CompletedNot Applicable

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

United States120 participantsStarted 2023-08-28

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

Impact of Subject Positioning on Percent Change of Heart Rate (HR) After Minor Blood Loss (e.g., 500mL)

Timeframe: Recovery period following donation (10 minutes)

Trial details

NCT IDNCT05980013

SponsorZynex Monitoring Solutions

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-04-10

Results submitted2025-04-08

View on ClinicalTrials.gov More Fluid Loss trials