Continuous Non-Invasive Blood Pressure System Data Collection in Comparison to Invasive Radial Arterial Pressure

Study Overview
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Brief Summary
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The purpose of this study is to evaluate methods to modify blood pressure in humans and measure the effectiveness of such methods. A secondary outcome is to evaluate the performance of an investigational continuous non-invasive blood pressure (cNIBP) device created by Sensifree. The tests will per performed in non-hospitalized subjects under varied controlled conditions that include resting blood pressure and non-pharmacologically induced blood pressure changes.

Detailed Description
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On a first visit a screening procedure to verify inclusion / exclusion criteria are met will be conducted. On the primary procedure visit, data collection will begin with the subjects having the investigational device, ECG sensors, and 1 or more pulse oximetry sensors placed on them for data collection and to monitor their safety for the duration of the study. A physician will place an arterial line in the radial artery. The Sensifree cNIBP system will be calibrated with an oscillometric and/or auscultatory blood pressure cuff measurement taken on the arm opposite the arterial line. A series of blood pressure changes will be induced, including various combinations of methods.

Official Title
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Evaluation of Sensifree's PPG Based Continuous & Non-Invasive Blood Pressure Monitoring System in Comparison to Invasive Radial Arterial Line

Conditions
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Blood Pressure Measurement

Intervention / Treatment
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* Device: GE Datex-Ohmeda Oxy-F Finger Clip Pulse Oximeter Sensor
* Device: Arrow® arterial catheterization kit (Teleflex)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must have the ability to understand and provide written informed consent Subject must be willing and able to comply with study procedures and duration Exclusion Criteria: Subject with a BMI over 39 Deformities or abnormalities that may prevent proper application of the device under test Lateral difference in blood pressure greater than 5mmHg diastolic and 9mmHg systolic Tachycardia or resting heart rate less than 45 bpm Females who are pregnant, who are trying to get pregnant, (confirmed by positive urine pregnancy test unless the subject is known to be not of child-bearing potential) Subjects with known respiratory conditions such as: (self-reported) uncontrolled / severe asthma, flu, pneumonia / bronchitis, shortness of breath / respiratory distress, respiratory or lung surgery, emphysema, COPD, lung disease Subjects with known heart or cardiovascular conditions such as: (self-reported, except for blood pressure and ECG review) have had cardiovascular surgery have cardiac pacemakers and/or automatic internal cardio-defibrillator Chest pain (angina) Abnormal pulse pressure 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 Pulsus Paradoxus 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 head injury cancer / chemotherapy Subjects with known clotting disorders (self-reported) history of bleeding disorders or personal history of prolonged bleeding from injury history of blood clots hemophilia current use of blood thinner: prescription or daily use of aspirin Subjects with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors (self-reported) Subjects with a contact allergy to ultrasound gel. Subjects with prior or known allergies to iodine or lidocaine (or similar pharmacological agents, e.g. Novocaine) Failure of the Perfusion Index Ulnar/Ulnar+Radial Ratio test Subject is intoxicated during the time of the visit, or was intoxicated within 24 hours prior to study visit, as reported by the subject, or per study staff judgment. Other known health condition, should be considered upon disclosure in health assessment form

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: GE Datex-Ohmeda Oxy-F Finger Clip Pulse Oximeter Sensor|PPG based, fingertip mounted sensor, that measures the oxygen level (oxygen saturation) of the blood and generates a waveform|
|Device: Arrow® arterial catheterization kit (Teleflex)|Invasive monitoring of blood pressure via catheterization of the radial artery, displaying a continuous pressure waveform|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the magnitude of blood pressure change (measured in mmHg) cause by different isometric efforts in humans | Measure the effect of a combination of the following isometric efforts on a subject's blood pressure (measured in mmHg): Hand grip Weight lifting Leg static effort | 3-4 hours per subject | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure the accuracy of an investigational continuous non-invasive blood pressure (cNIBP) device | Comparison of BP values (Systolic, Diastolic, MAP) that are calculated by the investigational device to the BP values measured by the arterial line during isometric effort comprising a combination of the following isometric efforts on a subject's blood pressure: Hand grip Weight lifting Leg static effort | 3-4 hours per subject |