Trial Outcomes & Findings for Evaluation of the Zynex Blood Volume Monitor in Healthy Adult Patients During a Blood Draw (NCT NCT01846195)

Results Overview

Detection by non-invasive monitoring a change in blood volume (yes or no) during a whole blood draw

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

At study completion (completion of blood draw)

Results posted on

2022-11-09

Participant milestones
Measure	no Blood Draw CM 1500 with no blood draw CM 1500	Blood Draw CM 1500 with blood draw CM 1500
Overall Study STARTED	5	45
Overall Study COMPLETED	5	45
Overall Study NOT COMPLETED	0	0

Withdrawal data not reported

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

Baseline characteristics by cohort
Measure	no Blood Draw n=5 Participants CM 1500 with no blood draw CM 1500	Blood Draw n=45 Participants CM 1500 with blood draw CM 1500	Total n=50 Participants Total of all reporting groups
Age, Continuous	25.5 years n=5 Participants	25.9 years n=7 Participants	25.7 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	21 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	24 Participants n=7 Participants	27 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	45 participants n=7 Participants	50 participants n=5 Participants
Height	69.2 inches n=5 Participants	67.9 inches n=7 Participants	68.6 inches n=5 Participants
Weight	162.3 pounds n=5 Participants	158.4 pounds n=7 Participants	160.4 pounds n=5 Participants

Timeframe: At study completion (completion of blood draw)

Population: Number of subjects for which blood loss was detected.

Detection by non-invasive monitoring a change in blood volume (yes or no) during a whole blood draw

Outcome measures
Measure	no Blood Draw n=5 Participants CM 1500 with no blood draw CM 1500	Blood Draw n=45 Participants CM 1500 with blood draw CM 1500
Detect by Non-invasive Monitoring a Change in Blood Volume During a Whole Blood Draw	0 participants	45 participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	no Blood Draw n=5 participants at risk CM 1500 with no blood draw CM 1500	Blood Draw n=45 participants at risk CM 1500 with blood draw CM 1500
General disorders Vasovagal Reaction to Blood Draw	0.00% 0/5 • Adverse event data was collected through the completion of the study. Adverse events per subject may have occurred during the blood draw or within 24 hours following with any potential reaction to electrode adhesive.	11.1% 5/45 • Adverse event data was collected through the completion of the study. Adverse events per subject may have occurred during the blood draw or within 24 hours following with any potential reaction to electrode adhesive.

Zynex Monitoring Solutions

Phone: 1-800-495-6670