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

Primary Purpose

End-stage Renal Disease

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
CVInsight Monitoring
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for End-stage Renal Disease focused on measuring CVInsight, Hemodialysis, Cardiovascular stress

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

• Not meeting inclusion criteria

Sites / Locations

  • London Health Sciences Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CVInsight Monitoring

Arm Description

Single group arm: All participants receive the same intervention/treatment CVInsight non-contact device and CVInsight contact device application.

Outcomes

Primary Outcome Measures

Mobile CVInsight validation against the CVInsight contact device by recording pulse rate trends
Validation of the mobile CVInsight with pulse rate from the CVInsight contact device
Mobile CVInsight validation against the CVInsight contact device by recording pulse strength
Validation of the mobile CVInsight with pulse strength (derived from a photoelectric plethysmograph waveform) from the CVInsight contact device
Mobile CVInsight validation against the CVInsight contact device by recording pulse irregularity
Validation of the mobile CVInsight with pulse irregularity (derived from the pulse wave signal) from the CVInsight contact device
Mobile CVInsight validation against the CVInsight contact device by recording oxygen saturation
Validation of the mobile CVInsight with the percentage of oxygen carried in blood from the CVInsight contact device
Mobile CVInsight validation against the CVInsight contact device by recording oxygen saturation variability
Validation of the mobile CVInsight with the oxygen saturation variability (derived from the oximeter signal) from the CVInsight contact device

Secondary Outcome Measures

Early detection of hemodialysis-induced circulatory stress using the CVInsight System
The secondary outcome will be assessment of the contact and non-contact CVInsight devices on hemodialysis induced circulatory stress
Early detection of hemodialysis-induced circulatory stress using the finometer
The secondary outcome will be assessment of the finometer on hemodialysis induced circulatory stress
Early detection of hemodialysis-induced circulatory stress using echocardiography
The secondary outcome will be assessment of echocardiography on hemodialysis induced circulatory stress

Full Information

First Posted
August 22, 2018
Last Updated
August 15, 2021
Sponsor
Lawson Health Research Institute
Collaborators
Intelomed, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03661229
Brief Title
Cardiovascular and Respiratory Assessment Using Biometric Signals in a Non-contact Monitoring Device
Official Title
Cardiovascular and Respiratory Assessment Using Biometric Signals in a Non-contact Monitoring Device
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
Inability to demonstrate efficacy. The reason for this is that we were unable to get the necessary information from our population of dialysis patient using the mCVI™ non-contact facial tracking cell phone app.
Study Start Date
October 21, 2018 (Actual)
Primary Completion Date
October 8, 2020 (Actual)
Study Completion Date
October 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute
Collaborators
Intelomed, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-stage Renal Disease
Keywords
CVInsight, Hemodialysis, Cardiovascular stress

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Up to 50 patients will be assessed using the CVInsight Monitoring System. Patients will undergo two consecutive hemodialysis (HD) treatments where they will be monitored with the contact and non-contact devices throughout their HD session. The first visit will be on their first HD session of the week (after the weekend - 72 hour inter-dialytic period) and the second visit will be during the patient's second HD session of the week (mid-week - 48 hour inter-dialytic period). This will allow us to see if there is a difference between these two intervals of time. Twenty of these patients will have additional monitoring including movement of left ventricle using echocardiography and continuous blood pressure monitoring using a finometer. The first echocardiogram will be done prior to the initiation of HD and the second at peak HD stress, which is 15 minutes before the end of the HD treatment. 20/50 patients will be chosen according to patient treatment schedule and staff schedule.
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CVInsight Monitoring
Arm Type
Experimental
Arm Description
Single group arm: All participants receive the same intervention/treatment CVInsight non-contact device and CVInsight contact device application.
Intervention Type
Device
Intervention Name(s)
CVInsight Monitoring
Intervention Description
All participants (n=50) will receive CVInsight non-contact device and CVInsight contact device application during two of their regularly scheduled dialysis sessions.
Primary Outcome Measure Information:
Title
Mobile CVInsight validation against the CVInsight contact device by recording pulse rate trends
Description
Validation of the mobile CVInsight with pulse rate from the CVInsight contact device
Time Frame
Through dialysis session, an average of 4 hours for two separate visits within the same week.
Title
Mobile CVInsight validation against the CVInsight contact device by recording pulse strength
Description
Validation of the mobile CVInsight with pulse strength (derived from a photoelectric plethysmograph waveform) from the CVInsight contact device
Time Frame
Through dialysis session, an average of 4 hours for two separate visits within the same week.
Title
Mobile CVInsight validation against the CVInsight contact device by recording pulse irregularity
Description
Validation of the mobile CVInsight with pulse irregularity (derived from the pulse wave signal) from the CVInsight contact device
Time Frame
Through dialysis session, an average of 4 hours for two separate visits within the same week.
Title
Mobile CVInsight validation against the CVInsight contact device by recording oxygen saturation
Description
Validation of the mobile CVInsight with the percentage of oxygen carried in blood from the CVInsight contact device
Time Frame
Through dialysis session, an average of 4 hours for two separate visits within the same week.
Title
Mobile CVInsight validation against the CVInsight contact device by recording oxygen saturation variability
Description
Validation of the mobile CVInsight with the oxygen saturation variability (derived from the oximeter signal) from the CVInsight contact device
Time Frame
Through dialysis session, an average of 4 hours for two separate visits within the same week.
Secondary Outcome Measure Information:
Title
Early detection of hemodialysis-induced circulatory stress using the CVInsight System
Description
The secondary outcome will be assessment of the contact and non-contact CVInsight devices on hemodialysis induced circulatory stress
Time Frame
Through dialysis session, an average of 4 hours for two separate visits within the same week.
Title
Early detection of hemodialysis-induced circulatory stress using the finometer
Description
The secondary outcome will be assessment of the finometer on hemodialysis induced circulatory stress
Time Frame
Through dialysis session, an average of 4 hours for two separate visits within the same week.
Title
Early detection of hemodialysis-induced circulatory stress using echocardiography
Description
The secondary outcome will be assessment of echocardiography on hemodialysis induced circulatory stress
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.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients receiving conventional thrice weekly maintenance HD Age ≥18 years Able to provide informed consent Exclusion Criteria: • Not meeting inclusion criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher McIntyre, MBBS DM
Organizational Affiliation
London Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada

12. IPD Sharing Statement

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

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