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

The Rogosin Institute

Status: Completed

Conditions: Dialysis Induced Hypertension; End Stage Renal Disease on Dialysis; End Stage Renal Disease; Dialysis Hypotension

Treatments: Device: Intermittent Non-InvasiveBlood Pressure Monitor

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05540457

2022-01

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Non-Invasive Blood Pressure (NIPB)Monitors

Experimental group

Description:

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.

Treatment:

Device: Intermittent Non-InvasiveBlood Pressure Monitor