Desaturation Validation of INVSENSOR00039

Study Overview
=================
Brief Summary
-----------------
This study is designed to compare the accuracy of a noninvasive measurement of oxygen saturation compared to reference values obtained by a laboratory blood gas analyzer. Arterial blood samples will be collected from healthy adult subjects while undergoing a desaturation procedure wherein the concentration of oxygen inhaled is slowly reduced. The subject will then be returned to breathing room air.

Official Title
-----------------
Desaturation Validation of INVSENSOR00039

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Device: INVSENSOR00039


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Subject is 18-50 years of age. 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. Baseline heart rate ≥ 45 bpm and ≤ 85 bpm. Carbon monoxide (CO value) ≤ 2.0% fraction of carboxyhemoglobin (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. Blood pressure: Systolic Blood Pressure ≤ 140 mmHg and ≥ 90 mmHg, Diastolic Blood Pressure ≤ 90 mmHg and ≥ 50 mmHg, and if blood pressure is lower than 100/60 subject passes an orthostatic blood pressure test. Subject is able to read and communicate in English and understands the study and risks involved. Exclusion Criteria (* = per physician discretion) Subject is pregnant. Subject has a Body Mass Index (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 blood draw, or has a fear of blood draws. Subject smokes one pack of cigarettes or more in one week, and/or the equivalent of e- cigarette liquid, and smokers are not being recruited as indicated in the Case Study Report Form (CSRF). Subject has open wounds, inflamed tattoos or piercings, and/or any visible healing wounds that a medical professional renders them at an increased risk for participation.* Subject has known drug or alcohol abuse and/or use of recreational drugs. Subject experiences frequent or severe headaches and/or migraine headaches, migraine auras, altitude sickness, and/or headaches accompanied by visual changes or sensitivity to light or sound. Subject has experienced a concussion or head injury with loss of consciousness within the last 12 months. Subject has any history of a stroke, myocardial infarction, seizures or heart attack. Subject has a chronic bleeding disorder (i.e. hemophilia). Subject who has taken anticoagulant medication within the last 30 days (excluding nonsteroidal anti-inflammatory drugs (NSAIDS)). Subject has donated blood within the past 4 weeks. Subject has Wolff-Parkinson-White Syndrome or Stokes-Adams Syndrome. Subject has any symptomatic cardiac dysrhythmia (i.e. atrial fibrillation) and has not received clearance by their physician to participate. Subject has a known neurological and/or psychiatric disorder (i.e. schizophrenia, bipolar disorder, Multiple Sclerosis, Huntington's Disease) that interferes with the subject's level of consciousness. Subject has taken opioid pain medication 24 hours before the 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 syndrome. Subject has had invasive surgery within the past year- including but not limited to major dental surgery*, appendix*, plastic surgery*. Subject has had invasive surgery within the past year- including but not limited to gallbladder, major fracture repairs (involving plates/ screws), jaw surgery, urinary tract surgery, major ears, nose, and throat (ENT) surgery, joint replacement or gynecological surgeries, heart surgery or thoracic surgery. Subject has symptoms of congestion, head cold, flu or other illnesses. Subject experiences claustrophobia 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 any cancer or history of cancer (not including skin cancer).* Subject has chronic unresolved asthma, lung disease (including chronic obstructive pulmonary disease (COPD)) 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, tennis) 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. Subject has any medical condition which in the judgment of the investigator and/or medical staff, renders them ineligible for participation in this study or subject is deemed ineligible by the discretion of the investigator/study staff.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INVSENSOR00039<br>All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00039 sensor. | Device: INVSENSOR00039<br>* Noninvasive pulse oximeter sensor<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen Saturation (SpO2) Accuracy of Sensor | Performance of the sensors will be determined by comparing the noninvasive oxygen saturation measurement (SpO2) of the pulse oximeter sensors to the arterial oxygen saturation (SaO2) value obtained from a reference blood sample and calculating the Accuracy root square mean (ARMS) value. | 1-5 hours |