Vital USA SpO2 Accuracy Comparison to Arterial Blood CO-Oximetry
Last updated on July 2021Recruitment
- Recruitment Status
- Completed
Summary
- Conditions
- Arterial Disease
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Testing was conducted under normal office environment conditions. The VitalDetect™ pulse oximetry was placed on the right index finger of all subjects to evaluate the SpO2 and pulse rate accuracy performance during steady state non-motion conditions. A Control Pulse Oximetry system was also placed on the subject to evaluate the stability of the draws and the real time oxygen saturation status. The subject was in a reclined position and connected to a breathing circuit, for administering medical grade oxygen and nitrogen. The gas flow delivery was adjusted for subject comfort. Arterial blood samples were drawn during simultaneous data collection from the control pulse oximeter and the test oximeters. The blood was immediately analyzed by Reference CO-Oximetry providing functional SpO2 for the basis of the SpO2 accuracy comparison. The pulse rate for the VitalDetect™ was compared to Reference ECG Heart Rate collected during the study.Masking: None (Open Label)Primary Purpose: Device Feasibility
Participation Requirements
- Age
- Between 18 years and 52 years
- Gender
- Both males and females
Description
An SpO2 accuracy comparison was conducted as part of the final validation of the VitalDetect™ pulse oximetry system. The study was conducted in accordance to Code of Federal Regulations (CFR) for Non-Significant Risk (NSR) investigational studies, following International Standards Organization (ISO)...
An SpO2 accuracy comparison was conducted as part of the final validation of the VitalDetect™ pulse oximetry system. The study was conducted in accordance to Code of Federal Regulations (CFR) for Non-Significant Risk (NSR) investigational studies, following International Standards Organization (ISO) 14155:2011 as appropriate and the pulse oximetry guidelines of ISO 80601-2-61:2017 applicable sections, and Pulse Oximeters - Premarket Notifications Submissions [510(k)s] Guidance For Industry and Food and Drug Administration Staff (issued: March 4, 2013). The purpose of this study was to validate the SpO2 accuracy of the VitalDetect™ pulse oximetry system during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. It was expected that the Accuracy Root Mean Square (ARMS) performance of the oximetry system would meet the required specification of ARMS of 3.0% or less. A secondary goal was to evaluate the pulse rate performance simultaneously collected over the SpO2 range covered. The Pulse Rate Accuracy Root Mean Square (Arms) performance of the VitalDetect™ pulse oximetry system, were expected to meet a specification of 3 bpm.
Tracking Information
- NCT #
- NCT04285411
- Collaborators
- Clinimark, LLC
- Investigators
- Principal Investigator: Arthur Ruiz, MD Avista Adventist Hospital
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