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

Completed · Not applicable

Conditions studied: Blood Pressure Measurement

In brief

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.

Key facts

Study ID

NCT04456179

Run by

Sensifree Ltd.

People needed

6

Starts

2020-02-03

Expected to finish

2020-02-06

Last updated by the study team

2020-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Clinimark Lab — Louisville, Colorado, United States

Full record on ClinicalTrials.gov

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