NCT03565679

SpO2 Accuracy Comparison of Medline ReNewal Sensors to Arterial Blood CO-Oximetry

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Medline Industries · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this clinical study is to validate the SpO2 accuracy of the Medline ReNewal pulse oximetry sensors during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. The end goal is to provide supporting documentation for the SpO2 accuracy validation of the ReNewal sensors. It is required that the Accuracy Root Mean Square (ARMS) performance of the ReNewal pulse oximetry sensors will meet a specification of 3 or better in non-motion conditions for the range of 70 - 100% SaO2 thereby demonstrating an acceptable SpO2 accuracy performance specification.

Detailed description

An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. Pulse oximetry monitoring is considered a standard physiological measurement and is used by clinicians in everyday situations to estimate arterial oxygen saturation. Because an arterial sample of blood is not required to make the measurement, the pulse oximeter can provide non-invasive real time information. The clinical use of pulse oximeters has reduced the frequency and necessity of invasive arterial blood sampling and has helped to improve patient safety by providing continuous information to clinicians about patients' oxygenation status. The Medline ReNewal Reprocessed pulse oximeter sensors are indicated for single patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required. Following clinical use, each sensor is returned to Medline ReNewal where it is cleaned, disinfected, and packaged for an additional clinical use. Each sensor is tracked through the reprocessing cycle to monitor the number of times the sensor has been reprocessed. The purpose of this study will be to test the accuracy of the SpO2 component of the devices. The SpO2 accuracy performance of ReNewal pulse oximetry sensors will be evaluated during non-motion conditions over the range of 70-100% SaO2 and compared to arterial blood samples assessed by CO-Oximetry. A minimum of 10 healthy adult subjects, ranging in pigmentation from light to dark, will be enrolled in the study to meet the study design requirements defined by International Organization for Standardization (ISO) 80601-2-61:2011 and by the FDA's Guidance for Pulse Oximeters (March 4, 2013). The subjects will have an arterial catheter placed in the radial artery to allow for simultaneous blood samples during stable plateaus of induced hypoxic levels. The investigational devices will be placed on the fingers of both hands for the test sites per the instructions for use. Simultaneous data collection will be set up for each of the systems under test. For the data analysis, the control oximeter will be used to assess the stability of each data point. Data that is found to be unstable will be removed prior to the comparative analysis. Next the CO-Oximeter data will be reviewed to make sure it does not contain any anomalous values such as elevated, low or inconsistent carboxyhemoglobin (COHb), methemoglobin (MetHb), or total hemoglobin (tHb) data. Anomalous values will be removed from the analysis prior to pairing of the SpO2 and SaO2 data. The Accuracy Root Mean Square (ARMS) calculation is used to determine the SpO2 accuracy performance. Success will be achieved with an ARMS of 3 or better showing equivalence to the Gold Standard Reference CO-Oximetry providing documentation to support SpO2 accuracy claims for the investigational device(s). The study population will include 10-15 healthy non-smoking (or has refrained from smoking for 2 days) competent adults 18-50 years of age. The subject selection will be an equitable distribution of males and females of any race with varying skin tones including at least 2 darkly pigmented subjects or 15% of the subject pool, whichever is larger. Data collection will occur over a 2-5 day period for this study population. Follow-up with each subject will be conducted within 5 days following participation in the study and will be conducted via telephone, text or email.

Conditions

• Arterial Oxygen Saturation
• Healthy

Interventions

Type	Name	Description
DEVICE	MEDLINE RENEWAL PULSE OXIMETRY SENSORS	An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. Pulse oximetry monitoring is considered a standard physiological measurement and is used by clinicians in everyday situations to estimate arterial oxygen saturation. Because an arterial sample of blood is not required to make the measurement, the pulse oximeter can provide non-invasive real time information.
DEVICE	CO-OXIMETRY SENSORS	A whole blood analyzer (CO-Oximeter) is used as the reference standard device for obtaining the functional SaO2 value from arterial blood samples obtained during the study.

Timeline

• Start date: 2018-05-09
• Primary completion: 2018-05-10
• Completion: 2018-05-10
• First posted: 2018-06-21
• Last updated: 2019-06-18
• Results posted: 2019-06-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study