Evaluation of Non-Invasive Continuous vs Intermittent BloodPressure Monitors in Maintenance Dialysis (BP Dialysis)

Sponsor

The Rogosin Institute (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05540457

Collaborator

Outset Medical (Industry), CareTaker Medical LLC (Industry)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Prospective, single center, open label, non-randomized, post-market study of the Tablo Hemodialysis System and VitalStream Monitor in participants with End-Stage KidneyDisease undergoing In-Center Hemodialysis.

Condition or Disease	Intervention/Treatment	Phase
End Stage Renal Disease End Stage Renal Disease on Dialysis Dialysis Hypotension Dialysis Induced Hypertension	Device: Intermittent Non-InvasiveBlood Pressure Monitor	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Evaluation of Non-Invasive Continuous vs Intermittent BloodPressure Monitors in Maintenance Dialysis

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Non-Invasive Blood Pressure (NIPB)Monitors NIPB Tablo Brachial Cuff (Intermittent): Will be placed contralateral to the access arm. Blood pressure measurements will be collected pre-dialysis, every 30minutes during dialysis, and post-dialysis. VitalStream Monitor (Continuous):A cuff will be applied to the middlefinger ipsilateral to the accessarm. Blood pressuremeasurements will be collectedpre-dialysis, continuously duringdialysis, and post-dialysis.	Device: Intermittent Non-InvasiveBlood Pressure Monitor Brachial cuff integrated with theTablo Hemodialysis System. Cuffwill be placed contralateral to theaccess arm, with measurementscollected pre-dialysis, every 30minutes during dialysis, and post-dialysis. Device: Continuous Non-InvasiveBlood Pressure Monitor VitalStream Monitor. Finger cuffwill be placed ipsilateral to theaccess arm, with measurementscollected pre-dialysis,continuously during dialysis, andpost-dialysis.

Arm

Intervention/Treatment

Experimental: Non-Invasive Blood Pressure (NIPB)Monitors

NIPB Tablo Brachial Cuff (Intermittent): Will be placed contralateral to the access arm. Blood pressure measurements will be collected pre-dialysis, every 30minutes during dialysis, and post-dialysis. VitalStream Monitor (Continuous):A cuff will be applied to the middlefinger ipsilateral to the accessarm. Blood pressuremeasurements will be collectedpre-dialysis, continuously duringdialysis, and post-dialysis.

Device: Intermittent Non-InvasiveBlood Pressure Monitor

Brachial cuff integrated with theTablo Hemodialysis System. Cuffwill be placed contralateral to theaccess arm, with measurementscollected pre-dialysis, every 30minutes during dialysis, and post-dialysis. Device: Continuous Non-InvasiveBlood Pressure Monitor VitalStream Monitor. Finger cuffwill be placed ipsilateral to theaccess arm, with measurementscollected pre-dialysis,continuously during dialysis, andpost-dialysis.

Outcome Measures

Primary Outcome Measures

Non-invasive Blood Pressure Monitor (NIPB) Measurements [7 days from start of participation]
Correlation of BP measurements (e.g., systolic, diastolic, mean arterial,and pulse pressures) between NIPB monitors.

Secondary Outcome Measures

Intradialytic Blood Pressure Events [7 days from start of participation]
Summary of observed intradialytic BP events (hypertensive andhypotensive)
Participant Preference for the Non-invasive Blood Pressure Monitor (NIPB) [7 days from start of participation]
Participant Preference Questionnaire (PPQ)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Participant is at least 18 years of age and has provided informed consent and has signed a Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliant authorization statement.
Participant weighs ≥ 34kg.
Participant has end stage kidney disease (ESKD) adequately treated by maintenance dialysis.

Exclusion Criteria:

Participant has lack of perfusion of the digitalarteries and arterioles in the lower arm and hand.
The Non-Invasive Blood Pressure (NIPB) monitorcuffs (finger and/or brachial) are unable to becorrectly sized to the participant.