SpO2 Sensor for Hypoxia
(SpO2 Dispo Trial)
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.12345Why 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.12678
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are connected to sensors and exposed to a desaturation protocol consistent with the ISO 80601-2-61 pulse oximetry standard
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
GE Healthcare
Lead Sponsor
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
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- ...
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.
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 ...
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 ...
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.
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.
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 ...
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 ...
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