SpO2 Sensor for Hypoxia

(SpO2 Dispo Trial)

Overseen By Tanya Lange, LRCP, RRT, VA-BC

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: GE Healthcare

Must not be taking: Blood thinners, Aspirin

Disqualifiers: Obesity, Respiratory, Cardiovascular, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

32 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the study is to collect SpO2 data with simultaneous transfer standard SpO2 measurements data on human participants.

Research Team

Monica Rabanal, NP

Principal Investigator

Element Materials Technology

Eligibility Criteria

This trial is for volunteers who are willing to have their oxygen levels measured by a new type of wireless, disposable SpO2 sensor. There's no specific mention of health conditions or other criteria in the provided information.

Inclusion Criteria

Participant must have the ability to understand and provide written informed consent

I am a person of any gender or race.

I have not smoked in the last 2 days.

Exclusion Criteria

Participants who have smoked in the last 2 days or participants who have refrained, for at least 48 hours, with COHb levels greater than 3% as assessed per site standard operation procedure

Unwillingness or inability to remove colored nail polish or non-clear artificial nails from test digits

I am not pregnant or unable to become pregnant.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are connected to sensors and exposed to a desaturation protocol consistent with the ISO 80601-2-61 pulse oximetry standard

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

Treatment Details

Interventions

• SpO2 Sensor Testing

Trial Overview The study is testing the accuracy of prototype SpO2 sensors designed for a new TruSignal LED platform. It involves collecting data on oxygen saturation at various skin pigmentation levels as per the Monk Skin Scale.

Participant Groups

Group I: SpO2 Measurements - All Subjects Experimental Treatment 1 Intervention

Participants participating in this study will be connected to sensors. The participants are exposed to a desaturation protocol. The protocol is consistent with the ISO 80601-2-61 pulse oximetry standard.

Who Is Running the Clinical Trial?

GE Healthcare

Lead Sponsor

Trials

307

Recruited

634,000+

Fotis Vlachos

GE Healthcare

Chief Marketing Officer since 2024

PhD in Molecular Biology and Biochemistry from the University of Massachusetts, MBA from the Wharton School of the University of Pennsylvania

Peter J. Arduini

GE Healthcare

Chief Executive Officer since 2022

MBA from Northwestern University, BSc in Marketing from Susquehanna University