Accuracy Validation of the Cadwell Pulse Oximetry System

Anoxia Clinical Trial

Official title:

Accuracy Validation of the Cadwell Pulse Oximetry System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02842476
• Other study ID #: PR 2016-177
• Status: Completed
• Phase: N/A
• First received: July 15, 2016
• Last updated: July 22, 2016
• Start date: June 2016
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: Cadwell Industries, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Anoxia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Cadwell Industries, Inc.	Clinimark, LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No