SpO2 Sensor for Hypoxia
(SpO2 Dispo Trial)

Recruiting in Palo Alto (17 mi)

Overseen byMonica Rabanal, NP

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: GE Healthcare

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of the TruSignal sensor LED platform SpO2 sensor accuracy study with human volunteer participants is to collect SpO2 data from P-SA01PL and P-SP01PL prototype sensors and reference data to develop a calibration model for new TruSignal LED platform at different pigmentation values according to the Monk Skin Scale.

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 between 18 and 50 years old.

I am a person of any gender or race.

See 2 more

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.

See 9 more

Treatment Details

Interventions

SpO2 Sensor Testing (Procedure)

Trial OverviewThe 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

1Treatment groups

Experimental Treatment

Group I: SpO2 Measurements - All SubjectsExperimental Treatment1 Intervention

Participants participating in this study will be connected to eight (8) Portrait Mobile P-SA01PL/P-SP01PL prototype sensors provided by GEHC and two reference monitors, Nellcor N-600X V 1.6.0.0 and a forehead sensor, used as standard operating procedures at the site. Data will be collected using the Portrait Hub patient monitor. The participants are exposed to a desaturation protocol that sequentially decreases the SpO2 in a stepwise fashion. The goal is to achieve six stable oxygenation plateaus between 100 and 70% SpO2, while recording simultaneous SpO2 readings from the prototype and reference devices. The protocol is consistent with the ISO 80601-2-61 pulse oximetry standard.