Clinical Equivalence of Masimo INVSENSOR00061 to RD SET Neo

NCT ID: NCT05674136

Last Updated: 2024-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-18
• Study Completion Date: 2022-12-07

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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Test Subject

All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00061 sensor

Group Type: EXPERIMENTAL

INVSENSOR00061

Intervention Type: DEVICE

Noninvasive pulse oximeter sensor

Interventions

INVSENSOR00061

Noninvasive pulse oximeter sensor

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Masimo Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Masimo Corporation

Irvine, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CIP-1056

Identifier Type: -

Identifier Source: org_study_id