Accuracy Validation of the Cadwell Pulse Oximetry System

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.

Study Overview

• Status: Completed
• Conditions: Anoxia
• Intervention / Treatment: Device: Disposable Sensor; Device: Reusable Sensor; Device: Control Pulse Oximetry

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.

• Study Type: Observational
• Enrollment (Actual): 11

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Following Salus Independent Review Board (IRB) approval for the Study Procedure Title: "Accuracy Validation of the Cadwell Pulse Oximetry System", Clinimark Study ID# PR 2016-177, eleven healthy adult volunteer subjects were enrolled into the study. The demographics for the study included five males and six females (age: 21-46yrs, weight: 118-220lbs, height: 60-74", BMI: 20.9-30.7). For the demographics based on race, the subject pool included one Black / African-American, three Asians (one of Indian descent), and seven White. The ethnicity for the group is four Hispanic, and seven Non-Hispanic / Non-Latino. The skin pigmentation / tones ranged from light to dark meeting the requirement of at least 2 darkly pigmented or 15 % of the subject pool whichever is larger.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Disposable Sensor; Adhesive based Pulse Oximeter Probes, Model S0136J	Device: 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.; Other Names: Model S0136J-L
Reusable Sensor; Reusable Pulse Oximeter Probes, Model S0080D	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.; Other Names: Model S0080D-S
Control Pulse Oximetry; Reference CO-Oximeters ABL80 Flex OSM (Radiometer), # 302125, 307205 IL682 (Instrumentation Laboratories), # 012511B (ILH), #012511A (ILG)	Device: Control Pulse Oximetry; A Clinimark Control Pulse Oximetry system was also placed on the subject to evaluate the stability of the draws.; Other Names: Reference Co-Oximeters, ABL80 Flex OSM (Radiometer): # 302125, 307205 IL682 (Instrumentation Laboratories): # 012511B (ILH), #012511A (ILG)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SpO2 Sensor Values	SpO2 values (%) from the Cadwell pulse oximetry device using disposable and reusable sensors were collected electronically at one second intervals.	Through study completion, an average of 1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial Oxygen Saturation	Each subject was presented with various levels of induced hypoxia resulting in stable oxygen saturation levels between 100% and 67% SaO2. Arterial blood draws were collected under non-motion conditions. The blood was immediately analyzed to measure the arterial oxygen saturation.	Through study completion, an average of 1 day

Collaborators and Investigators

• Sponsor: Cadwell Industries, Inc.
• Collaborators: Clinimark, LLC

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: July 15, 2016
• First Submitted That Met QC Criteria: July 22, 2016
• First Posted (Estimate): July 25, 2016

Study Record Updates

• Last Update Posted (Estimate): July 25, 2016
• Last Update Submitted That Met QC Criteria: July 22, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: pulse oximetry
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: PR 2016-177

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No