Non Invasive Continuous Blood Pressure Sensor

Piezoelectric Sensors for Non-invasive Continuous Arterial Blood Pressure Measurements

The primary objective of this study is to collect training data in order to establish a method for correlating arterial blood pressure with voltage output signals from a non-invasive piezoelectric array sensor placed on the skin superficial to the radial artery.

Study Overview

• Status: Completed
• Conditions: Blood Pressure; Anesthesia; Arterial Line

Detailed Description

The primary objective of this study is to collect training data in order to establish a method for correlating arterial blood pressure with voltage output signals from a non-invasive piezoelectric array sensor placed on the skin superficial to the radial artery. The development of this sensor could allow for non-invasive continuous measurement of arterial blood pressure.

The key hypothesis is: if the piezoelectric array sensor can detect pulsatile pressure waves when placed on a near surface artery and pulse wave analysis has been shown to allow for accurate beat-to-beat estimation of blood pressure, then the device placed superficial to a near surface artery should allow for the non-invasive estimation of continuous blood pressure.

Secondary objectives include identification of any significant ergonomic and motion artifact issues that could affect sensor utilization in future applications.

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

• Study Contact: Name: Alexander T Abess, MD; Phone Number: 6036505922; Email: alexander.t.abess@hitchcock.org
• Study Contact Backup: Name: Alessandra C Bryan, BS BA; Phone Number: 6036500360; Email: alessandra.c.bryan@hitchcock.org

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth Hitchcock Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing elective surgery with planned utilization of invasive arterial pressure monitoring.

Description

Inclusion Criteria:

• Adults (18yr and older)
• Undergoing a planned (non-emergent, non-urgent) surgical procedure at DHMC for which an invasive arterial pressure monitor is standard clinical practice. Typical surgical procedures include but are not limited to craniotomy, thoracic surgery, abdominal surgery, and others.

Exclusion Criteria:

• Morbid obesity (BMI >40)
• Radial artery depth > 1cm from skin at location of sensor
• Peripheral vascular disease
• Atrial fibrillation
• Sensitivity or allergy to silicone or medical adhesive tape
• Inability to consent.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial Blood Pressure Measurement from Arterial Line	We will be capturing arterial blood pressure measurement per standard of care from arterial line. This will include systolic and diastolic measurements and will be sampled continuously from standard invasive monitoring equipment. Because of the high frequency sampling, we will be capturing the entire pulse waveform with each heartbeat.	Surgery start to surgery stop
Arterial Blood Pressure Measurement from Non Invasive Sensor	The piezoelectric sensor array detects mechanical pressure from the radial artery that is transmitted to the skin and converts this to microvolt electric potentials. These microvolt signals are captured by the sensor array equipment. The microvolt signals will be time-synchronized with the standard of care invasive arterial line pressure data.	Surgery start to surgery stop

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of accuracy of algorithm to convert piezoelectric signal data into blood pressure measurements.	Approximately 80% of the data collected in this study will be used to refine and train an algorithm which has previously been validated on phantom and swine models to convert piezoelectric sensor data into meaningful blood pressure measurements. The remaining data (approximately 20%) will be used to test the accuracy of the algorithm against actual measured invasive blood pressure. Accuracy will be measured in terms of +/- mmHg at diastolic and systolic pressures.	Approximately 4 months following collection of data from subjects

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: Dartmouth College
• Investigators: Principal Investigator: Alexander T Abess, MD, Dartmouth-Hitchcock Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Actual): October 30, 2023
• Study Completion (Actual): October 30, 2023

Study Registration Dates

• First Submitted: January 3, 2023
• First Submitted That Met QC Criteria: January 15, 2023
• First Posted (Actual): January 19, 2023

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Monitoring; Blood Pressure; Non-invasive; Piezoelectric; Array Sensor; Arterial Line
• Other Study ID Numbers: STUDY02001549

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No