Hemodilution Validation of INVSENSOR00026



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 50
Updated:4/3/2019
Start Date:September 4, 2018
End Date:February 4, 2019

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In this study, the concentration of hemoglobin within the subject's blood will be reduced in
a controlled manner by administering fluids intravenously. The accuracy of a noninvasive
hemoglobin sensor will be assessed by comparison to hemoglobin measurements from a laboratory
analyzer.


Inclusion Criteria:

- Subject weighs a minimum of 110 lbs and no more than 250 lbs unless subject is over 6
feet tall.

- Hemoglobin value is greater than or equal to 11 g/dL at time of screening

- Baseline heart rate ≥ 45 bpm and ≤ 85 bpm.

- CO value ≤ 2.0% FCOHb

- Subject has a physical status of ASA I or II (American Society of Anesthesiology Class
I; Healthy subjects without any systemic disease at all. American Society of
Anesthesiology Class II; subjects with mild systemic disease) as it applies to the
systemic disease portion of the classification.

- Systolic Blood Pressure ≤ 140 mmHg and Diastolic Blood Pressure ≤ 90 mmHg.

- Subject is able to read and communicate in English and understands the study and risks
involved.

Exclusion Criteria:

- Subject is pregnant

- Subject smokes (including e-cigarette use)

- Subject has a BMI > 35 and has been classified as morbidly obese or at an increased
risk for participation by a medical professional.

- Subject has a history of fainting (vasovagal), blacking out or losing consciousness
during or after a blood draw.

- Subject has open wounds, inflamed tattoos or piercings, or any visible healing wounds.

- Subject has known drug or alcohol abuse or uses recreational drugs.

- Subject has experienced a head injury with loss of consciousness within the last year.

- Subject has taken anticoagulant medication within the last 30 days.

- Subject has any chronic bleeding disorders (i.e. hemophilia).

- Subject has any history of a stroke, myocardial infarction, heart attack, or seizures.

- Subject has any cancer or history of cancer (not including skin cancer).

- Subject has a chronic neurological disease (i.e. multiple sclerosis, Huntington's
disease).

- Subject has any cardiac dysrhythmias (i.e. atrial fibrillation) and has not received
clearance from their physician.

- Subject has known neurological and/or psychiatric disorder (i.e. schizophrenia,
bipolar disorder) that interferes with the subject's level of consciousness.

- Subject has Wolff-Parkinson-White Syndrome or Stokes-Adams Syndrome

- Subject has any medical condition which in the judgment of the investigator and/or
medical staff, renders them ineligible for participation in this study (Discretion of
investigator).

- Subject has taken opioid pain medication within 24 hours of start of study.

- Subject has any type of infectious disease (i.e. Hepatitis, HIV, Tuberculosis, Flu,
Malaria, Measles, etc.).

- Subject is taking medications known to treat any type of infectious disease.

- Subject has either signs or history of peripheral ischemia or carpal tunnel.

- Subject has had invasive surgery within the past year- including but not limited to
major dental surgery, gallbladder, heart, appendix, major fracture repairs (involving
plates/ screws), jaw surgery, Urinary tract surgery, plastic surgery, major ENT
surgery, joint replacement or gynecological surgeries, heart surgery or thoracic
surgery.

- Subject has symptoms of congestion, head colds, flu, or other illnesses

- Subject has donated blood within the last 2 weeks.

- Subject is claustrophobic or has generalized anxiety disorder.

- Subject has been in severe car accident(s) or a similar type of accident(s) requiring
hospitalization within the last 12 months.

- Subject has had a concussion within the last 12 months.

- Subject has chronic unresolved asthma, lung disease or respiratory disease.

- Subject is allergic to lidocaine, latex, adhesives, or plastic.

- Subject has heart conditions, insulin-dependent diabetes or uncontrolled hypertension.

- Subject has delivered vaginally, has had a pregnancy terminated, a miscarriage with
hospitalization, or had a C-section within the last 6 months.

- Subject intends on participating in any heavy lifting, repetitive movement of their
wrist (including riding a motorcycle) or exercise (working out, riding a bike, riding
a skate board etc.), or any activity that will put additional stress on the wrist
within 24 hours following a study that involves an arterial line.

- Discretion of investigator/study staff
We found this trial at
1
site
Irvine, California 92618
?
mi
from
Irvine, CA
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