Evaluation of Physiological Variables and Detection of Blood Loss in Healthy Adults With Different Subject Positioning by the Zynex Cardiac Monitor, Model 1500 (CM-1500)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Fluid Loss
- Sponsor
- Zynex Monitoring Solutions
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Impact of Subject Positioning on Percent Change of Heart Rate (HR) After Minor Blood Loss (e.g., 500mL)
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Impact of Subject Positioning on Percent Change of Heart Rate (HR) After Minor Blood Loss (e.g., 500mL)
Time Frame: Recovery period following donation (10 minutes)
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).