VivaSight Left-sided Double Lumen Tube Study

NCT ID: NCT03665896

Last Updated: 2018-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-10
• Study Completion Date: 2014-03-21

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.

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.

Conditions

Intubation, Intratracheal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

intubation with VivaSight double-lumen tube

Intervention Type: DEVICE

fiberoptic bronchoscopy

Intervention Type: PROCEDURE

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.

Group Type: PLACEBO_COMPARATOR

intubation with standard double-lumen tube

Intervention Type: DEVICE

fiberoptic bronchoscopy

Intervention Type: PROCEDURE

Interventions

intubation with VivaSight double-lumen tube

Intervention Type: DEVICE

intubation with standard double-lumen tube

Intervention Type: DEVICE

fiberoptic bronchoscopy

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Javier H Campos

OTHER

Sponsor Role: lead

Responsible Party

Javier H Campos

Principle Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Javier H Campos, MD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa Hospitals & Clinics

Other Identifiers

201302811

Identifier Type: -

Identifier Source: org_study_id