Performance of Masimo MightySat Pulse Oximeter in Differing Levels of Skin Pigmentation

NCT05083351 | Completed Results FDA Device

• 1 other identifier: CIP-1004
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of the noninvasive oxygen saturation (SpO2) performance of the noninvasive Masimo MightySat against reference arterial blood samples analyzed by a laboratory CO-oximeter reference instrument. The study will include different subgroups to assess the performance across different genders and skin pigmentation.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• SpO2 Accuracy of the MightySat Pulse Oximeter

  The SpO2 accuracy of the MightySat pulse oximeter was determined by calculating the root mean-squared (rms) difference between the measured values (SpO2) to the reference values (SaO2) in accordance with ISO-80601-2-61. Arms= √(∑(i=1 to n) ((SpO2\_i-SaO2\_i )\^2 ))/n.

  1-5 hours

Study Arms (1)

MightySat

EXPERIMENTAL

All subjects who are enrolled into the test group and participate in data collection have the noninvasive MightySat pulse oximeter applied on their finger(s).

Device: MightySat

Interventions

MightySat DEVICE

Noninvasive pulse oximeter

MightySat

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: Director, Clinical Lab Operations
• Organization: Masimo

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: October 7, 2021
• First Posted: October 19, 2021
• Study Start: October 13, 2021
• Primary Completion: December 17, 2021
• Study Completion: December 17, 2021
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-08

Locations

US (1)