Status:
COMPLETED
Desaturation Validation of INVSENSOR00009
Lead Sponsor:
Masimo Corporation
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
This study is designed to measure the trending accuracy of a noninvasive measurement of cerebral oxygen saturation. One Large sensor (adult sensor) and one INVSENSOR00009 will be placed on the subject...
Eligibility Criteria
Inclusion
- 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% FCOHb (Fractional saturation of hemoglobin with Carbon monoxide)
- Subject has a physical status of American Society of Anesthesiology (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
- Subject is pregnant.
- Subject smokes (smoking includes 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 open wounds, inflamed tattoos or piercings, visible healing wounds.
- Subject experiences frequent or severe headaches and/or migraine headaches.
- Subject has known drug or alcohol abuse and/or use of recreational drugs.
- Subject has experienced a concussion or head injury with loss of consciousness within the last year.
- Subject has any chronic bleeding disorders (i.e. hemophilia).
- Subject has any history of a stroke, myocardial infarction, seizures or heart attack.
- 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 dysrhythmia(s) (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) that interferes with the subject's level of consciousness.
- 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 Wolff-Parkinson-White Syndrome or Stokes-Adams Syndrome.
- Subject who has taken anticoagulant medication within the last 30 days.
- Subject has taken opioid pain medication within 24 hours of start of study.
- Subject has either signs or history of peripheral ischemia.
- 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 ear nose and throat (ENT) surgery, joint replacement or gynecological surgeries, heart surgery or thoracic surgery.
- Subject has donated blood within the past 30 days.
- Subject has symptoms of congestion, head colds, 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 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 given vaginal delivery, had a pregnancy terminated, a miscarriage with hospitalization, or had a C-section within the last 6 months.
- Discretion of investigator/study staff.
Key Trial Info
Start Date :
December 18 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 16 2018
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03396835
Start Date
December 18 2017
End Date
January 16 2018
Last Update
August 28 2019
Active Locations (1)
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1
Masimo Clinical Lab
Irvine, California, United States, 92618