VivaSight Left-sided Double Lumen Tube Study

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)

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.

Study Overview

• Status: Completed
• Conditions: Intubation, Intratracheal
• Intervention / Treatment: Device: intubation with VivaSight double-lumen tube; Procedure: fiberoptic bronchoscopy; Device: intubation with standard double-lumen tube

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.	Procedure: fiberoptic bronchoscopy; Device: intubation with standard double-lumen tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intubation time	We will compare the intubation time for the VivaSight double-lumen tube (DLT) with the intubation time for standard DLT.	Within 5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Picture reliability of the embedded camera of VivaSight double-lumen tube	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.	Within 10 hours

Collaborators and Investigators

• Sponsor: Javier H Campos
• Investigators: Principal Investigator: Javier H Campos, MD, University of Iowa Hospitals & Clinics

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 10, 2013
• Primary Completion (ACTUAL): March 21, 2014
• Study Completion (ACTUAL): March 21, 2014

Study Registration Dates

• First Submitted: September 4, 2018
• First Submitted That Met QC Criteria: September 7, 2018
• First Posted (ACTUAL): September 11, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 11, 2018
• Last Update Submitted That Met QC Criteria: September 7, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: double-lumen endotracheal tube; VivaSight double-lumen tube
• Other Study ID Numbers: 201302811

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Time Frame: IPD will be available for sharing immediately after publication and ending 5 years following article publication.
• IPD Sharing Access Criteria: IPD will be accessible to researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No