Accuracy Validation of the Cadwell Pulse Oximetry System

NCT ID: NCT02842476

Last Updated: 2016-07-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 11 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2016-06-30

Brief Summary

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.

Detailed 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.

Conditions

Anoxia

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Disposable Sensor

Adhesive based Pulse Oximeter Probes, Model S0136J

Disposable Sensor

Intervention Type: DEVICE

Two adhesive based Pulse Oximeter Probes, S0136J-L were connected to the Cadwell Pulse Oximetry and then placed on each subject to evaluate the SpO2 accuracy performance during steady state non-motion conditions.

Reusable Sensor

Reusable Pulse Oximeter Probes, Model S0080D

Reusable Sensor

Intervention Type: DEVICE

Two soft reusable Pulse Oximeter Probes, Model S0080D-S were connected to the Cadwell Pulse Oximetry and then placed on each subject to evaluate the SpO2 accuracy performance during steady state non-motion conditions.

Control Pulse Oximetry

Reference CO-Oximeters ABL80 Flex OSM (Radiometer), # 302125, 307205 IL682 (Instrumentation Laboratories), # 012511B (ILH), #012511A (ILG)

Control Pulse Oximetry

Intervention Type: DEVICE

A Clinimark Control Pulse Oximetry system was also placed on the subject to evaluate the stability of the draws.

Interventions

Disposable Sensor

Two adhesive based Pulse Oximeter Probes, S0136J-L were connected to the Cadwell Pulse Oximetry and then placed on each subject to evaluate the SpO2 accuracy performance during steady state non-motion conditions.

Intervention Type: DEVICE

Reusable Sensor

Two soft reusable Pulse Oximeter Probes, Model S0080D-S were connected to the Cadwell Pulse Oximetry and then placed on each subject to evaluate the SpO2 accuracy performance during steady state non-motion conditions.

Intervention Type: DEVICE

Control Pulse Oximetry

A Clinimark Control Pulse Oximetry system was also placed on the subject to evaluate the stability of the draws.

Intervention Type: DEVICE

Other Intervention Names

Model S0136J-L; Model S0080D-S; Reference Co-Oximeters, ABL80 Flex OSM (Radiometer): # 302125, 307205 IL682 (Instrumentation Laboratories): # 012511B (ILH), #012511A (ILG)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Clinimark, LLC

OTHER

Sponsor Role: collaborator

Cadwell Industries, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

PR 2016-177

Identifier Type: -

Identifier Source: org_study_id