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

NCT05980013 | Completed Results FDA Device

• 1 other identifier: ZMS-1500-Pa2023
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Fluid Loss; Blood Loss

Outcome Measures

Primary Outcomes (1)

• 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).

  Recovery period following donation (10 minutes)

Study Arms (2)

Supine Donation Position

EXPERIMENTAL

Device: Whole blood donation supine

Reclined Donation Position

EXPERIMENTAL

Device: Whole blood donation reclined

Interventions

Whole blood donation supine DEVICE

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

Supine Donation Position

Whole blood donation reclined DEVICE

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

Reclined Donation Position

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to provide written informed consent
• Ability and willingness to comply with the study procedures and duration requirements
• years of age or older
• Consented and eligible to undergo a single unit whole blood donation

You may not qualify if:

• 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

Sponsors & Collaborators

• Zynex Monitoring Solutions: lead

Study Sites (2)

Vitalant Research Institute

Denver, Colorado, 80230, United States

Location

SunCoast Blood Centers

Bradenton, Florida, 34211, United States

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: ZMS Clinical
• Organization: Zynex Monitoring Solutions

clinical@zynex.com

888-386-4185

Study Officials

• Debra Smith, MD; PhD

  SunCoast Blood Centers

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 7, 2023
• Study Start: August 28, 2023
• Primary Completion: April 10, 2024
• Study Completion: April 10, 2024
• Last Updated: May 2, 2025
• Results First Posted: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)