Healthy
Conditions
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.
Interventions
DEVICEINVSENSOR00061
Noninvasive pulse oximeter sensor
Sponsors
Masimo Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Masimo INVSENSOR00061 All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo INVSENSOR00061 sensor
Masimo INVSENSOR00061: Noninvasive pulse oximeter sensor | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Masimo INVSENSOR00061 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Region of Enrollment United States | 30 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 62 |
| other Total, other adverse events | 6 / 62 |
| serious Total, serious adverse events | 0 / 62 |
Outcome results
Primary
SpO2 Accuracy
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
Time frame: 1-3 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test Subject | SpO2 Accuracy | 1.24 % of oxygen saturated hemoglobin |