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Completed

NCT Number: NCT05689294

Non Invasive Continuous Blood Pressure Sensor

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.

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Key information

Conditions

Blood Pressure Anesthesia Arterial Line

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Arterial Blood Pressure Measurement from Arterial Line

    Time frame: Surgery start to surgery stop

    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.

  2. Arterial Blood Pressure Measurement from Non Invasive Sensor

    Time frame: Surgery start to surgery stop

    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.

Secondary outcomes

  1. Assessment of accuracy of algorithm to convert piezoelectric signal data into blood pressure measurements.

    Time frame: Approximately 4 months following collection of data from subjects

    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.

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • Dartmouth College

Registry information

Official study title

Piezoelectric Sensors for Non-invasive Continuous Arterial Blood Pressure Measurements

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 19, 2023
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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