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NCT05980013 Clinical Trial

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

Blood Loss Clinical Trial

Official title:
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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05980013
Other study ID # ZMS-1500-Pa2023
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 28, 2023
Est. completion date April 10, 2024

Study information
Verified date May 2024
Source Zynex Monitoring Solutions
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date April 10, 2024
Est. primary completion date April 10, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Whole blood donation supine
Subjects will undergo a 1-unit whole blood donation in a supine position
• Whole blood donation reclined
Subjects will undergo a 1-unit whole blood donation in a reclined position

Locations
Country Name City State
United States SunCoast Blood Centers Bradenton Florida
United States Vitalant Research Institute Denver Colorado

Sponsors (1)
Lead Sponsor Collaborator
Zynex Monitoring Solutions

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Impact of subject positioning on percent change of physiological parameters during minor blood loss Percent change in heart rate, forearm skin temperature, bioelectrical impedance, ECG amplitude and PPG amplitude before and after blood draw in either a reclined or supine position. At completion of blood draw
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