Evaluation of Physiological Variables and Detection of Blood Loss Using the Zynex Fluid Monitoring System, Model CM-1600

Zynex Monitoring Solutions351 enrolled

Overview

The study is a prospective, non-randomized, non-blinded, non-significant risk, multi-center study enrolling up to 500 healthy adult subjects consented to undergo a whole blood donation procedure. The study will involve enrolling subjects that will undergo blood donation wearing the study device (CM-1600 Device) and capture study-required physiological parameters pre-, during, and post-donation.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

351

Conditions

Fluid Loss

Interventions

CM-1600DEVICE

Subjects undergoing blood donation will be connected to the CM-1600 device.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Ability to provide written consent * Ability and willingness to comply with the study procedures and duration requirements * 18 years of age or older * Consented and eligible to undergo a single unit whole blood donation Exclusion Criteria: * Females who are pregnant or breastfeeding * Undergone an amputation of any upper extremity * Diagnosed with dextrocardia * Subjects who have a pacemaker * Subjects with body hair density which prevents adequate application of device electrodes

Locations (4)

Vitalant Research Institute

Denver, Colorado, United States

SunCoast Blood Centers

Bradenton, Florida, United States

ClinCept, LLC

Columbus, Georgia, United States

Blood Assurance

Chattanooga, Tennessee, United States

Outcomes

Primary Outcomes

Change in the Relative Index (RI) After Minor Blood Loss (e.g., 500mL)

The objective of this study is to determine if manual blood loss of up to 500mL of blood can be identified using the non-invasive Zynex CM-1600. This will be measured by determining the percent change in Relative Index (RI) before and after the Blood Draw. The RI is an investigational value which utilizes proprietary algorithms to combine the changes of multiple measured parameters (utilizing a weighted summation of percent change values) which are indicative of relative changes in fluid volume in adult patients into a single value. The RI is a unitless value with no set minimum or maximum, where 100 is a patient's baseline. Based on the nature of the RI itself, a direct interpretation of a positive or negative outcome cannot be derived from the absolute value, instead it could be used to monitor trending of a patient's parameters relative to their baseline.

Time frame: Recovery period following donation (10 minutes)

Data from ClinicalTrials.gov

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