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VivaSight Double Lumen Tube for Single Lung Ventilation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03690284
Recruitment Status : Completed
First Posted : October 1, 2018
Results First Posted : December 23, 2021
Last Update Posted : January 14, 2022
Sponsor:
Information provided by (Responsible Party):
Tiffany B Moon, University of Texas Southwestern Medical Center

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Double Lumen Endotracheal Tube Single Lung Ventilation Device: Conventional Double Lumen Tube Device: VivaSight Double Lumen Tube Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: The VivaSight Double Lumen Tube Versus Conventional Double Lumen Tube in Thoracic Surgical Patients
Actual Study Start Date : June 19, 2019
Actual Primary Completion Date : December 31, 2020
Actual Study Completion Date : December 31, 2020
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. The Cost of Double Lumen Tube Intubation [ Time Frame: Intraoperative ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03690284


Locations
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United States, Texas
Parkland Health & Hospital System
Dallas, Texas, United States, 75235
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Tiffany Moon, MD University of Texas Southwestern Medical Center
  Study Documents (Full-Text)

Documents provided by Tiffany B Moon, University of Texas Southwestern Medical Center:
Study Protocol, Statistical Analysis Plan, and Informed Consent Form  [PDF] June 18, 2019

More Information
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Publications:

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Responsible Party: Tiffany B Moon, Associate Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03690284    
Other Study ID Numbers: STU-2018-0098
First Posted: October 1, 2018    Key Record Dates
Results First Posted: December 23, 2021
Last Update Posted: January 14, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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