Evaluation of Sensifree's Alpha Sensor Signal Morphology Compared to Arterial Line and PPG Signal Morphologies
Completed · Not applicable
Conditions studied: Blood Pressure Measurement
In brief
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 pulse oximeter. The study will be split into two phases: the first phase will collect data for morphology analysis and algorithm development, the second phase will compare device performance to the reference invasive blood pressures. A secondary objective is to evaluate signal morphology changes due to changes in subject arm position.
Key facts
- Study ID
- NCT04100668
- Run by
- Sensifree Ltd.
- People needed
- 15
- Starts
- 2017-09-26
- Expected to finish
- 2017-09-29
- Last updated by the study team
- 2019-09-24
Who can join
Age: 20 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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
Where it is running
- Clinimark Lab — Louisville, Colorado, United States
Full record on ClinicalTrials.gov
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