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The aim of this study is to make a health economic evaluation comparing novice physicians use of VivaSight double-lumen tube and a conventional double-lumen tube for single-lung ventilation during thoracic surgery at a teaching hospital. The hypothesis is, that both double-lumen tubes are equally cost-effective and the the incidence of fiberoptic bronchoscope use it the same for both tubes.
A randomized, controlled single-centre investigation comparing the VivaSight double-lumen tube and the conventional double-lumen tube at a teaching hospital. A pilot study including up to 10 subjects will be performed prior to the investigation is initiated. The investigation will include a total of 50 adult subjects (25 subjects in each group) admitted to the investigational site with established indication of single lung ventilation.
The objective of the investigation is to compare the number of times the tube position needs to be verified with a scope and relevant costs between VivaSight double lumen tube and conventional double lument tube in a cost-effectiveness analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VivaSight double-lumen tube | Experimental |
| |
| Conventional double-lumen tube | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VivaSight double-lumen tube for single-lung ventilation | Procedure | Procedure using a tube with a camera |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Times Bronchoscope is Used | During procedure, up to 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Intubation Time | During procedure, up to 4 hours | |
| Number of Intubation Attempts | During procedure, up to 4 hours | |
| Number of Time the Tube Was Repositioned |
| Measure | Description | Time Frame |
|---|---|---|
| Obtain User Perspective of the Device (VivaSight Double Lumen Tube or Conventional Double Lumen Tube) Used During Procedure. | Qualitative assessment (face-validated and testet during pilot test) using a five-point scale (1: very easy/very good, 3: acceptable, 5: very difficult/very poor) | During procedure, up to 4 hours |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odense University Hospital | Odense | 5000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31297752 | Background | Larsen S, Holm JH, Sauer TN, Andersen C. A Cost-Effectiveness Analysis Comparing the VivaSight Double-Lumen Tube and a Conventional Double-Lumen Tube in Adult Patients Undergoing Thoracic Surgery Involving One-Lung Ventilation. Pharmacoecon Open. 2020 Mar;4(1):159-169. doi: 10.1007/s41669-019-0163-y. |
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Data will described in groups
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| ID | Title | Description |
|---|---|---|
| FG000 | VivaSight Double-lumen Tube | VivaSight double-lumen tube for single-lung ventilation: Procedure using a tube with a camera |
| FG001 | Conventional Double-lumen Tube | Conventional double-lument tube for single-lung ventilation: Procedure using a tube without a camera |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | VivaSight Double-lumen Tube | VivaSight double-lumen tube for single-lung ventilation: Procedure using a tube with a camera |
| BG001 | Conventional Double-lumen Tube | Conventional double-lument tube for single-lung ventilation: Procedure using a tube without a camera |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Times Bronchoscope is Used | Posted | Mean | Standard Deviation | Reported uses of bronchoscopes | During procedure, up to 4 hours |
|
|
Up to 48 hours post procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VivaSight Double-lumen Tube | VivaSight double-lumen tube for single-lung ventilation: Procedure using a tube with a camera |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anna Charlotte Lundgaard | Ambu A/S | +4529643748 | aclu@ambu.com |
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| 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 | Jun 26, 2018 | Feb 3, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D061810 | One-Lung Ventilation |
| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
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| Conventional double-lument tube for single-lung ventilation | Procedure | Procedure using a tube without a camera |
|
| During procedure, up to 4 hours |
| Number of Times Repositioning of the Tube Was Prevented | During procedure, up to 4 hours |
| Cost Per Procedure | An average of 1 year |
| Patient Reported Post Operative Outcomes |
Qualitative assessment (face-validated and testet during pilot test) using a questionnaire registrering postoperative outcomes (Yes/No) and degree of postoperative outcomes (mild/moderate/severe) |
| Within 48 hours after the procedure |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| Surgical lung | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Intubation Time | Not Posted | During procedure, up to 4 hours | Participants |
| Secondary | Number of Intubation Attempts | Not Posted | During procedure, up to 4 hours | Participants |
| Secondary | Number of Time the Tube Was Repositioned | Not Posted | During procedure, up to 4 hours | Participants |
| Secondary | Number of Times Repositioning of the Tube Was Prevented | Not Posted | During procedure, up to 4 hours | Participants |
| Secondary | Cost Per Procedure | Not Posted | An average of 1 year | Participants |
| Other Pre-specified | Obtain User Perspective of the Device (VivaSight Double Lumen Tube or Conventional Double Lumen Tube) Used During Procedure. | Qualitative assessment (face-validated and testet during pilot test) using a five-point scale (1: very easy/very good, 3: acceptable, 5: very difficult/very poor) | Not Posted | During procedure, up to 4 hours | Participants |
| Other Pre-specified | Patient Reported Post Operative Outcomes | Qualitative assessment (face-validated and testet during pilot test) using a questionnaire registrering postoperative outcomes (Yes/No) and degree of postoperative outcomes (mild/moderate/severe) | Not Posted | Within 48 hours after the procedure | Participants |
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Conventional Double-lumen Tube | Conventional double-lument tube for single-lung ventilation: Procedure using a tube without a camera | 0 | 22 | 0 | 22 | 0 | 22 |
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