Blood Pressure Measurement Clinical Trial
Official title:
Evaluation of Sensifree's Alpha Sensor Signal Morphology in Comparison to Invasive Radial Arterial Line Pressure Waveform and PPG Signal Morphology
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.
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 (Visit 1) and 2 hours for data collection (Visit 2).
Data Collection, Visit 2, will be divided into two phases. Phase 1 will use up to 20 subjects
with the goal of collecting data for algorithm and sensor development. No requirements for
certain blood pressure populations are required for Phase 1. Once the analysis of the Phase 1
results is complete, Phase 2 will use up to 30 subjects with the following requirements to
test multiple blood pressure populations:
- No more than 25% will be normotensive
- At least 60% of the subjects will be hypertensive
- At least 15% of the subjects will be hypotensive
Visit 1- Screening Screening will be identical for both phases of the study. Subjects will be
screened for per the inclusion criteria, assuring the subject will be a good candidate for
the data collection portion of the study. If the subject does not meet the inclusion criteria
they will not be invited to participate in Visit 2. During screening, the subject's wrist
circumference will be recorded and measured for each arm. The clinician will perform
auscultatory blood pressure measurements on both arms to determine the lateral systolic and
diastolic blood pressure difference per Procedure 5.2.4.3.1. in the International Standards
Organization (ISO) 81060-2:2013. Using ultrasound, the clinician will also determine if the
subject has any bifurcations in the radial artery of each arm. Finally, the investigation
devices will be place on both wrists of the subject to determine if adequate signal can be
detected. If the subject meets all the inclusion criteria for screening they will be invited
to participate in the data collection portion of the study during Visit 2.
Visit 2- Screening Visit 2, the data collection portion of the study, will begin with the
volunteer test subject lying in the supine position. The subject will be reminded they may
withdraw from the study at any time. The subject will have the investigational device, ECG
sensors, and a pulse oximetry sensor placed on them for data collection and to monitor their
safety for the duration of the study. An arterial line will be placed in the radial artery,
contralateral to the investigational device, under sterile conditions by a physician. To
begin data collection; 10 minute periods of simultaneous invasive data from the arterial line
and the non-invasive signal from the investigational device will be recorded. Once the supine
recording sessions are complete, the subject will be raised to a seated position and the
pressure transducer will be recalibrated. The subject will then vary both their arm positions
simultaneously from heart level, to above heart level, and to below heart level to record the
changes in pressure due to movement.
Once all data has been collected, the radial arterial catheter will be removed by the
physician and constant pressure held on the arterial puncture for a minimum of 10 minutes.
The clinician will review any final questions with the subject, the subject will be provided
with phone numbers for questions pertaining to the participation in this study or
research-related injury or reaction post study. Follow-up with each subject will be conducted
within 5 days following participation in the study and will be conducted via telephone, text,
or email.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04976452 -
Identifying Learning Strategies to Improve Blood Pressure Measurement in Physical Therapy Education Programs
|
N/A | |
| Completed |
NCT04510753 -
Data Collection of Arterial Line Waveform and BP Values
|
||
| Completed |
NCT02447471 -
Agreement of the Nexfin™ Monitor With Non-invasive Blood Pressure Measurement
|
N/A | |
| Not yet recruiting |
NCT06198855 -
Automated Measurement of Blood Pressure in Waiting Room (AMBP-waiting)
|
||
| Completed |
NCT04132453 -
Continuous Blood Pressure and Waveform Measurements Comparison Between Invasive Arterial Line and PPG Sensor
|
||
| Completed |
NCT04456179 -
Continuous Non-Invasive Blood Pressure System Data Collection in Comparison to Invasive Radial Arterial Pressure
|
N/A |