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

End-stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03661229
• Other study ID #: 112553
• Status: Terminated
• Phase: N/A
• Start date: October 21, 2018
• Est. completion date: October 8, 2020

Study information

• Verified date: August 2021
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: October 8, 2020
• Est. primary completion date: October 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients receiving conventional thrice weekly maintenance HD

• Age =18 years

• Able to provide informed consent

Exclusion Criteria:

• Not meeting inclusion criteria

Related Conditions & MeSH terms

• End-stage Renal Disease
• Kidney Failure, Chronic

Intervention

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.

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Intelomed, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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	Through dialysis session, an average of 4 hours for two separate visits within the same week.
Secondary	Early detection of hemodialysis-induced circulatory stress using the finometer	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.
Secondary	Early detection of hemodialysis-induced circulatory stress using echocardiography	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.