Clinical trial NCT05674136: Clinical Equivalence of Masimo INVSENSOR00061 to RD SET Neo
Official title: Clinical Equivalence of Masimo INVSENSOR00061 to RD SET Neo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2023-01-06
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: SpO2 Accuracy
timeFrame: 1-3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Masimo Corporation
state: California
Study officials:
References: