Accuracy Validation of a Pulse Oximetry Monitor

Withdrawn before enrolling

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT02506010

Run by

Medtronic - MITG

People needed

0

Starts

2016-11-01

Expected to finish

2017-01-01

Last updated by the study team

2016-10-18

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• - 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

Where it is running

• Clinimark — Louisville, Colorado, United States

Full record on ClinicalTrials.gov

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