Results of the SpO2 and Pulse Rate Accuracy Comparison of VitalDetect™ to Arterial Blood CO-Oximetry and Reference ECG
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Vital USA, Inc.
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Evaluate SpO2 Accuracy Per Standards for Pulse Oximetry.
Study Overview
Brief Summary
Clinical Investigation Plan: Vital USA SpO2 Accuracy Comparison to Arterial Blood CO-Oximetry Study ID# PR 2019-353, Version: Rev 1, Date: 15 Oct 2019 Study Dates: November 4-5, 2019
Detailed 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) 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 52 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •10-15 Adults with a minimum of 3 males and a minimum of 3 females, with the balance made up of either
- •Subject must have the ability to understand and provide written informed consent
- •Subject is 18 to 50 years of age
- •Subject must be willing and able to comply with study procedures and duration
- •Subject is a non-smoker or who has not smoked within 2 days prior to the study
Exclusion Criteria
- •Subject is considered as being morbidly obese (defined as BMI >39.5).
- •Compromised circulation, injury, or physical malformation of fingers, wrist, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the particular sites utilized.)
- •Female subjects that are actively trying to get pregnant or are pregnant (confirmed by positive urine pregnancy test unless the subject is known to be not of child-bearing potential).
- •Smoker Subjects who have refrained will be screened for COPD levels >3% as assessed with a Radical 7 (Rainbow)
- •Subjects with known respiratory conditions such as: (self-reported):
- •uncontrolled / severe asthma,
- •pneumonia / bronchitis,
- •shortness of breath / respiratory distress,
- •unresolved respiratory or lung surgery with continued indications of health issues,
- •emphysema, COPD, lung disease.
- •Subjects with known heart or cardiovascular conditions such as: (self-reported, except for blood pressure and ECG review)
- •hypertension: systolic >140mmHg, Diastolic >90mmHg on 3 consecutive readings (reviewed during health screen).
- •have had cardiovascular surgery
- •Chest pain (angina)
- •heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia (reviewed during health screen)
- •previous heart attack
- •blocked artery
- •unexplained shortness of breath
- •congestive heart failure (CHF)
- •history of stroke
- •transient ischemic attack
- •carotid artery disease
- •myocardial ischemia
- •myocardial infarction
- •cardiomyopathy
- •Self-reported health conditions as identified in the Health Assessment Form (self-reported)
- •uncontrolled thyroid disease,
- •kidney disease / chronic renal impairment,
- •history of seizures (except childhood febrile seizures),
- •history of unexplained syncope,
- •recent history of frequent migraine headaches,
- •recent symptomatic head injury (within the last 2 months)
- •cancer / chemotherapy
- •Subjects with known clotting disorders (self-reported)
Arms & Interventions
ARMS SpO2 70-100%
Comparison to Reference CO-Oximetry
Intervention: Accuracy of the VitalDetect™ pulse oximetry system (Device)
Outcomes
Primary Outcomes
Evaluate SpO2 Accuracy Per Standards for Pulse Oximetry.
Time Frame: 90 Seconds
This study was a comparative, single-center, non-randomized study conducted to evaluate the SpO2 accuracy per standards and guidelines identified above for SpO2 accuracy for pulse oximetry equipment over the range of 70-100% SaO2 under non-motion conditions. Arterial blood sampling measured by functional SaO2 CO-Oximetry, was used as the basis for comparison. As a secondary goal, the pulse rate accuracy was compared to ECG Heart Rate realized over the range throughout the hypoxia procedure. Testing was conducted under normal office environment conditions.
Secondary Outcomes
- The Pulse Rate Accuracy Compared to ECG Heart Rate.(90 Seconds)