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

Not Applicable

Completed

• Conditions: Fluid Loss; Blood Loss
• Interventions: Device: Whole blood donation supine; Device: Whole blood donation reclined

• Registration Number: NCT05980013
• Lead Sponsor: Zynex Monitoring Solutions

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-26
• Study First Submitted QC: 2023-08-03
• Study First Posted: 2023-08-07
• Study Start: 2023-08-28
• Primary Completion: 2024-04-10
• Study Completion: 2024-04-10
• Status Verified: 2025-04
• Results First Submitted: 2025-04-08
• Results First Submitted QC: 2025-04-30
• Last Update Submitted: 2025-04-30
• Results First Posted: 2025-05-02
• Last Update Posted: 2025-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supine Donation Position	Whole blood donation supine	-
Reclined Donation Position	Whole blood donation reclined	-

Primary Outcome Measures

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

Trial Locations

Locations (2)

SunCoast Blood Centers; 🇺🇸 Bradenton, Florida, United States

Vitalant Research Institute; 🇺🇸 Denver, Colorado, United States