Clinical Evaluation of the CM-1500 During Apheresis Blood Donation

Zynex Monitoring Solutions77 enrolled

Overview

The study is a prospective, single-arm, non-randomized, non-blinded, non-controlled, non-significant risk, single center study enrolling up to 200 healthy adult subjects consented to undergo an apheresis donation procedure. Subjects will be connected to the Zynex Cardiac Monitor, Model 1500 (CM-1500) to characterize changes in the relative index during an apheresis donation procedure.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Fluid Loss

Interventions

CM-1500DEVICE

The CM-1500 is a U.S. FDA cleared non-invasive monitoring device that simultaneously monitors five (5) parameters of a patient's body. A combination of these parameters is represented by a single number known as the Relative Index value.

CM-1600DEVICE

The CM-1500 is a U.S. FDA cleared non-invasive monitoring device that simultaneously monitors Bioelectrical Impedance, Photoplethysmography (PPG) Amplitude, ECG Amplitude and Skin Temperature. A combination of these parameters is represented by a single number known as the Relative Index value.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Ability to provide written informed consent * Ability and willingness to comply with the study procedures and duration requirements * 18 years of age or older * Consented to undergo an apheresis procedure with an automated blood component device Exclusion Criteria: * Females who are pregnant or breastfeeding * Undergone an amputation of the left upper extremity * Diagnosed with dextrocardia * Subjects who have a pacemaker

Locations (1)

Vitalant Blood Donation

Denver, Colorado, United States

Outcomes

Primary Outcomes

Characterize Changes in the Relative Index During an Apheresis Procedure

The objective of the study is to characterize changes in the Relative Index (RI) as a representation of its associated parameters during apheresis. This was measured by averaging the RI values after the procedure. Changes in parameters from their baseline can be used as an indicator of potential change in fluid status. This change may be reflected in the RI since it is a summated value (weighted summation of percent change) combining the changes of the parameters into a single value. In the case of fluid loss such as apheresis the RI value may decrease as a result of changes in the parameters which can change in response to fluid status change. The RI is a unitless value with no set min. or max. Within the context of this trial trying to evaluate the RI, a decrease from 100 was considered a good outcome. However, in clinical use, the RI should not be used as an indicator of patient status, instead it could be used to monitor trending of patient parameters relative to their baseline.

Time frame: Duration of apheresis procedure (e.g., 2 - 3hrs)

Data from ClinicalTrials.gov

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