Effect of Skin Pigmentation and Race/Ethnicity Factors on the Accuracy of Masimo Pulse Oximeters

NCT04889222 | Terminated Results

• 1 other identifier: TP-21243
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to compare the accuracy of a noninvasive measurement of oxygen saturation compared to reference values obtained by a laboratory blood gas analyzer. Subgroups will be analyzed by skin pigmentation and self-identified race/ethnicity information. 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 (1)

• Oxygen Saturation (SpO2) Accuracy of INVSENSOR00050

  Performance of the INVSENSOR00050 sensor will be determined by comparing the noninvasive oxygen saturation measurement (SpO2) of the pulse oximeter sensors to the arterial oxygen saturation (SaO2) value obtained from a reference blood sample and calculating the accuracy root mean square (ARMS) value. The ARMS value will be reported as % of oxygen saturated hemoglobin.

  1-5 hours

Secondary Outcomes (2)

• Comparison of the Median Bias Between Subgroups for the INVSENSOR00050 Sensor

  1-5 hours

• Comparison of the Median Bias Between Subgroups for the RD SET SpO2 Sensors

  1-5 hours

Study Arms (1)

Pulse oximeters

EXPERIMENTAL

All subjects who are enrolled into the test group and participate in data collection receive the noninvasive pulse oximeter sensors.

Device: INVSENSOR00050; Device: RD SET SpO2

Interventions

INVSENSOR00050 DEVICE

Noninvasive pulse oximeter sensor

Pulse oximeters

RD SET SpO2 DEVICE

Noninvasive pulse oximeter sensor

Pulse oximeters

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 ≤ 2.0% 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 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.
• 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.\*

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

aalghazi@masimo.com

949-297-7437

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: May 17, 2021
• Study Start: April 5, 2021
• Primary Completion: April 29, 2021
• Study Completion: April 29, 2021
• Last Updated: December 1, 2022
• Results First Posted: December 1, 2022

Record last verified: 2022-11

Locations

US (1)