Status:
COMPLETED
Continuous Non-Invasive Blood Pressure System Data Collection in Comparison to Invasive Radial Arterial Pressure
Lead Sponsor:
Sensifree Ltd.
Conditions:
Blood Pressure Measurement
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 investigatio...
Detailed Description
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 inves...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 6 2020
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04456179
Start Date
February 3 2020
End Date
February 6 2020
Last Update
July 2 2020
Active Locations (1)
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1
Clinimark Lab
Louisville, Colorado, United States, 80027