bp data collection- squid system

BP Data collection-

SQUID system

© 2020 Valencell, Inc


Request for proposalsValencell, Inc seeks research units with experience and capable of

gathering blood measures from hypertensive patients (in a resting

condition).

Research unit shall currently have access to a “Stage 2” hypertensive

population and have the ability to collect both auscultatory and

oscillometric blood pressure.


OverviewPurpose: Data collection for the development of an accurate cuff-less blood

pressure monitoring technology that can be integrated into a device that people

already use each day.

Objective: Collection of raw data from Valencell sensors along with reference

blood pressure data.

Participants: n≥100 with SBP>150

Hardware: Various Valencell sensors used will depend on the clinical site.

Possible sensors: Earbud, hearing aid, finger sensor, wrist sensor. Data

collected via PC based application.

Methods: Single session of BP measures (option to come in more than once)

Protocol: following slide


Protocol1. Gather demographic information by utilizing Valencell provided application (5 minutes)

• Patient number, age, gender, weight, height, smoking status, blood pressure meds

2. Device Placement followed by 10 min seated (10-15 minutes) (not all sensors will be utilized at some clinical sites)

• Placing earbud in ear and assuring proper gel sizing

• Placing hearing aid in ear including utilizing an otoscope to inspect ear, utilizing the proper ear tip size

• Place wristband on wrist “snug and flat” against the skin proximal to the wrist bones

• Place finger lightly on sensor

3. Manual blood pressure assessment

• Trained individual will be determining blood pressure for each subject using a stethoscope and blood pressure cuff

4. Automatic blood pressure assessment

• Utilize a medical grade automatic blood pressure cuff

5. Gather sensor data (2 minutes total)

• Sensors being utilized (i.e. earbud, hearing aid, wrist and finger sensor)

6. Second manual and automatic blood pressure assessment.

7. Second sensor data collection (2 minutes total)

8. Third manual and automatic blood pressure assessment.

Total session duration = 30-45 minutes


System- SQUID wired data collector• Central hub - 4 wired DUTS (sensors) (depending on clinical site different

sensors may be utilized)

• Earbud

• Hearing aid

• Wrist

• Finger

• Software- SQUID data collector

• Walks through data collection step by step

• Syncs over Wi-Fi

• Paper copy

• Data checking, backup and notes


Data collection set-up


• If this data collection effort is of interest to your organization please answer the following questions:

• Please describe the clinical setting at which you collect (or will collect) the data.

• In a typical week how many patients (subjects) are seen with a systolic blood pressure greater than 150?

• Would these patients (subjects) be able to sit in a chair for blood pressure data collection?

• What is the typical health condition of these patients (subjects)?

• Do you have trained staff that are proficient in conducting manual blood pressure measures?

• Does anyone in your staff have familiarity with evaluating new medical devices?

• Would the patients (subjects) available be willing to provide up to 40 minutes of their time for data collection, assuming they were compensated?

• Have you conducted data collection for research purposes utilizing patients with hypertension? If so, please summarize the type of study performed.

• Have you or your team published results from clinical research studies?

bp data collection- squid system

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