Clinical Equivalence of Masimo INVSENSOR00061 to RD SET Neo

NCT05674136 | Completed Results FDA Device

• 1 other identifier: CIP-1056
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

  1-3 hours

Study Arms (1)

Test Subject

EXPERIMENTAL

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

Device: INVSENSOR00061

Interventions

INVSENSOR00061 DEVICE

Noninvasive pulse oximeter sensor

Test Subject

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Masimo Corporation: lead

Study Sites (1)

Masimo Corporation

Irvine, California, 92618, United States

Location

Results Point of Contact

• Title: Ahmed Alghazi
• Organization: Masimo Corporation

studies@masimo.com

949-297-7000

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: January 6, 2023
• Study Start: November 18, 2022
• Primary Completion: December 7, 2022
• Study Completion: December 7, 2022
• Last Updated: June 13, 2024
• Results First Posted: June 13, 2024

Record last verified: 2024-06

Locations

US (1)