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N/A N=10 Device Feasibility

Vital USA SpO2 Accuracy Comparison to Arterial Blood CO-Oximetry

Arterial Disease

Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcome: Primary: Evaluate SpO2 Accuracy Per Standards for Pulse Oximetry. — 3.1 percent

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Accuracy of the VitalDetect™ pulse oximetry system (Device)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Vital USA, Inc.
Primary completion
Nov 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Evaluate SpO2 Accuracy Per Standards for Pulse Oximetry.
3.1
SECONDARY
The Pulse Rate Accuracy Compared to ECG Heart Rate.
2.7

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

Eligibility Criteria

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,
  • flu,
  • 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)
  • diabetes,
  • uncontrolled thyroid disease,
  • kidney disease / chronic renal impairment,
  • history of seizures (except childhood febrile seizures),
  • epilepsy,
  • 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)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04285411). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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