A Comparison of the Performance of Standard Double Lumen Tubes With Vivasight DL™ Double Lumen Tubes for Lung Isolation in Patients Undergoing Thoracic Surgery

Study Overview
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Brief Summary
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The investigators have performed a number of studies on novel airway devices. In this randomized controlled trial he investigators would like to compare the performance of a new double-lumen endotracheal tube incorporating internal camera (Vivasight DL) with a standard double lumen tube.

Detailed Description
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Single lung ventilation is frequently carried out to facilitate surgery on the lungs and pleura. In most instances this is achieved by insertion of a double-lumen endotracheal tube and then selectively ventilating one lung or both. Precise positioning of these tubes is essential for optimal performance. It has become the standard of care to perform bronchoscopy to confirm tube position. A new double lumen endotracheal tube (Vivasight DL) has recently been developed. It has all the features of a standard double lumen endotracheal tube but also incorporates an internal camera which, when connected to an external screen, allows continuous confirmation of tube position. This is randomized, single blinded controlled trial. The participants will be allocated to two study groups (Vivasight DL or standard DLT), in which the primary airway management device will be respectively Vivasight DL double lumen tube or a standard double lumen endotracheal tube. Clinical Research Ethics Committee approval has been obtained. Suitable participants will be recruited after written informed consent. Standard anesthetic preassessment and anesthesia will be provided. Consenting patients passing the inclusion and exclusion criteria will be randomly allocated to either of the 2 study groups. Protocol for attempts at placement and tube position confirmation will be followed. The investigators will monitor a number of parameters, including time and ease of tube insertion, ability to verify tube position with the primary imaging modality for each group, need to perform tube position adjustment maneuvers, need to use fiberoptic bronchoscope during the case, quality of lung collapse, problems with ventilation and other. The primary hypothesis is that the new Vivasight DL tube system will provide a comparable optical view to the fiberoptic scope view obtained via standard double lumen endotracheal tube in order to confirm optimal position.

Official Title
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A Comparison of the Performance of Standard Double Lumen Tubes With Vivasight DL™ Double Lumen Tubes for Lung Isolation in Patients Undergoing Thoracic Surgery

Conditions
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Performance and Safety of an Airway Management Device

Intervention / Treatment
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* Device: double lumen endotracheal tube placement and use


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 16 - 85 yr old patients capable of informed consent ASA (American Society of Anesthesiologists physical status) 1-3 non-emergency surgery of expected duration < 6 hours one-lung ventilation required Exclusion Criteria: BMI > 35 expected difficult airway Mallampati score >2 increased risk of aspiration upper airway or upper GI problems live pregnancy

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 85 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vivasight DL<br>placement and intraoperative use of Vivasight DL double lumen endobronchial tube | Device: double lumen endotracheal tube placement and use<br> <br> |
| Active Comparator: standard DLT<br>placement and intraoperative use of a standard double lumen endotracheal tube. | Device: double lumen endotracheal tube placement and use<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adequacy of optical view obtained to confirm optimal tube position. | The hypothesis is that the new Vivasight DL tube system will provide a comparable optical view to the fiberoptic scope view obtained via standard double lumen endotracheal tube in order to confirm optimal position. | within 60 minutes of commencement of general anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to confirmation of tube position |  | within 60 minutes of commencement of general anesthesia | 
| Operator rated Device Difficulty Score | The investigators will use 10cm visual analogue scale (VAS) to rate the overall ease of device use till successful placement achieved and position confirmed optically. | within 60 minutes of commencement of general anesthesia | 
| Time from initial laryngoscopy to passing tube through vocal cords |  | Within 60 minutes of commencement of general anesthesia | 
| rate of malposition | the investigators will record the number/type of tube position adjustment maneuvers | within 15 hours of commencement of general anesthesia | 
| need to pass a fiberoptic bronchoscope during case |  | within 15 hours of commencement of general anesthesia | 
| presence of blood at the carina immediately post intubation |  | within 60 minutes of commencement of general anesthesia | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vivasight DL, double lumen endotracheal tube, fiberoptic confirmation of tube position