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

• ClinicalTrials.gov Identifier: NCT03661229
• Recruitment Status: Terminated
• First Posted: September 7, 2018
• Last Update Posted: August 19, 2021
• Sponsor: Lawson Health Research Institute
• Collaborator: Intelomed, Inc.
• Information provided by (Responsible Party): Chris McIntyre, Lawson Health Research Institute

Tracking Information

• First Submitted Date: August 22, 2018
• First Posted Date: September 7, 2018
• Last Update Posted Date: August 19, 2021
• Actual Study Start Date: October 21, 2018
• Actual Primary Completion Date: October 8, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 4, 2018)

• Mobile CVInsight validation against the CVInsight contact device by recording pulse rate trends [ Time Frame: Through dialysis session, an average of 4 hours for two separate visits within the same week. ]
  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 [ Time Frame: Through dialysis session, an average of 4 hours for two separate visits within the same week. ]
  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 [ Time Frame: Through dialysis session, an average of 4 hours for two separate visits within the same week. ]
  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 [ Time Frame: Through dialysis session, an average of 4 hours for two separate visits within the same week. ]
  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 [ Time Frame: Through dialysis session, an average of 4 hours for two separate visits within the same week. ]
  Validation of the mobile CVInsight with the oxygen saturation variability (derived from the oximeter signal) from the CVInsight contact device

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 4, 2018)

• Early detection of hemodialysis-induced circulatory stress using the CVInsight System [ Time Frame: Through dialysis session, an average of 4 hours for two separate visits within the same week. ]
  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 [ Time Frame: Through dialysis session, an average of 4 hours for two separate visits within the same week. ]
  The secondary outcome will be assessment of the finometer on hemodialysis induced circulatory stress
• Early detection of hemodialysis-induced circulatory stress using echocardiography [ 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. ]
  The secondary outcome will be assessment of echocardiography on hemodialysis induced circulatory stress

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
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.

Masking: None (Open Label)
Primary Purpose: Prevention

• Condition: End-stage Renal Disease

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.

Study Arms

Experimental: CVInsight Monitoring

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

Intervention: Device: CVInsight Monitoring

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: August 15, 2021): 14
• Original Estimated Enrollment (submitted: September 4, 2018): 50
• Actual Study Completion Date: October 8, 2020
• Actual Primary Completion Date: October 8, 2020 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT03661229
• Other Study ID Numbers: 112553
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Chris McIntyre, Lawson Health Research Institute
• Original Responsible Party: Same as current
• Current Study Sponsor: Lawson Health Research Institute
• Original Study Sponsor: Same as current
• Collaborators: Intelomed, Inc.

Investigators

• Principal Investigator: Christopher McIntyre, MBBS DM; London Health Sciences Centre

• PRS Account: Lawson Health Research Institute
• Verification Date: August 2021