N/A
N=20
Clinical Evaluation of the Zynex Monitoring System, Model CM-1600
Fluid Loss
Bottom Line
View on ClinicalTrials.gov: NCT05740644 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: CM-1600 Ability to Detect Minor Blood Loss — 8.0 Percent change in RI
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CM-1600 (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Zynex Monitoring Solutions
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY CM-1600 Ability to Detect Minor Blood Loss |
8.0 | — |
| PRIMARY CM-1600 Ability to Detect Saline Reinfusion |
10.2 | — |
Summary
This is a prospective, single-arm, non-randomized, non-controlled single-center study for the evaluation of the Zynex CM-1600 in 20 healthy adults undergoing a manual blood loss of up to 500mL followed by an infusion of 1 liter of normal saline.
Eligibility Criteria
Inclusion Criteria
- Participant must have the ability to understand the parameters of participation and provide written informed consent
- Male or female of any race
- Participant is adult 18 or older
- Participant must be willing and able to comply with study procedures and duration
- In the Principal Investigator's medical judgment, the participant is suitable for a blood draw of up to 500mL
- Participant must weigh at least 110 pounds
Exclusion Criteria
- Any upper extremity amputation
- Females who are pregnant, who are trying to get pregnant, or have a urine test positive for pregnancy on the day of the study
- Participant has a heart condition that may interfere with the Zynex CM-1600 (e.g., pacemakers, defibrillator, irregular heartbeat, dextrocardia, etc.)
- Participant has been diagnosed with chronic fatigue syndrome (also known as chronic fatigue, immune dysfunction syndrome, or myalgic encephalomyelitis)
- Participant requires equipment and/or devices that may interfere with the Zynex CM-1600 (e.g., life-sustaining equipment, other monitoring devices, insulin pumps, or other implanted devices)
- Participant is taking coumadin (warfarin), heparin, or other prescription blood thinners for 7 or more days prior to blood draw
- Participant donated blood within 8 weeks prior to the study blood draw
- Participant has high or low blood pressure on the day of blood draw (high blood pressure is defined as systolic > 180 mmHg or diastolic > 100 mmHg; low blood pressure is defined as systolic < 100 mmHg or diastolic < 60 mmHg)
- Participant has symptoms of an active infection or a temperature ≥ 100 °F
- Female with hemoglobin levels of less than 12.1g/dL or male with hemoglobin levels of less than 13.8g/dL
- Participants with self-reported heart or cardiovascular conditions such as:
- History of cardiovascular surgery
- History of chest pain (angina)
- Heart rhythms other than a normal sinus rhythm or respiratory sinus arrhythmia
- History heart attack/myocardial infarction
- Peripheral arterial disease
- Carotid artery disease
- Unexplained shortness of breath
- Congestive heart failure (CHF)
- History of stroke/transient ischemic attack
- Myocardial ischemia
- Cardiomyopathy
- Dextrocardia
- Participants with clotting disorders such as:
- Hemophilia
- History of blood clots
- History of bleeding problems
- Bruises easily
- Self-reported health conditions as identified in the Health Assessment Form including:
- Diabetes
- Uncontrolled thyroid disease
- Kidney disease / chronic renal impairment
- History of seizures (except childhood febrile seizures)
- Epilepsy
- History of unexplained syncope
- Recent history of frequent migraine headache within the last 2 months
- Recent head injury within the last 2 months
- History of cancer, with or without chemotherapy within the last 2 months
- Other known health conditions deemed unsuitable for participation by the PI when considered upon disclosure on health assessment form
Data sourced from ClinicalTrials.gov (NCT05740644). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.