VivaSight Double Lumen Tube for Single Lung Ventilation

Study Overview
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Brief Summary
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This prospective, randomized, comparative study is intended to enroll a total of 50 patients undergoing thoracic surgery that necessitates single lung ventilation. The efficacy and performance of the VivaSight DLT will be compared to the conventional double lumen tube. Use of fiberoptic bronchoscopy for initial tube positioning and subsequently during the case will be recorded. The attending thoracic surgeon will judge the quality of lung deflation. The occurrence of any malposition and subsequent maneuvers will be recorded. A standardized anesthetic protocol that is usual and customary for the type of operation the patient is having will be provided to the anesthesia teams of enrolled subjects. The remainder of the anesthetic care of the subject will not deviate from the standard of care.

Official Title
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The VivaSight Double Lumen Tube Versus Conventional Double Lumen Tube in Thoracic Surgical Patients

Conditions
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Double Lumen Endotracheal Tube, Single Lung Ventilation

Intervention / Treatment
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* Device: Conventional Double Lumen Tube
* Device: VivaSight Double Lumen Tube


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-90 years old Scheduled for a thoracic surgery that requires single lung ventilation Willing and able to consent in English or Spanish Exclusion Criteria: Age less than 18 or older than 90 Patient does not speak English or Spanish Patient refusal Pregnant or nursing women Known or suspected difficult airway Contraindication for left sided double lumen tube (e.g, L bronchial mass)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional Double Lumen Tube<br>Patient will be intubated with conventional double lumen endotracheal tube for single lung ventilation during thoracic surgery. | Device: Conventional Double Lumen Tube<br>* Patient will be intubated with Mallinckrodt Double Lumen endotracheal tube for single lung ventilation during thoracic surgery<br>|
| Experimental: VivaSight Double Lumen Tube<br>Patient will be intubated with VivaSight double lumen endotracheal tube for single lung ventilation during thoracic surgery. | Device: VivaSight Double Lumen Tube<br>* Patient will be intubated with the VivaSight double lumen endotracheal tube with an integrated camera for single lung ventilation during thoracic surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Requiring Flexible Fiberoptic Bronchoscopy | The number of participants requiring flexible fiberoptic bronchoscopy during double-lumen tube intubation for a single lung ventilation. | Intraoperative, within the time the double lumen was in the trachea | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Intubation Time | The time required to place double lumen endotracheal tube for a single lung intubation | Intraoperative, time to successfully intubate patient. | 
| Number of Participants With Malposition | The number of participants with malposition of double lumen tube for a single lung intubation | Intraoperative, within the time the double lumen was in the trachea | 
| The Cost of Double Lumen Tube Intubation |  | Intraoperative |