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

NCT03661229 | Terminated

• 1 other identifier: 112553
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

End-stage Renal Disease

Keywords

CVInsight; Hemodialysis; Cardiovascular stress

Outcome Measures

Primary Outcomes (5)

• 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

  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

  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

  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

  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

  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 Outcomes (3)

• Early detection of hemodialysis-induced circulatory stress using the CVInsight System

  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

  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

  Before the dialysis session and 15 minutes prior to the end of the dialysis session for two separate visits within the same week.

Study Arms (1)

CVInsight Monitoring

EXPERIMENTAL

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

Device: CVInsight Monitoring

Interventions

CVInsight Monitoring DEVICE

All participants (n=50) will receive CVInsight non-contact device and CVInsight contact device application during two of their regularly scheduled dialysis sessions.

CVInsight Monitoring

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Intelomed, Inc.: collaborator

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Christopher McIntyre, MBBS DM

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Medical Biophysics and Paediatrics, Robert Lindsay Chair of Dialysis Research and Innovation

Model Details: 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.

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: September 7, 2018
• Study Start: October 21, 2018
• Primary Completion: October 8, 2020
• Study Completion: October 8, 2020
• Last Updated: August 19, 2021

Record last verified: 2021-08

Locations

CA (1)