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VivaSight Left-sided Double Lumen Tube Study

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ClinicalTrials.gov Identifier: NCT03665896
Recruitment Status : Completed
First Posted : September 11, 2018
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Javier H Campos, University of Iowa

Brief Summary:

The VivaSight™‐DLT is a new OLV (one lung ventilation) device that contains an embedded camera. Therefore, a potential advantage is the continuous assessment of DLT position through continuous monitoring of the camera. The embedded camera of VivaSight™‐DLT is positioned at the tracheal opening of the double lumen tube. It allows for continuous monitoring of the carina and bronchial tube placement.

The purpose of this study is to determine if a double lumen tube (DLT) with an embedded video camera, the VivaSight DLT, can be used in similar fashion to the standard double lumen tube with fiberoptic bronchoscopy. More specifically, the investigators would like to know the difference in time to optimal position in the left bronchus between the VivaSight DLT and the standard DLT with fiberoptic bronchoscopy. In addition, the investigators would like to know if the embedded camera on the VivaSight DLT provides a view that will allow for the optimum position of the DLT in the left bronchus.


Condition or disease Intervention/treatment Phase
Intubation, Intratracheal Device: intubation with VivaSight double-lumen tube Device: intubation with standard double-lumen tube Procedure: fiberoptic bronchoscopy Not Applicable

Detailed Description:

The investigators will perform a prospective, randomized study in thoracic surgical patients undergoing one-lung ventilation where the patient will receive either the VivaSight DLT or standard left-sided DLT. Subjects will be selected and evaluated who are at least 18 years old, but no older than 90 years old.

The investigators will compare the intubation time for the VivaSight™‐DLT with the intubation time for standard DLT. The intubation time parameters for the VivaSight™‐DLT are the passage of the tube through the vocal cords and the confirmation of proper tube positioning by the embedded camera. Fiberoptic bronchoscopy is performed to reassess the proper tube positioning, however, this will not be counted for the intubation time in this group. For the standard DLT, the intubation time parameter begins similarly, on the passage of the tube through the vocal cords, but ends with the confirmation of the proper placement by fiberoptic bronchoscopy. In both groups, C-MAC blade is used to visualize the passage of the tube through the vocal cords. These intubation times will be tracked real-time in the operating room and will be based upon both observation as well as the verbal confirmation of the attending anesthesiologist.

The intubation time must be within 5 minutes. The intubation time required more than 5 minutes is considered as unsuccessful intubation.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Comparison of Placement With the VivaSight Left-sided Double Lumen Tube With an Integrated Monitor/Camera Versus the Standard Left-sided Double Lumen Tube (DLT) With Fiberoptic Bronchoscopy in Patients Requiring One-lung Ventilation (OLV)
Actual Study Start Date : July 10, 2013
Actual Primary Completion Date : March 21, 2014
Actual Study Completion Date : March 21, 2014

Arm Intervention/treatment
Active Comparator: VivaSight DLT group
Thoracic surgery patient is intubated with VivaSight double-lumen tube (intubation with VivaSight double-lumen tube). The intubation time, duration between the passage of the tube through the vocal cords and the confirmation of proper tube positioning by the embedded camera, is recorded. The tube position is reconfirmed by fiberoptic bronchoscopy.
Device: intubation with VivaSight double-lumen tube
Procedure: fiberoptic bronchoscopy
Placebo Comparator: Standard DLT group
Thoracic surgery patient is intubated with standard double-lumen tube (intubation with standard double-lumen tube). The intubation time, duration between the passage of the tube through the vocal cords and the confirmation of proper tube positioning by fiberoptic bronchoscopy, is recorded.
Device: intubation with standard double-lumen tube
Procedure: fiberoptic bronchoscopy



Primary Outcome Measures :
  1. Intubation time [ Time Frame: Within 5 minutes ]
    We will compare the intubation time for the VivaSight double-lumen tube (DLT) with the intubation time for standard DLT.


Secondary Outcome Measures :
  1. Picture reliability of the embedded camera of VivaSight double-lumen tube [ Time Frame: Within 10 hours ]
    Picture reliability of the embedded camera will be assessed based upon the proper identification of the following structures; a) Carina, b) Left bronchial cuff , c) A radiopaque line of left bronchial tube, d) Right main bronchus.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 years of age
  • Adult patient undergoing scheduled thoracic surgery which requires double-lumen tube placement

Exclusion Criteria:

  • More than 90 years of age
  • Patients with emergency surgery
  • Prisoners
  • Patient who cannot provide their own consent
  • Patient refusal
  • Non-English speaking patients

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): NCT03665896


Sponsors and Collaborators
Javier H Campos
Investigators
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Principal Investigator: Javier H Campos, MD University of Iowa Hospitals & Clinics

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Responsible Party: Javier H Campos, Principle Investigator, University of Iowa
ClinicalTrials.gov Identifier: NCT03665896     History of Changes
Other Study ID Numbers: 201302811
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All of the individual participant data collected during the trial, after deidentification will be shared with researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal. IPD will be available for sharing immediately after publication and ending 5 years following article publication.
Supporting Materials: Study Protocol
Time Frame: IPD will be available for sharing immediately after publication and ending 5 years following article publication.
Access Criteria: IPD will be accessible to researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Javier H Campos, University of Iowa:
double-lumen endotracheal tube
VivaSight double-lumen tube