Clinical trial NCT05689294: Non Invasive Continuous Blood Pressure Sensor
Official title: Piezoelectric Sensors for Non-invasive Continuous Arterial Blood Pressure Measurements
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Pressure
Arterial Line
Anesthesia
Keywords: Piezoelectric
Array Sensor
Blood Pressure
Monitoring
Arterial Line
Non-invasive
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Dartmouth College
First posted: 2023-01-19
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients undergoing elective surgery with planned utilization of invasive arterial pressure monitoring.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Arterial Blood Pressure Measurement from Arterial Line
timeFrame: Surgery start to surgery stop
measure: Arterial Blood Pressure Measurement from Non Invasive Sensor
timeFrame: Surgery start to surgery stop
Secondary outcomes:
measure: Assessment of accuracy of algorithm to convert piezoelectric signal data into blood pressure measurements.
timeFrame: Approximately 4 months following collection of data from subjects
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Alexander T Abess, MD
role: PRINCIPAL_INVESTIGATOR
References: