VivaSight Double Lumen Tube for Single Lung Ventilation

The University of Texas System (UT)

Status: Completed

Conditions: Double Lumen Endotracheal Tube; Single Lung Ventilation

Treatments: Device: Conventional Double Lumen Tube; Device: VivaSight Double Lumen Tube

Study type: Interventional

Funder types: Other

Identifiers

NCT03690284

STU-2018-0098

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Conventional Double Lumen Tube

Active Comparator group

Description:

Patient will be intubated with conventional double lumen endotracheal tube for single lung ventilation during thoracic surgery.

Treatment:

Device: Conventional Double Lumen Tube

VivaSight Double Lumen Tube

Experimental group

Description:

Patient will be intubated with VivaSight double lumen endotracheal tube for single lung ventilation during thoracic surgery.

Treatment:

Device: VivaSight Double Lumen Tube