SpO2 System Accuracy Testing With Diffe… | Clinical Trial

Key information

Conditions

Pulse Oximetry

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinimark

Louisville, Colorado, 80027, United States

About this study

The U-TruSignal with different sensors is feasible for noninvasive and continuous SpO2 monitoring and meets the specified measurement accuracy when compared to a co-oximetry gold reference.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Ability to provide written informed consent or have a legally authorized representative provide written informed consent
Subjects who are 18-55 years of age
Subjects must be willing and able to comply with study procedures
HbCO<3% (for smokers only)

Exclusion criteria

Subject or a legally authorized representative is unable to provide written inform consent.
Subjects that are considered morbidly obese (defined as BMI > 39.5),
Subjects with injuries, deformities or abnormalities that may prevent proper application of the device under test,
Smokers with COHb levels >3% or subjects who have smoked within two (2) days. Subjects will be screened for COHb levels of >3% with a Masimo Radical 7 (Rainbow).
Subjects with known respiratory conditions (uncontrolled asthma, head cold, flu, pneumonia / bronchitis, respiratory distress / respiratory or lung surgery, emphysema, COPD, lung disease),
Subjects with known heart or cardiovascular conditions,
Female subjects that are actively trying to get pregnant or are pregnant,
Subjects taking blood thinners or medications with aspirin or other antiplatelet medication in them (applies only to arterial draw study),
Subjects with Systolic blood pressure >140mmHg,
Subjects with Diastolic blood pressure >100mmHg,
Subjects with heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia

Treatment and study plan

Pulse oximetry

Device

Pulse oximetry measurement using SpO2 sensors, patient monitors, co-oximeters, and various modules.

Primary outcomes

Accuracy Root Mean Square (ARMS)

Time frame: 60 minutes

The Accuracy Root Mean Square (ARMS) calculation is used to measure accuracy of the test SpO2 device compared to reference SpO2 device. A scatterplot is created with the forehead sensor saturation on the y-axis and the measured blood saturation on the x-axis. The line of identity is drawn representing the ideal points, meaning that the forehead sensor saturation is always the same as the blood saturation. The dispersion of the actual data points around the line of identity can be measured using a statistical calculation called Arithmetic Root Mean Square (ARMS). The smaller ARMs the closer the data points lie around the line of identity, representing a more accurate sensor as accurate and appropriate. Data analysis follows ISO 80601-2-61, 2011, Annex EE and the FDA Guidance Document for Pulse Oximeters (FDA Draft Guidance, July 19, 2007).

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Registry information

Official study title

SpO2 System Accuracy Testing

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Jun 7, 2012
Registry last updated: Feb 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed