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 |
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.
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
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