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

Zynex Monitoring Solutions

Status: Completed

Conditions: Fluid Loss; Blood Loss

Treatments: Device: Whole blood donation reclined; Device: Whole blood donation supine

Study type: Interventional

Funder types: Industry

Identifiers

NCT05980013

ZMS-1500-Pa2023

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Supine Donation Position

Experimental group

Treatment:

Device: Whole blood donation supine

Reclined Donation Position

Experimental group

Treatment:

Device: Whole blood donation reclined