NCT03690284

VivaSight Double Lumen Tube for Single Lung Ventilation

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Double Lumen Endotracheal Tube
• Single Lung Ventilation

Interventions

Type	Name	Description
DEVICE	Conventional Double Lumen Tube	Patient will be intubated with Mallinckrodt Double Lumen endotracheal tube for single lung ventilation during thoracic surgery
DEVICE	VivaSight Double Lumen Tube	Patient will be intubated with the VivaSight double lumen endotracheal tube with an integrated camera for single lung ventilation during thoracic surgery

Timeline

• Start date: 2019-06-19
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2018-10-01
• Last updated: 2022-01-14
• Results posted: 2021-12-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study