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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

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Masimo CorporationLead Sponsor

111 Previous Clinical Trials

12,988 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor currently open to participants?

"Correct. Records on clinicaltrials.gov show that this endeavour, which was initially posted November 1st 2023, is still in the process of recruiting participants. Approximately 18 individuals must be sourced from a single medical centre."

Answered by AI

How many individuals can participate in this medical experiment?

"Yes, as per the information hosted on clinicaltrials.gov this medical investigation is actively seeking participants. The trial was initially uploaded November 1st 2023 and recently amended on the same date. A total of 18 patients are required to be admitted from a single site for this study."

Answered by AI

Is the age parameter for this experiment limited to octogenarians or below?

"For those eligible to participate in this study, the age requirement is between 18 and 50. However, there are 64 trials for participants younger than 18 years old and 406 studies available for people older than 65."

Answered by AI

Who can participate in this testing protocol?

"Requirements for being accepted to this medical trial include age (18-50) and general health. At present, the research team is aiming to recruit 18 individuals into their study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Clinical Validation for SpO2 Function of Masimo INVSENSOR00069

2023. "Clinical Validation for SpO2 Function of Masimo INVSENSOR00069". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06120777.