What side effects are associated with this type of intervention?

Common treatments involving non-invasive measurement of peripheral oxygen saturation, such as oxygen therapy, generally have minimal side effects. However, some potential side effects include nasal dryness or irritation from nasal cannulas, headaches, and, in rare cases, oxygen toxicity if high concentrations are used for prolonged periods. Monitoring devices themselves, like pulse oximeters, are typically safe but may cause minor skin irritation or pressure sores if used continuously for extended periods.

What prior FDA approvals exist?

The FDA has approved several non-invasive devices for monitoring peripheral oxygen saturation (SpO2) in healthy subjects and patients. These include pulse oximeters, which are commonly used in both clinical and home settings to measure oxygen levels in the blood. Notable examples include devices from companies like Masimo, which have developed advanced pulse oximeters with high accuracy and reliability. These devices use light sensors to detect oxygen levels through the skin, providing a quick and painless method for monitoring respiratory health. Such technologies are crucial for managing conditions that affect oxygen saturation, ensuring timely intervention and treatment.

What other types of research exist?

A promising novel alternative to INVSENSOR00069 for non-invasive measurement of peripheral oxygen saturation in healthy subjects is the Samsung S9 smartphone, which has been clinically validated to meet full FDA/ISO requirements for pulse oximetry. This device offers a convenient and reliable option for monitoring SpO2 levels.

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Oxygen Sensor Accuracy in Healthy Subjects

N/A

Waitlist Available

Research Sponsored by Masimo Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-3 hours

Awards & highlights

Study Summary

This trial compares an oxygen sensor to blood tests to see how accurate it is.

Who is the study for?

This trial is for healthy adults aged 18-50, with normal hemoglobin levels (≥11 g/dL), blood pressure within specific limits, a heart rate of 45-90 bpm, and weighing at least 110 lbs. Participants must speak English and pass a health assessment. Those with certain blood disorders, skin conditions on their fingers, or vascular diseases are excluded.Check my eligibility

What is being tested?

The study tests the accuracy of the Masimo INVSENSOR00069 in measuring peripheral oxygen saturation (SpO2) by comparing it to arterial blood gas analysis results in healthy subjects.See study design

What are the potential side effects?

Since this trial involves non-invasive monitoring with an SpO2 sensor and standard ABG testing procedures, side effects are minimal but may include discomfort or minor bruising where sensors or needles are applied.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-3 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-3 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-3 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Peripheral oxygen saturation (SpO2) accuracy of INVSENSOR00069

Trial Design

1Treatment groups

Experimental Treatment

Group I: Test SubjectExperimental Treatment1 Intervention

All subjects who are enrolled into the test group and participate in data collection have the Masimo INVSENSOR00069.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

INVSENSOR00069

2023

N/A

~90

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The INVSENSOR00069 trial evaluates the accuracy of non-invasive peripheral oxygen saturation (SpO2) measurements. Common treatments related to oxygen saturation include supplemental oxygen therapy and pulse oximetry monitoring. Supplemental oxygen therapy increases the amount of oxygen in the blood, which is crucial for patients with respiratory conditions but generally not necessary for healthy subjects. Pulse oximetry, on the other hand, is a non-invasive method to monitor oxygen levels and ensure they remain within a normal range. For healthy subjects, accurate SpO2 monitoring can help detect early signs of hypoxemia or other respiratory issues, ensuring timely intervention and maintaining overall health.

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Who is running the clinical trial?

Masimo CorporationLead Sponsor

112 Previous Clinical Trials

13,036 Total Patients Enrolled

~56 spots leftby Jun 2025

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