justified
Not provided
Not provided
Not provided
Patients planned for a diagnostic flexible bronchoscopy procedure in general anaesthesia using a laryngeal mask.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Copenhagen | 2100 | Denmark |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Adults, Laryngeal Mask | Adult patients already scheduled for a diagnostic flexible bronchoscopy procedure in general anesthesia using a laryngeal mask. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
No baseline data was collected on participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Adults, Laryngeal Mask | Adult patients (> 18 years) already scheduled for a diagnostic flexible bronchoscopy procedure in general anesthesia using a laryngeal mask. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Continuous Age Data were not collected |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Leakage Observed During Procedure | Is leakage observed (yes/no) if yes, insert signs of leakage | Posted | Count of Participants | Participants | During procedure, less than 1 hour |
|
|
Data collected over the course of one month, Adverse Events assessed during each procedure (less than 1 hour)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adults, Laryngeal Mask | Adult patients already scheduled for a diagnostic flexible bronchoscopy procedure in general anesthesia using a laryngeal mask. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Signe Toräng | Ambu | 31267089 | sito@ambu.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 7, 2019 | Apr 29, 2021 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
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)) | 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 | It is checked if the mask is placed above the vocal cords (yes/no) | 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 | During procedure, less than one hour |
| years |
| Sex: Female, Male | Sex/gender data were not collected | Sex/Gender data were not collected |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. |
|
| 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)) | Posted | Mean | Standard Deviation | score on a scale | 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)) | Posted | Mean | Standard Deviation | score on a scale | 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)) | Posted | Mean | Standard Deviation | score on a scale | 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) | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | During procedure, less than one hour |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
Not provided