Evaluation of Non-Invasive Continuous vs Intermittent BloodPressure Monitors in Maintenance Dialysis (BP Dialysis)
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.
Arms and Interventions
|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.
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)
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.
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.
Contacts and Locations
|1||The Rogosin Institute||New York||New York||United States||10019|
Sponsors and Collaborators
- The Rogosin Institute
- Outset Medical
- CareTaker Medical LLC
Study Documents (Full-Text)None provided.