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

Primary Purpose

Fluid Loss, Blood Loss

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Whole blood donation supine

Whole blood donation reclined

About this trial

This is an interventional diagnostic trial for Fluid Loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

SunCoast Blood CentersRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Supine Donation Position

Reclined Donation Position

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05980013

First Posted

July 26, 2023

Last Updated

September 12, 2023

Sponsor

Zynex Monitoring Solutions

1. Study Identification

Unique Protocol Identification Number

NCT05980013

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 28, 2023 (Actual)

Primary Completion Date

December 22, 2023 (Anticipated)

Study Completion Date

January 22, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zynex Monitoring Solutions

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fluid Loss, Blood Loss

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Supine Donation Position

Arm Type

Experimental

Arm Title

Reclined Donation Position

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Whole blood donation supine

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Whole blood donation reclined

Intervention Description

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

Primary Outcome Measure Information:

Title

Impact of subject positioning on percent change of physiological parameters during minor blood loss

Description

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.

Time Frame

At completion of blood draw

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kristin Andrud, PhD

Phone

(800) 495-6670

Ext

3457

kandrud@zynex.com

Facility Information:

Facility Name

SunCoast Blood Centers

City

Bradenton

State/Province

Florida

ZIP/Postal Code

34211

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shelley Harkey

Phone

941-954-1600

Ext

10141

sharkey@suncoastblood.org

First Name & Middle Initial & Last Name & Degree

Debra Smith, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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