Non Invasive Continuous Blood Pressure Sensor

NCT05689294 | Completed

• 1 other identifier: STUDY02001549
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure; Arterial Line; Anesthesia

Keywords

Piezoelectric; Array Sensor; Blood Pressure; Monitoring; Arterial Line; Non-invasive

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

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

  Approximately 4 months following collection of data from subjects

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Dartmouth College: collaborator

Study Sites (1)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Study Officials

• Alexander T Abess, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology, Geisel School of Medicine, Dartmouth

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: January 19, 2023
• Study Start: April 1, 2023
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)