Status:
COMPLETED
Evaluation of Sensifree's Alpha Sensor Signal Morphology Compared to Arterial Line and PPG Signal Morphologies
Lead Sponsor:
Sensifree Ltd.
Conditions:
Blood Pressure Measurement
Eligibility:
All Genders
20-55 years
Phase:
NA
Brief Summary
The purpose of the protocol is to compare Sensifree Alpha sensor signal morphology, measured at the radial artery, to an invasive arterial line pressure signal and the oxygen saturation as read by a p...
Detailed Description
This study is a single-center, non-randomized study with a maximum of 50 subjects. The duration of the study for each subject test is expected to take approximately 3 hours: 1 hour for screening (Visi...
Eligibility Criteria
Inclusion
- General:
- 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
- Screening and Phase 1:
- Subject is from 20 to 55 years old.
- Subject has wrist circumference size within 145 and 220mm for both arms.
- Subjects with lateral blood pressure difference (auscultatory cuff based measurement) is less than: 15 mmHg for systolic blood pressure. 10 mmHg for diastolic blood pressure.
- Subjects with investigational device signal quality higher than a predefined value
- Subjects with similar investigational devices signals between their two arms.
- Phase 2 (all requirements as Phase 1 except):
- Subject is from 20 to 85 years old.
- At least 60% of subjects will have hypertensive blood pressure values (goal) (systolic \>140 mmHg and/or diastolic \>90 mmHg)
- At least 15% of subjects will have hypotensive blood pressure values (goal) (systolic \<110 mmHg and/or diastolic \<60 mmHg).
- No more than 25% of subjects will have normotensive blood pressure values (goal) (systolic from 110 to 140 mmHg and/or diastolic from 60 to 90 mmHg).
Exclusion
- Subject with a BMI over 39
- Deformities or abnormalities that may prevent proper application of the device under test
- Females who are pregnant, who are trying to get pregnant, or have a urine test positive for pregnancy on the day of the study
- 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
- Subject with a heart rate of less than 45 BPM
- 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
- Subjects with heart rate below 45 BPM.
Key Trial Info
Start Date :
September 26 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 29 2017
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04100668
Start Date
September 26 2017
End Date
September 29 2017
Last Update
September 24 2019
Active Locations (1)
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1
Clinimark Lab
Louisville, Colorado, United States, 80027