Status:
COMPLETED
Desaturation Validation of INVSENSOR00038
Lead Sponsor:
Masimo Corporation
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
This study is designed to evaluate the trending accuracy of a noninvasive regional oximetry measurement of somatic oxygen saturation. One investigational sensor (INVSENSOR00038) will be placed on the ...
Eligibility Criteria
Inclusion
- Subject is between 18 and 50 years of age.
- Subject weighs a minimum of 110 lbs and no more than 250 lbs unless subject is over 6 feet tall.
- Must have a hemoglobin value greater than or equal to 11 g/dL.
- Baseline heart rate ≥ 45 bpm and ≤ 85 bpm.
- Blood Pressure (Systolic BP \< 140 mmHg and Diastolic BP \< 90 mmHg).
- Carbon Monoxide (CO) value less than or equal to 2.0% fractional 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.
- Subject is able to read and communicate in English and understands the study and risks involved.
Exclusion
- 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, or has a fear of blood draws.
- Subject has open wounds, inflamed tattoos or piercings and/or visible healing wounds that a medical professional renders them at an increased risk for participation.\*
- 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 known drug or alcohol abuse and/or uses 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 known neurological and/or psychiatric disorder (i.e. schizophrenia, bipolar disorder, Multiple Sclerosis, Huntington's disease) that interferes with the subjects' level of consciousness.
- Subject has any cardiac dysrhythmia(s) (i.e. atrial fibrillation) and has not received clearance by their physician to participate.
- Subject has Wolff-Parkinson-White Syndrome or Stokes-Adams Syndrome.
- Subject 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 taken opioid pain medication within 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 gallbladder, major fracture repairs (involving plates/ screws), jaw surgery, urinary tract 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 is claustrophobic and/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 a heart condition, 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 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/study staff).
Key Trial Info
Start Date :
July 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 19 2019
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04017611
Start Date
July 8 2019
End Date
July 19 2019
Last Update
October 20 2020
Active Locations (1)
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1
Masimo Corporation
Irvine, California, United States, 92618