Evaluation of Physiological Variables and Detection of Blood Loss in Healthy Adults With Different Subject Positioning by the CM-1500

Zynex Monitoring Solutions120 enrolled

Overview

The study is a prospective, non-randomized, non-blinded, non-significant risk study enrolling up to 60 healthy adult subjects consented to undergo a 1-unit whole blood draw procedure. Subjects will wear the study device (CM-1500) while positioned in either a supine or reclined position during the blood draw and study-required physiological parameters will be captured pre-, during, and post-donation.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

120

Conditions

Fluid Loss Blood Loss

Interventions

Whole blood donation supineDEVICE

Subjects will undergo a 1-unit whole blood donation in a supine position

Whole blood donation reclinedDEVICE

Subjects will undergo a 1-unit whole blood donation in a reclined position

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 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 (2)

Vitalant Research Institute

Denver, Colorado, United States

SunCoast Blood Centers

Bradenton, Florida, United States

Outcomes

Primary Outcomes

Impact of Subject Positioning on Percent Change of Heart Rate (HR) 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 affects heart rate. This will be measured by determining the percent change in HR before and after the Blood Draw. The percent change will be calculated separately for each Arm (reclined, supine). Based on previous studies, a positive outcome would be indicated by an increase in HR (i.e., positive percent change).

Time frame: Recovery period following donation (10 minutes)

Data from ClinicalTrials.gov

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