Accuracy Validation of a Pulse Oximetry Monitor

SpO2 Accuracy Validation of a USB Pulse Oximetry Monitor Interface Cable Via Reference Co-Oximetry

The purpose of this study is to conduct an oxygen saturation (SpO2) accuracy validation comparing prototype pulse oximeter oxygen saturation measurements directly to arterial blood saturation during non-motion conditions over the range of 60-100% SaO2 as measured by Reference CO-Oximetry. Additionally, the prototype pulse oximeter pulse rate measurements will be compared to 3-lead ECG heart rate measurements made via a multi-parameter monitor.

Study Overview

• Status: Withdrawn
• Conditions: Healthy

Detailed Description

The description of this study is to conduct an oxygen saturation (SpO2) accuracy validation comparing prototype pulse oximeter oxygen saturation measurements directly to arterial blood saturation during non-motion conditions over the range of 60-100% SaO2 as measured by Reference CO-Oximetry. Additionally, the prototype pulse oximeter pulse rate measurements will be compared to 3-lead ECG heart rate measurements made via a multi-parameter monitor.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Louisville, Colorado, United States, 80027
      • Clinimark

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will be ten to fifteen male and female subjects of any race, ranging in pigmentation from light to dark to meet the study design requirements

Description

Inclusion Criteria:

• healthy
• non-smoking, or who have refrained from smoking for 2 days
• male or female of any race
• 18-45 years.
• Subjects must have the ability to understand and provide written informed consent as well as be willing to comply with study procedures.
• To be eligible to participate in the study, the subject must clear a recent physical (12-lead ECG, medical history and blood test for sickle cell disease.) prior to enrollment

Exclusion Criteria:

• - morbid obesity (defined as BMI > 39.5),
• injuries, deformities or abnormalities or piercings that may prevent proper application of the device under test, compromised circulation,
• subjects with known respiratory conditions (smokers with COHb levels >3%, flu, pneumonia, bronchitis, shortness of breath/ respiratory distress, severe asthma, emphysema, COPD),
• subjects with known heart or cardiovascular conditions (uncontrolled hypertension, heart arrhythmias other than sinus arrhythmia, previous heart attack, blocked artery, history of myocardial ischemia, angina, myocardial infarction, congestive heart failure or cardiomyopathy, history of stroke, transient ischemic attack or carotid artery disease),
• other known health condition (diabetes, thyroid disease, kidney disease / chronic renal impairment, history of seizures (except childhood febrile seizures) or epilepsy, or unexplained syncope, recent history of frequent migraine headaches, recent head injury, cancer / chemotherapy
• women actively trying to get pregnant or are pregnant,
• clotting disorders (history of bleeding disorders or current use of blood thinners, Hemophilia, blood clots)
• Sickle cell disease
• Severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors
• Unwillingness or inability to remove colored nail polish or artificial nails from test digit(s)
• Prior or known allergies to: lidocaine (or similar pharmacological agents, e.g., Novocain) or heparin
• Recent arterial cannulation (i.e., less than 30 days prior to study date), Six or more arterial cannulations of each (right & left) radial artery, history of clinically significant complications from previous arterial cannulation

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The OxiCable pulse rate measurement performance is an ARMS of 3 or better over the full range 60-100% SaO2.	2.5 hours

Collaborators and Investigators

• Sponsor: Medtronic - MITG
• Collaborators: Clinimark, LLC
• Investigators: Principal Investigator: David Ransom, MD, Clinimark, LLC

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Anticipated): January 1, 2017
• Study Completion (Anticipated): January 1, 2017

Study Registration Dates

• First Submitted: July 14, 2015
• First Submitted That Met QC Criteria: July 21, 2015
• First Posted (Estimate): July 22, 2015

Study Record Updates

• Last Update Posted (Estimate): October 18, 2016
• Last Update Submitted That Met QC Criteria: October 14, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Hypoxia
• Other Study ID Numbers: COVMOPR0499

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: This study was cancelled.