Evaluation of the Zynex Blood Volume Monitor in Healthy Adult Patients During a Blood Draw

Not Applicable

Completed

• Conditions: Blood Loss
• Interventions: Device: CM 1500

• Registration Number: NCT01846195
• Lead Sponsor: Zynex Monitoring Solutions

Brief Summary

Non-invasive monitoring to measure changes in blood volume.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-06
• Study First Submitted: 2013-03-13
• Primary Completion: 2013-03-20
• Study Completion: 2013-03-20
• Study First Submitted QC: 2013-04-30
• Study First Posted: 2013-05-03
• Results First Submitted: 2022-08-03
• Status Verified: 2022-10
• Results First Submitted QC: 2022-10-13
• Last Update Submitted: 2022-10-13
• Results First Posted: 2022-11-09
• Last Update Posted: 2022-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Healthy volunteers
• Between 18-35 years of age
• Weight between 130-200 pounds

Exclusion Criteria

• Known cardiac disease
• Recent caffeine intake
• Tobacco use in the (4) hours prior to screening
• Infection
• Pregnancy
• Hemoglobin <13.5 g/dl

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
blood draw	CM 1500	CM 1500 with blood draw
no blood draw	CM 1500	CM 1500 with no blood draw

Primary Outcome Measures

Name	Time	Method
Detect by Non-invasive Monitoring a Change in Blood Volume During a Whole Blood Draw	At study completion (completion of blood draw)	Detection by non-invasive monitoring a change in blood volume (yes or no) during a whole blood draw

Trial Locations

Locations (1)

Premier Research Group; 🇺🇸 Salt Lake City, Utah, United States