VivaSight Double Lumen Tube for Single Lung Ventilation

The University of Texas System (UT) logo

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

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

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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