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

The Rogosin Institute10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

End Stage Renal Disease End Stage Renal Disease on Dialysis Dialysis Hypotension Dialysis Induced Hypertension

Interventions

Intermittent Non-InvasiveBlood Pressure MonitorDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

The Rogosin Institute

New York, New York, United States

Outcomes

Primary Outcomes

Non-invasive Blood Pressure Monitor (NIPB) Measurements

Correlation of BP measurements (e.g., systolic, diastolic, mean arterial,and pulse pressures) between NIPB monitors.

Time frame: 7 days from start of participation

Secondary Outcomes

Intradialytic Blood Pressure Events

Summary of observed intradialytic BP events (hypertensive andhypotensive)

Time frame: 7 days from start of participation

Participant Preference for the Non-invasive Blood Pressure Monitor (NIPB)

Participant Preference Questionnaire (PPQ)

Time frame: 7 days from start of participation

Data from ClinicalTrials.gov

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