Accuracy Validation of the Cadwell Pulse Oximetry System

Cadwell Industries

Status

Completed

Conditions

Anoxia

Treatments

Device: Disposable Sensor

Device: Control Pulse Oximetry

Device: Reusable Sensor

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT02842476

PR 2016-177

Details and patient eligibility

About

The purpose of this study is to evaluate the SpO2 accuracy and performance of the Cadwell Pulse Oximetry system during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry for SpO2 validation. The end goal is to show the SpO2 accuracy performance of the Cadwell Pulse Oximetry System. It is expected that the Accuracy Root Mean Square (Arms) performance of the Cadwell Pulse Oximetry System 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.

Full description

The SpO2 accuracy performance of the Cadwell Pulse Oximetry systems will be evaluated during non-motion conditions over the range of 70-100% SaO2 and compared to arterial blood samples assessed by COOximetry. 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 ISO 80601-2-61 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 fingers for the test sites. 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 COHb, MetHb or inconsistent data. Anomalous values will be removed from the analysis prior to pairing of the SpO2 and SaO2 data. The statistical analysis is performed on a minimum of 200 data points collected on at least 10 subjects for the range of 67% to 100% SaO2. Functional SaO2 as measured by Reference CO-Oximetry will be used as the basis for comparison. 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.

Enrollment

11 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Ability to understand and provide written informed consent
18 to 50 years of age
Non-smoker or who has not smoked within 2 days prior to the study.
Male or female
Any race

Exclusion criteria

Morbidly obese (defined as BMI >39.5)
Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull
Females who are pregnant, who are trying to get pregnant, or have a urine test positive for pregnancy on the day of the study
COHb levels >3% as assessed with a Masimo Radical 7 (Rainbow)
Respiratory conditions
Heart or cardiovascular conditions
Self reported health conditions
Blood clotting disorders
Severe contact allergies to standard adhesives, latex or other materials
Unwillingness or inability to remove colored nail polish from test digits
Other known health condition, should be considered upon disclosure in health