Evaluation of Sensifree's Alpha Sensor Signal Morphology Compared to Arterial Line and PPG Signal Morphologies
Condition: Blood Pressure Measurement
Study type: Interventional

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 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.
    

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 (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.
    

Intervention name(s): Sensifree's Alpha sensor; Arrow® arterial catheterization kit (Teleflex); GE Datex-Ohmeda Oxy-F Finger Clip Pulse Oximeter Sensor
Intervention type(s): Device; Device; Device
Intervention description(s): RF based, wrist mounted sensor, that acquires a high fidelity signal originating at the radial artery, and constructs a pressure waveform; Invasive monitoring of blood pressure via catheterization of the radial artery, displaying a continuous pressure waveform; PPG based, fingertip mounted sensor, that measures the oxygen level (oxygen saturation) of the blood and generates a waveform
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science