An observational study in Anoxia, sponsored by Cadwell Industries, Inc.. Completed. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-07-25.
Sponsored by Cadwell Industries, Inc. · Observational
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.
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.
1,231 studies on the registry are indexed under Hypoxia; 241 are open to participants now.
This study's enrollment of 11 is below the median of 67 across 335 observational studies indexed under Hypoxia.
Browse Hypoxia studies →This is the only study on the registry with Cadwell Industries, Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Adhesive based Pulse Oximeter Probes, Model S0136J
Device: Disposable Sensor
Reusable Pulse Oximeter Probes, Model S0080D
Device: Reusable Sensor
Reference CO-Oximeters ABL80 Flex OSM (Radiometer), # 302125, 307205 IL682 (Instrumentation Laboratories), # 012511B (ILH), #012511A (ILG)
Device: Control Pulse Oximetry
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.
Also known as: Model S0136J-L
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.
Also known as: Model S0080D-S
A Clinimark Control Pulse Oximetry system was also placed on the subject to evaluate the stability of the draws.
Also known as: Reference Co-Oximeters, ABL80 Flex OSM (Radiometer): # 302125, 307205 IL682 (Instrumentation Laboratories): # 012511B (ILH), #012511A (ILG)
SpO2 Sensor Values
SpO2 values (%) from the Cadwell pulse oximetry device using disposable and reusable sensors were collected electronically at one second intervals.
Time frame: Through study completion, an average of 1 day
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.
Time frame: Through study completion, an average of 1 day
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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