Clinical trial NCT03661229: 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
Overall status: TERMINATED
Phase: NA
Conditions: End-stage Renal Disease
Keywords: CVInsight
Hemodialysis
Cardiovascular stress
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Intelomed, Inc.
First posted: 2018-09-07
Enrollment: 14
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Mobile CVInsight validation against the CVInsight contact device by recording pulse rate trends
timeFrame: Through dialysis session, an average of 4 hours for two separate visits within the same week.
measure: Mobile CVInsight validation against the CVInsight contact device by recording pulse strength
timeFrame: Through dialysis session, an average of 4 hours for two separate visits within the same week.
measure: Mobile CVInsight validation against the CVInsight contact device by recording pulse irregularity
timeFrame: Through dialysis session, an average of 4 hours for two separate visits within the same week.
measure: Mobile CVInsight validation against the CVInsight contact device by recording oxygen saturation
timeFrame: Through dialysis session, an average of 4 hours for two separate visits within the same week.
measure: Mobile CVInsight validation against the CVInsight contact device by recording oxygen saturation variability
timeFrame: Through dialysis session, an average of 4 hours for two separate visits within the same week.
Secondary outcomes:
measure: Early detection of hemodialysis-induced circulatory stress using the CVInsight System
timeFrame: Through dialysis session, an average of 4 hours for two separate visits within the same week.
measure: Early detection of hemodialysis-induced circulatory stress using the finometer
timeFrame: Through dialysis session, an average of 4 hours for two separate visits within the same week.
measure: Early detection of hemodialysis-induced circulatory stress using echocardiography
timeFrame: Before the dialysis session and 15 minutes prior to the end of the dialysis session for two separate visits within the same week.
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: London Health Sciences Centre
name: Christopher McIntyre, MBBS DM
role: PRINCIPAL_INVESTIGATOR
References: