VivaSight Double Lumen Tube for Single Lung Ventilation

January 5, 2022 updated by: Tiffany B Moon, University of Texas Southwestern Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75235
        • Parkland Health & Hospital System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Conventional Double Lumen Tube
Patient will be intubated with conventional double lumen endotracheal tube for single lung ventilation during thoracic surgery.
Device: Conventional Double Lumen Tube
Patient will be intubated with Mallinckrodt Double Lumen endotracheal tube for single lung ventilation during thoracic surgery
EXPERIMENTAL: VivaSight Double Lumen Tube
Patient will be intubated with VivaSight 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Requiring Flexible Fiberoptic Bronchoscopy
Time Frame: Intraoperative, within the time the double lumen was in the trachea
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
Time Frame: Intraoperative, time to successfully intubate patient.
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
Time Frame: Intraoperative, within the time the double lumen was in the trachea
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
Time Frame: Intraoperative
Intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 19, 2019

Primary Completion (ACTUAL)

December 31, 2020

Study Completion (ACTUAL)

December 31, 2020

Study Registration Dates

First Submitted

September 24, 2018

First Submitted That Met QC Criteria

September 27, 2018

First Posted (ACTUAL)

October 1, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 14, 2022

Last Update Submitted That Met QC Criteria

January 5, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • STU-2018-0098

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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