Clinical Performance of Masimo INVSENSOR00040

NCT05332392 | Completed Results FDA Device

• 1 other identifier: CIP-1019
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to compare the accuracy of a noninvasive measurement of oxygen saturation and pulse rate to reference values obtained by a laboratory blood gas analyzer and a standard of care EKG monitor. Study procedures follow ISO-80601-2-61:2011 standard requirements for basic safety and essential performance of pulse oximeter equipment. Arterial blood samples will be collected from subjects while undergoing a controlled desaturation procedure wherein the concentration of oxygen inhaled is slowly reduced until the subject's arterial oxygen concentration is approximately 70%.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Oxygen Saturation (SpO2) Accuracy of INVSENSOR00040

  SpO2 performance will be determined by calculating the arithmetic root square mean (ARMS) value through the comparison of the noninvasive SpO2 measurement obtained from INVSENSOR00040 to the arterial oxygen saturation (SaO2) value obtained from a reference blood sample. The square root of the sum of the squares of bias and precision is computed as the ARMS Error Value. The desaturation range over which the accuracy is performed is 70-100%.

  1-5 hours

• Pulse Rate (PR) Accuracy of INVSENSOR00040

  Pulse Rate (PR) performance will be determined by calculating the ARMS value through the comparison of the PR values obtained from INVSENSOR00040 to the heart rate (HR) values obtained from a reference standard of care EKG monitor. The square root of the sum of the squares of bias and precision is computed as the ARMS Error Value. The PR/HR range over which the accuracy is calculated is determined by convenience sampling in a generally healthy population undergoing a desaturation procedure.

  1-5 hours

Study Arms (1)

INVSENSOR00040

EXPERIMENTAL

All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00040 device.

Device: INVSENSOR00040

Interventions

INVSENSOR00040 DEVICE

Noninvasive wearable health monitoring device

INVSENSOR00040

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.
• Subject has a hemoglobin value ≥ 11 g/dL.
• Subject's baseline heart rate is ≥ 45 bpm and ≤ 85 bpm.
• Subject's CO value is ≤ 3.0% FCOHb.
• Subject's 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.
• Subject is able to read and communicate in English and understands the study and the risks involved.

You may not qualify if:

• Subject whose skin is not intact and/or has tattoos in the area of device placement (e.g., wrist).\*
• Subject is pregnant.
• Subject has a BMI \> 35.
• 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 symptomatic 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

aalghazi@masimo.com

949-297-7437

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: April 11, 2022
• First Posted: April 18, 2022
• Study Start: April 14, 2022
• Primary Completion: April 13, 2023
• Study Completion: April 13, 2023
• Last Updated: June 11, 2024
• Results First Posted: February 28, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)