SpO2 System Accuracy Testing With Different Sensors

General Electric (GE)

Status: Completed

Conditions: Pulse Oximetry

Treatments: Device: Pulse oximetry

Study type: Interventional

Funder types: Industry

Identifiers

NCT01613222

118.02-2011-GES-0012

Details and patient eligibility

About

A study to test the accuracy of SpO2 sensors with various patient monitors, co-oximeters, and modules.

Full description

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.

Enrollment: 63 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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63 participants in 1 patient group

Pulse oximetry monitoring

Experimental group

Description:

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.

Treatment:

Device: Pulse oximetry