Blood Loss, Healthy
Conditions
Keywords
blood, loss, healthy, volume, To evaluate the ability of the Zynex BVM to non-invasively detect blood loss in healthy subjects during a blood draw.
Brief summary
Zynex's blood volume monitor (BVM) is a non-invasive monitoring device to monitor blood volume and blood loss of a patient during surgery, post operatively and/or in recovery. This monitoring device will identify baseline blood volume and relative changes in blood volume using a specific algorithm to compare and review data already monitored during surgery, displaying blood volume and blood loss in real-time.
Interventions
DEVICECM-1500
Blood Volume Monitor
Sponsors
Zynex Monitoring Solutions
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Written informed consent * Male, 18-65 years of age * Subject is suitable for a blood draw of a pint of blood * Weighs at least 110 pounds
Exclusion criteria
* Subject has a heart condition that may interfere with the Zynex CM-1500 * Subject has unstable or untreated heart disease * Subject has been diagnosed with chronic fatigue syndrome * Subject is taking coumadin (warfarin), heparin, or other prescription blood thinners for at least 7 days prior to blood draw * Subject donated blood within 8 weeks prior to blood draw * Subject has high or low blood pressure on the day of blood draw * Subject hemoglobin \< 12.5 g/dL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Detect change in blood volume during blood draw | 15-30 minutes |
Secondary
| Measure | Time frame |
|---|---|
| Detect insidious bleeding | 15-30 minutes |
Countries
United States
Outcome results
None listed