Non Invasive Continuous Blood Pressure Sensor

Anesthesia Clinical Trial

Official title:

Piezoelectric Sensors for Non-invasive Continuous Arterial Blood Pressure Measurements

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05689294
• Other study ID #: STUDY02001549
• Status: Completed
• Start date: April 1, 2023
• Est. completion date: October 30, 2023

Study information

• Verified date: November 2023
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Arterial Line
• Blood Pressure

Locations

Country	Name	City	State
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	Dartmouth College

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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