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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new SpO2 sensor designed to measure blood oxygen levels. Participants will connect to sensors and follow a desaturation protocol, a standard procedure for testing pulse oximeters. The goal is to ensure the sensor accurately records oxygen levels under various conditions. Ideal participants are adults who do not smoke, have no respiratory issues, and are willing to follow study procedures.

As an unphased trial, this study offers participants the chance to contribute to the development of innovative health technology.

Do I need to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators to get a clear answer.

What prior data suggests that this SpO2 sensor is safe for human use?

Research has shown that SpO2 sensors, like the one tested in this trial, are generally safe and easy to use. These sensors measure blood oxygen levels without needing a blood sample. Studies have found that they provide accurate results in controlled environments. For example, a wearable ring used to measure SpO2 was accurate when the wearer remained still.

However, some issues have been reported with pulse oximeters, which also measure SpO2. Occasionally, the display may freeze during certain medical procedures, potentially leading to incorrect readings. Despite this, doctors and nurses frequently use pulse oximeters to check blood oxygen levels, indicating their safety for general use.

Overall, evidence supports the safety of SpO2 sensors for measuring blood oxygen levels. However, like any medical device, small risks remain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it seeks to improve how we monitor oxygen levels in the blood using SpO2 sensors, especially during hypoxic events. Unlike traditional pulse oximeters that may not always provide accurate readings under certain conditions, this study uses a desaturation protocol aligned with the ISO 80601-2-61 standard to thoroughly test the sensor's accuracy and reliability. The goal is to ensure these sensors can offer more precise and reliable data, which can be crucial in medical settings where every second counts. By potentially enhancing how we monitor patients' oxygen levels, this trial could lead to better patient outcomes and improved safety in clinical environments.

What evidence suggests that this SpO2 sensor is effective for measuring hypoxia?

Research has shown that SpO2 sensors usually measure blood oxygen levels accurately. One study found these devices to be very precise, with only a small error margin across different oxygen levels. Another report noted a low failure rate for SpO2 devices, around 4.5%. This evidence suggests that SpO2 sensors reliably check blood oxygen, crucial for spotting low oxygen levels, known as hypoxia. Overall, this technology seems effective for its purpose. Participants in this trial will connect to SpO2 sensors to evaluate their effectiveness in detecting hypoxia. ^{1 2 6 7 8}

Who Is on the Research Team?

Monica Rabanal, NP

Principal Investigator

Element Materials Technology

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10337940/

Investigating the accuracy of blood oxygen saturation ... A wide range of SpO2 measurements were reported (82.0-100.0%) and no explanation is offered for the range of results outside normal values. Co- ...

2. nature.com nature.com/articles/s41597-024-03065-x

A high altitude respiration and SpO2 dataset for assessing ... This report presents the Harespod dataset, an open dataset for high altitude hypoxia research, which includes respiration and SpO2 data.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2589537021003205

Performance of five pulse oximeters to detect hypoxaemia ... Out of all SpO2 measurements completed with the five test devices, a failure rate of 4·5% was recorded. The Utech handheld pulse oximeter had the highest ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11187508/

Performance of a Wearable Ring in Controlled Hypoxia As is shown, the test device maintains strong accuracy over the range of 70%-100% with an RMSE of 1.8% for the traditional ring or finger ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05245526

SpO2 Accuracy of Noninvasive Disposable Pulse Oximeter ... The accuracy of a noninvasive pulse oximeter sensor will be assessed by comparison to the oxygen saturation measurements from a laboratory blood gas analyzer.

6. patientsafety.pa.gov patientsafety.pa.gov/ADVISORIES/Pages/200506_25.aspx

Skin Integrity Issues Associated with Pulse Oximetry Advisory Some models freeze the SpO2 display during ESU activation, which may lead clinicians to mistakenly rely on an inaccurate measurement of oxygen saturation.

7. nature.com nature.com/articles/s41746-022-00665-y

Smartphone camera oximetry in an induced hypoxemia study A pulse oximetry value below 90% SpO2 is a common threshold used to indicate the need for medical attention, but other thresholds could be ...

8. fda.gov fda.gov/media/162709/download

FDA Executive Summary Review of Pulse Oximeters and ... Pulse oximeters are widely used by many types of healthcare providers and consumers to obtain an indirect measure (SpO2) of arterial blood ...