Status:
COMPLETED
Clinical Performance of Masimo INVSENSOR00040
Lead Sponsor:
Masimo Corporation
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
This study is designed to compare the accuracy of a noninvasive measurement of oxygen saturation and pulse rate to reference values obtained by a laboratory blood gas analyzer and a standard of care E...
Eligibility Criteria
Inclusion
- Subject is 18 to 50 years of age.
- Subject weighs a minimum of 110 lbs.
- Subject has a hemoglobin value ≥ 11 g/dL.
- Subject's baseline heart rate is ≥ 45 bpm and ≤ 85 bpm.
- Subject's CO value is ≤ 3.0% FCOHb.
- Subject's blood pressure: Systolic BP ≤ 140 mmHg and ≥ 90 mmHg, Diastolic BP ≤ 90 mmHg and ≥ 50 mmHg, and if systolic BP is lower than 100 mmHg and/or diastolic BP is lower than 60 mmHg, subject passes an orthostatic blood pressure test.
- Subject is able to read and communicate in English and understands the study and the risks involved.
Exclusion
- Subject whose skin is not intact and/or has tattoos in the area of device placement (e.g., wrist).\*
- Subject is pregnant.
- Subject has a BMI \> 35.
- Subject has a history of fainting (vasovagal syncope), 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 has any visible healing wounds that a medical professional determines may place them at an increased risk for participation.\*
- Subject has known drug or alcohol abuse.
- Subject uses 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 past 12 months.
- Subject has any history of a stroke, myocardial infarction (heart attack), and/or seizures.
- Subject has any chronic bleeding disorder (e.g. hemophilia).
- Subject has taken anticoagulant medication within the past 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 (e.g. atrial fibrillation) and has not received clearance from their physician to participate.
- Subject has a known neurological and/or psychiatric disorder (e.g. 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 active signs and/or symptoms of infectious disease (e.g. 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, appendectomy, plastic surgery, jaw surgery, major ENT surgery, major abdominal and/or pelvic surgery, heart surgery, or thoracic surgery.\*
- Subject has symptoms of congestion, head cold, or other illnesses.
- Subject has been in a severe car accident(s) or a similar type of accident(s) requiring hospitalization within the past 12 months.
- Subject has any cancer or history of cancer (not including skin cancer).\*
- Subject has chronic unresolved asthma, lung disease (including COPD) and/or respiratory disease.
- Subject is allergic to lidocaine, chlorhexidine, 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 past 6 months.
- Subject intends on participating in any heavy lifting, repetitive movement of their wrist (including riding a motorcycle, tennis), exercise (working out, riding a bike, riding a skateboard, 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.
Key Trial Info
Start Date :
April 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 13 2023
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05332392
Start Date
April 14 2022
End Date
April 13 2023
Last Update
June 11 2024
Active Locations (1)
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1
Masimo Corporation
Irvine, California, United States, 92618