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Completed

NCT Number: NCT05980013

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

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.

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Key information

Conditions

Fluid Loss Blood Loss Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

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 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

Treatment and study plan

Whole blood donation supine

Device

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

Whole blood donation reclined

Device

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

Primary outcomes

  1. Impact of Subject Positioning on Percent Change of Heart Rate (HR) 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 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).

Sponsors and collaborators

Lead sponsor

Zynex Monitoring Solutions

Industry

Registry information

Official study 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)

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 7, 2023
Registry last updated
May 2, 2025

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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