VivaSight Left-sided Double Lumen Tube Study

NCT03665896 | Completed

• 1 other identifier: 201302811
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Intubation, Intratracheal

Keywords

double-lumen endotracheal tube; VivaSight double-lumen tube

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Picture reliability of the embedded camera of VivaSight double-lumen tube

  Within 10 hours

Study Arms (2)

VivaSight DLT group

ACTIVE COMPARATOR

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

Standard DLT group

PLACEBO COMPARATOR

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

Interventions

intubation with VivaSight double-lumen tube DEVICE

VivaSight DLT group

intubation with standard double-lumen tube DEVICE

Standard DLT group

fiberoptic bronchoscopy PROCEDURE

Standard DLT group; VivaSight DLT group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Javier H Campos: lead

MeSH Terms

Interventions

Intubation

Intervention Hierarchy (Ancestors)

Therapeutics; Investigative Techniques

Study Officials

• Javier H Campos, MD

  University of Iowa Hospitals & Clinics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 11, 2018
• Study Start: July 10, 2013
• Primary Completion: March 21, 2014
• Study Completion: March 21, 2014
• Last Updated: September 11, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.