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Accuracy Validation of the Cadwell Pulse Oximetry System

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ClinicalTrials.gov Identifier: NCT02842476
Recruitment Status : Completed
First Posted : July 25, 2016
Last Update Posted : July 25, 2016
Sponsor:
Collaborator:
Clinimark, LLC
Information provided by (Responsible Party):
Cadwell Industries, Inc.

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.

Condition or disease Intervention/treatment
Anoxia 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.

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Study Type : Observational
Actual Enrollment : 11 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Accuracy Validation of the Cadwell Pulse Oximetry System
Study Start Date : June 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

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




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


Secondary Outcome Measures :
  1. Arterial Oxygen Saturation [ Time Frame: Through study completion, an average of 1 day ]
    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.


Biospecimen Retention:   Samples With DNA
Arterial blood samples were drawn during simultaneous data collection from the test devices. The blood was immediately analyzed by Reference CO-Oximetry providing functional SaO2 for the basis of the SpO2 accuracy comparison.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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
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Responsible Party: Cadwell Industries, Inc.
ClinicalTrials.gov Identifier: NCT02842476    
Other Study ID Numbers: PR 2016-177
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: July 25, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Cadwell Industries, Inc.:
pulse oximetry
Additional relevant MeSH terms:
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Hypoxia
Signs and Symptoms, Respiratory