Trials / Completed
CompletedNCT03817879
Double-lumen Tubes (DLT) - Health Economic Study
A Randomized Controlled Study Comparing the VivaSight Double-lumen Tube With a Conventional Double-lumen Tube in Adult Patients Undergoing Thoracic Surgery
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 70 (actual)
- Sponsor
- Ambu A/S · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | VivaSight double-lumen tube for single-lung ventilation | Procedure using a tube with a camera |
| PROCEDURE | Conventional double-lument tube for single-lung ventilation | Procedure using a tube without a camera |
Timeline
- Start date
- 2018-11-02
- Primary completion
- 2019-01-31
- Completion
- 2019-01-31
- First posted
- 2019-01-28
- Last updated
- 2020-02-13
- Results posted
- 2020-02-13
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT03817879. Inclusion in this directory is not an endorsement.