Non-Invasive Blood Pressure Monitoring

Non-invasive Hemodynamic Monitoring With ClearSight in Patients Undergoing Elective Cardiac or Neurointerventional Surgery: A Prospective Observational Cohort Study

The purpose of this study is to evaluate an alternative way of continuously measuring blood pressure in patients coming for complex surgery. The investigators will directly compare the speed of set up and accuracy of the new ClearSight monitor to those taken by the arterial line monitor, which is the current gold standard for recording blood pressure measurements.

Study Overview

• Status: Recruiting
• Conditions: Blood Pressure
• Intervention / Treatment: Device: ClearSight System

Detailed Description

Continuous invasive arterial line monitoring is the most accurate way to monitor a patient's hemodynamics. Being able to rapidly detect a spike or drop in blood pressure is crucial in the care of both surgical and critically ill patients. Major fluctuations in blood pressure have been associated with bleeding, cardiac damage, cognitive dysfunction, stroke, and acute kidney injury. The impact of poor blood pressure control on patient outcomes is influenced not only by how high or low the pressure gets, but how long it remains at those extremes. The alternative to continuous blood pressure monitoring is to use intermittent non-invasive blood pressure cuffs, which typically display a blood pressure measurement every 5 minutes when being used in the operating room. While this might be sufficient for routine, short surgeries and monitoring in stable patients, blood pressure cuffs are inadequate for patients who are unstable or undergoing extensive surgery.

An arterial line monitor involves the insertion of a catheter into the radial artery and allows for the beat by-beat monitoring of blood pressure. The insertion of this monitor is painful, time consuming, and puts the patient at risk of infection, bleeding, nerve injury, and damage to the artery. There are many factors that can complicate the insertion of the arterial line including the presence of peripheral vascular disease, small arteries, large body habitus, and poor patient cooperation. In view of these problems, researchers have investigated non-invasive monitoring systems as alternatives to invasive arterial cannulation, but these data are limited and inconsistent.

A alternative device called the ClearSight monitor, produced by Edwards LifeSciences, provides continuous noninvasive blood pressure monitoring. The ClearSight monitor connects to the patient by wrapping an inflatable cuff around their finger. It will detect the blood volume fluctuations in the finger that occur with each heartbeat. It then converts that volume change data into beat-by-beat hemodynamic information, including blood pressure, mean arterial pressure, cardiac output, stroke volume and stroke volume variation. The ClearSight monitor was developed to advance hemodynamic monitoring of moderate-to high-risk surgery patients, including elderly and obese patients.

Patients receiving elective cardiac or cerebrovascular disease are an ideal population to study. These patients require continuous blood pressure monitoring to prevent radical swings in blood pressure (either high or low), which can put the patient at risk of intracranial hemorrhage and increased intracranial pressure, or tissue ischemia, respectively. In addition, these patients frequently have many comorbid conditions including coronary artery disease, congestive heart failure, peripheral vascular disease, cerebrovascular disease, dementia, chronic obstructive pulmonary disease, hypertension, liver disease, renal disease, obesity, malignancy, and diabetes. Many of these health conditions may compromise and affect ClearSight system's ability to analyze blood pressure. For example, peripheral vascular disease, diabetes, and hypertension can cause arterial damage, arterial stenosis and reduced blood flow to the hands and feet. Consequently, it will be informative to test the ClearSight's accuracy in this medically challenging patient demographic.

The current standard of care for patients coming for elective cardiac or neurointerventional procedures at Royal University Hospital is an invasive arterial cannulation. The purpose of this study is to compare the systolic blood pressure, diastolic blood pressure, and mean arterial blood pressure measured by the non-invasive blood pressure monitor (ClearSight) versus the invasive radial arterial cannulation in these patients.

• Study Type: Observational
• Enrollment (Estimated): 62

Contacts and Locations

• Study Contact: Name: Peter Hedlin, PhD MD FRCPC; Phone Number: 306-655-1183; Email: peter.hedlin@usask.ca

Study Locations

• Canada
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 0W8
      • Recruiting
      • Royal University Hospital
      • Contact: Peter Hedlin, PhD MD FRCPC; Phone Number: 306-655-1183; Email: peter.hedlin@usask.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

These participants are receiving either elective cardiac surgery or elective neurointerventional surgery at the Royal University Hospital, Saskatoon.

Description

Inclusion Criteria:

• written informed consent
• undergoing elective cardiac surgery OR elective neurointerventional surgery (with standard arterial radial line for continuous blood pressure monitoring)

Exclusion Criteria:

• undergoing emergent cardiac surgery OR emergent neurointerventional surgery

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Elective Cardiac Surgery Patients; Patients having elective cardiac surgery, who have given written consent, will have the ClearSight device, along with the standard radial arterial line.	Device: ClearSight System; Patients having either elective cardiac surgery or elective neurointerventional surgery will have blood pressure monitored by the ClearSight device, along with the standard of care radial arterial line, throughout their surgery. The arterial line will be placed on the radial artery contralateral to the upper arm blood pressure cuff. The ClearSight device will then be placed on the third finger of the hand ipsilateral to the radial arterial line.
Elective Neurointerventional Surgery Patients; Patients having elective neurointerventional surgery, who have given written consent, will have the ClearSight device, along with the standard radial arterial line.	Device: ClearSight System; Patients having either elective cardiac surgery or elective neurointerventional surgery will have blood pressure monitored by the ClearSight device, along with the standard of care radial arterial line, throughout their surgery. The arterial line will be placed on the radial artery contralateral to the upper arm blood pressure cuff. The ClearSight device will then be placed on the third finger of the hand ipsilateral to the radial arterial line.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
systolic blood pressure (SBP), diastolic blood pressure (DBP) and mean arterial pressure (MAP)	compare differences in blood pressure parameters (SBP, DBP, MAP) collected by ClearSight system versus gold standard (radial arterial line)	duration of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time to place instrument	compare time to place the radial arterial line, and ClearSight finger cuff and wrist strap	before surgery

Collaborators and Investigators

• Sponsor: University of Saskatchewan
• Investigators: Principal Investigator: Peter Hedlin, PhD MD FRCPC, University of Saskatchewan

Publications and helpful links

General Publications

• Rogge DE, Nicklas JY, Schon G, Grothe O, Haas SA, Reuter DA, Saugel B. Continuous Noninvasive Arterial Pressure Monitoring in Obese Patients During Bariatric Surgery: An Evaluation of the Vascular Unloading Technique (Clearsight system). Anesth Analg. 2019 Mar;128(3):477-483. doi: 10.1213/ANE.0000000000003943.
• Dahan A, Engberts DP, Niesters M. Arterial Line Placement: Safety First. Anesthesiology. 2016 Mar;124(3):528-9. doi: 10.1097/ALN.0000000000000968. No abstract available.

Helpful Links

• ClearSight monitor, Edwards LifeSciences

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: April 11, 2023
• First Submitted That Met QC Criteria: April 11, 2023
• First Posted (Actual): April 24, 2023

Study Record Updates

• Last Update Posted (Actual): May 11, 2025
• Last Update Submitted That Met QC Criteria: May 6, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: USask-1795

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
• product manufactured in and exported from the U.S.: No