Clinical Equivalence of Masimo INVSENSOR00061 to RD SET Neo
Not Applicable
Completed
- Conditions
- Healthy
- Interventions
- Device: INVSENSOR00061
- Registration Number
- NCT05674136
- Lead Sponsor
- Masimo Corporation
- Brief Summary
This study is designed to compare the equivalence of the Masimo INVSENSOR00061 to RD SET Neo for SpO2 and performance of PR and RRp as the subjects undergo a controlled desaturation protocol. This type of study design is required to evaluate the performance of pulse oximeters based upon the ISO 80601-2-61 standard which is also adopted and referenced by the FDA.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
Inclusion Criteria
- Subject is 18 to 50 years of age.
- Subject weighs a minimum of 110 lbs.
- Hemoglobin value ≥ 11 g/dL.
- Baseline heart rate ≥ 45 bpm and ≤ 85 bpm.
- 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.
- CO value ≤ 3.0% FCOHb.
- Subject is able to read and communicate in English and understands the study and the risks involved
Exclusion Criteria
- Subject is pregnant.
- Subject has a BMI > 35.
- Subject is wearing nail polish that cannot be removed, gel nails, and/or acrylic nails that can interfere with study device's placement is deemed ineligible at the discretion of investigator/study staff. *
- 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 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.
(*)Physician's discretion.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Test Subject INVSENSOR00061 All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00061 sensor
- Primary Outcome Measures
Name Time Method SpO2 Accuracy 1-3 hours SpO2 accuracy was determined by calculating the root mean-squared (rms) difference between the measured values (SpO2i) to the reference values (SpO2ref_i) in accordance with ISO-80601-2-61. Arms= √(∑(i=1 to n) ((SpO2_i-SpO2ref_i )\^2 ))/n
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Masimo Corporation
🇺🇸Irvine, California, United States