Double-lumen Tubes (DLT) - Health Economic Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Controlled Study Comparing the VivaSight Double-lumen Tube With a Conventional Double-lumen Tube in Adult Patients Undergoing Thoracic Surgery

Conditions
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Single Lung Ventilation, Thoracic Surgery, Anesthesia, Cost-effectiveness

Intervention / Treatment
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* Procedure: VivaSight double-lumen tube for single-lung ventilation
* Procedure: Conventional double-lument tube for single-lung ventilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Oral explanation of the investigation and Patient Information has been given to the subject or legal representative The subject or legal representative has signed the Informed Consent The subject is admitted at Odense University Hospital (OUH), department V Subjects evaluated as eligible for single-lung ventilation with the use of a left sided DLT Subjects > 18 years of age Exclusion Criteria: Subjects with known tracheobronchial anatomic anomalies Subjects going for emergency procedures Subjects with anticipated difficult airways Subjects with known tracheal pathology Subjects requiring rapid sequence induction Surgeries in which other lung isolation devices or techniques may be warranted (e.g. tracheostomy, nasal intubation, bronchial blockers) Subjects who cannot be intubated with a double-lumen tube (VivaSight-DL or conventional DLT) Subjects requiring a right-sided DLT Subjects who had participated in the study before

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VivaSight double-lumen tube<br> | Procedure: VivaSight double-lumen tube for single-lung ventilation<br>* Procedure using a tube with a camera<br>|
| Active Comparator: Conventional double-lumen tube<br> | Procedure: Conventional double-lument tube for single-lung ventilation<br>* Procedure using a tube without a camera<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Times Bronchoscope is Used |  | During procedure, up to 4 hours | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 |