Anesthesia
Conditions
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.
Detailed 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.
Interventions
DEVICEPlacement of laryngeal mask
All participants are experienced in placement of laryngeal masks and placement will be performed according to standard clinical practice.
Sponsors
Ambu A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Leakage Observed During Procedure | During procedure, less than 1 hour | Is leakage observed (yes/no) if yes, insert signs of leakage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 insertion 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 | Investigator evaluation of ease of obtaining seal on a 5-point scale (very difficult (=1) to very easy (=5)) |
| Investigator Evaluation of Overall Performance on a 5-point Scale (Very Bad (=1) to Excellent (=5)) | During procedure, less than 1 hour | Investigator evaluation of overall performance on a 5-point scale (very bad (=1) to excellent (=5)) |
| Number of Participants With Correct Placement of Mask | During procedure, less than 1 hour | It is checked if the mask is placed above the vocal cords (yes/no) |
| Number of Participants Where Tip of the Mask is Folded | 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 |
Countries
Denmark
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Adults, Laryngeal Mask Adult patients (\> 18 years) already scheduled for a diagnostic flexible bronchoscopy procedure in general anesthesia using a laryngeal mask. | 0 |
| Total | 0 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 16 |
| other Total, other adverse events | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Adults, Laryngeal Mask | Number of Participants With Leakage Observed During Procedure | 0 Participants |
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))
Time frame: During procedure, less than 1 hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adults, Laryngeal Mask | Investigator Evaluation of Ease of Insertion on a 5-point Scale (Very Difficult (=1) to Very Easy (=5)) | 4.6 score on a scale | Standard Deviation 0.7 |
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))
Time frame: During procedure, less than 1 hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adults, Laryngeal Mask | Investigator Evaluation of Ease of Obtaining Seal on a 5-point Scale (Very Difficult (=1) to Very Easy (=5)) | 4.7 score on a scale | Standard Deviation 0.6 |
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))
Time frame: During procedure, less than 1 hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adults, Laryngeal Mask | Investigator Evaluation of Overall Performance on a 5-point Scale (Very Bad (=1) to Excellent (=5)) | 4.6 score on a scale | Standard Deviation 0.5 |
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
Time frame: During procedure, less than one hour
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Adults, Laryngeal Mask | Number of Participants Where Tip of the Mask is Folded | 0 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Adults, Laryngeal Mask | Number of Participants With Correct Placement of Mask | 16 Participants |