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OpenTrials
Completed

NCT Number: NCT05463198

Evaluation of Physiological Variables and Detection of Blood Loss Using the Zynex Fluid Monitoring System, Model CM-1600

The study is a prospective, non-randomized, non-blinded, non-significant risk, multi-center study enrolling up to 500 healthy adult subjects consented to undergo a whole blood donation procedure. The study will involve enrolling subjects that will undergo blood donation wearing the study device (CM-1600 Device) and capture study-required physiological parameters pre-, during, and post-donation.

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Key information

Conditions

Fluid Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vitalant Research Institute, Denver, Colorado, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ability to provide written 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

Treatment and study plan

CM-1600

Device

Subjects undergoing blood donation will be connected to the CM-1600 device.

Primary outcomes

  1. Change in the Relative Index (RI) After Minor Blood Loss (e.g., 500mL)

    Time frame: Recovery period following donation (10 minutes)

    The objective of this study is to determine if manual blood loss of up to 500mL of blood can be identified using the non-invasive Zynex CM-1600. This will be measured by determining the percent change in Relative Index (RI) before and after the Blood Draw. The RI is an investigational value which utilizes proprietary algorithms to combine the changes of multiple measured parameters (utilizing a weighted summation of percent change values) which are indicative of relative changes in fluid volume in adult patients into a single value. The RI is a unitless value with no set minimum or maximum, where 100 is a patient's baseline. Based on the nature of the RI itself, a direct interpretation of a positive or negative outcome cannot be derived from the absolute value, instead it could be used to monitor trending of a patient's parameters relative to their baseline.

Sponsors and collaborators

Lead sponsor

Zynex Monitoring Solutions

Industry

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 18, 2022
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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