Cardiovascular and Respiratory Assessment Using Biometric Signals in a Non-contact Monitoring Device

August 15, 2021 updated by: Chris McIntyre, Lawson Health Research Institute
Patients on hemodialysis treatment experience increased levels of cardiovascular disease. In this study, investigators will be detecting hemodialysis induced circulatory stress using the CVInsight Patient Monitoring & Informatics System - InteloMed. This system consists of the CVInsight non-contact device and the CVInsight contact device that measures a patient's response to dialysis by looking at many physiological parameters such as heart rate, heart rate variability, respiratory rate, and how much oxygen the blood is carrying. Investigators would like to validate the mobile CVInsight non-contact device to the currently used standard CVInsight contact device to provide healthcare providers with a better understanding of its role in early detection of cardiovascular stress induced by hemodialysis.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This observational validation trial involves patients from the prevalent dialysis population in London, Ontario. Investigators intend to validate the mobile CVInsight non-contact device to the standard contact version of this device for assessing hemodialysis induced circulatory stress. The CVInsight Patient Monitoring & Informatics System records a patient's pulse waveform to determine a patient's response to dialysis and alerts to several physiologic changes including pulse strength, pulse rate, pulse irregularity, oxygen saturation, and oxygen saturation variability. The CVInsight contact and non-contact devices will be used for two study visits. The first study visit will be on the patient's first dialysis session of the week (after the weekend - 72 hour inter-dialytic period) and the second study visit will be during the patient's second dialysis session of the week (mid week - 48 hour inter-dialytic period). This will allow investigators to see if there is a difference between these two intervals of time. The investigators will also be using other gold standard methods of validating components of this device including myocardial stunning using the GE Healthcare Vivid q cardiovascular ultrasound system. The echocardiographic ultrasound machine and finometer will be used for two study visits to take place during the patients' regularly scheduled dialysis sessions. The first echocardiogram will be done prior to the initiation of dialysis and the second at peak dialysis stress, which is 15 minutes before the end of the hemodialysis treatment. In addition, the finometer will be used continuously throughout hemodialysis.Validating the mobile CVInsight non-contact device to the CVInsight contact device will allow investigators to observe the degree to which these devices are able to detect hemodialysis induced circulatory stress, which will enable the healthcare provider to detect injury early enough to intervene prior to its occurrence. This is important because hemodialysis and the accompanying stress it induces increases mortality significantly in this population of patients.

This study is investigator initiated and the study will continue until the investigators reach our target sample size.

Each patient will have two study visits. Patients on a Monday, Wednesday, and Friday schedule will have study visits on Monday and Wednesday of the same week and patients on a Tuesday, Thursday, and Saturday schedule will have study visits on Tuesday and Thursday of the same week.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • London Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients receiving conventional thrice weekly maintenance HD
  • Age ≥18 years
  • Able to provide informed consent

Exclusion Criteria:

• Not meeting inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CVInsight Monitoring
Single group arm: All participants receive the same intervention/treatment CVInsight non-contact device and CVInsight contact device application.
Device: CVInsight Monitoring
All participants (n=50) will receive CVInsight non-contact device and CVInsight contact device application during two of their regularly scheduled dialysis sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mobile CVInsight validation against the CVInsight contact device by recording pulse rate trends
Time Frame: Through dialysis session, an average of 4 hours for two separate visits within the same week.
Validation of the mobile CVInsight with pulse rate from the CVInsight contact device
Through dialysis session, an average of 4 hours for two separate visits within the same week.
Mobile CVInsight validation against the CVInsight contact device by recording pulse strength
Time Frame: Through dialysis session, an average of 4 hours for two separate visits within the same week.
Validation of the mobile CVInsight with pulse strength (derived from a photoelectric plethysmograph waveform) from the CVInsight contact device
Through dialysis session, an average of 4 hours for two separate visits within the same week.
Mobile CVInsight validation against the CVInsight contact device by recording pulse irregularity
Time Frame: Through dialysis session, an average of 4 hours for two separate visits within the same week.
Validation of the mobile CVInsight with pulse irregularity (derived from the pulse wave signal) from the CVInsight contact device
Through dialysis session, an average of 4 hours for two separate visits within the same week.
Mobile CVInsight validation against the CVInsight contact device by recording oxygen saturation
Time Frame: Through dialysis session, an average of 4 hours for two separate visits within the same week.
Validation of the mobile CVInsight with the percentage of oxygen carried in blood from the CVInsight contact device
Through dialysis session, an average of 4 hours for two separate visits within the same week.
Mobile CVInsight validation against the CVInsight contact device by recording oxygen saturation variability
Time Frame: Through dialysis session, an average of 4 hours for two separate visits within the same week.
Validation of the mobile CVInsight with the oxygen saturation variability (derived from the oximeter signal) from the CVInsight contact device
Through dialysis session, an average of 4 hours for two separate visits within the same week.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early detection of hemodialysis-induced circulatory stress using the CVInsight System
Time Frame: Through dialysis session, an average of 4 hours for two separate visits within the same week.
The secondary outcome will be assessment of the contact and non-contact CVInsight devices on hemodialysis induced circulatory stress
Through dialysis session, an average of 4 hours for two separate visits within the same week.
Early detection of hemodialysis-induced circulatory stress using the finometer
Time Frame: Through dialysis session, an average of 4 hours for two separate visits within the same week.
The secondary outcome will be assessment of the finometer on hemodialysis induced circulatory stress
Through dialysis session, an average of 4 hours for two separate visits within the same week.
Early detection of hemodialysis-induced circulatory stress using echocardiography
Time Frame: Before the dialysis session and 15 minutes prior to the end of the dialysis session for two separate visits within the same week.
The secondary outcome will be assessment of echocardiography on hemodialysis induced circulatory stress
Before the dialysis session and 15 minutes prior to the end of the dialysis session for two separate visits within the same week.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Collaborators

Intelomed, Inc.

Investigators

  • Principal Investigator: Christopher McIntyre, MBBS DM, London Health Sciences Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2018

Primary Completion (Actual)

October 8, 2020

Study Completion (Actual)

October 8, 2020

Study Registration Dates

First Submitted

August 22, 2018

First Submitted That Met QC Criteria

September 4, 2018

First Posted (Actual)

September 7, 2018

Study Record Updates

Last Update Posted (Actual)

August 19, 2021

Last Update Submitted That Met QC Criteria

August 15, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 112553

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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