An interventional study of CVInsight Monitoring in End-stage Renal Disease, sponsored by London Health Sciences Centre OR Lawson Research Institute of St. Joseph's. Terminated at 1 site in Canada. Per ClinicalTrials.gov, last updated 2021-08-19.
Sponsored by London Health Sciences Centre OR Lawson Research Institute of St. Joseph's · Not applicable, Interventional, and Prevention
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.
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.
2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.
This study's enrollment of 14 is below the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →London Health Sciences Centre OR Lawson Research Institute of St. Joseph's is the lead sponsor of 25 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 CVInsight System
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.
Early detection of hemodialysis-induced circulatory stress using the finometer
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.
Early detection of hemodialysis-induced circulatory stress using echocardiography
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.
This study is terminated, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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London Health Sciences Centre OR Lawson Research Institute of St. Joseph's