Blood PressureNCT05825937
Non-Invasive Blood Pressure Monitoring
An observational study of Blood Pressure, run by University of Saskatchewan at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Pressure
- What is being tested?
- ClearSight System
- Type of treatment
- Medical device
- How many people
- 62 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2021to 31 Dec 2025
- How long will I take part?
- 3 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: These participants are receiving either elective cardiac surgery or elective neurointerventional surgery at the Royal University Hospital, Saskatoon.
Who may be able to join
- written informed consent
- undergoing elective cardiac surgery OR elective neurointerventional surgery (with standard arterial radial line for continuous blood pressure monitoring)
Who cannot join
- undergoing emergent cardiac surgery OR emergent neurointerventional surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8
Peter Hedlin, PhD MD FRCPC, 306-655-1183, peter.hedlin@usask.ca
About this study
Official title: 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.
Read the 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.
- Conditions
- Blood Pressure
- Being tested
- ClearSight System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClearSight SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: ClearSight System | |
| 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. Receives: Device: ClearSight System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: duration of surgery
Secondary outcomes (1)
time to place instrument
compare time to place the radial arterial line, and ClearSight finger cuff and wrist strap
Measured: before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start1 Jun 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (estimated)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Hedlin, University of Saskatchewan
- Investigators
- Peter Hedlin, PhD MD FRCPC, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05825937
- Sponsor's protocol ID
- USask-1795
- Status last verified
- Jan 2025
- First submitted
- 11 Apr 2023
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30649073Dahan 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.
PubMed 26606174Goncin U, Liu KK, Rawlyk B, Dalkilic S, Walker MEJ, Norton J, Hedlin P. Comparison of the ClearSight finger cuff monitor versus invasive arterial blood pressure measurement in elective cardiac surgery patients: a prospective observational study. Can J Anaesth. 2024 Nov;71(11):1495-1504. doi: 10.1007/s12630-024-02834-x. Epub 2024 Sep 24.
PubMed 39317830
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Hemodynamic Monitoring With ClearSight in Patients Undergoing Elective Cardiac or Neurointerventional Surgery: A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT05825937
- Acronym / sponsor ID
- USask-1795
- Conditions
- Blood Pressure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elective Cardiac Surgery Patients | – | Device: ClearSight SystemPatients having elective cardiac surgery, who have given written consent, will have the ClearSight device, along with the standard radial arterial line. |
| Elective Neurointerventional Surgery Patients | – | Device: ClearSight SystemPatients having elective neurointerventional surgery, who have given written consent, will have the ClearSight device, along with the standard radial arterial line. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- These participants are receiving either elective cardiac surgery or elective neurointerventional surgery at the Royal University Hospital, Saskatoon.
Key inclusion criteria (2 listed)
- written informed consent
- undergoing elective cardiac surgery OR elective neurointerventional surgery (with standard arterial radial line for continuous blood pressure monitoring)
Key exclusion criteria (1 listed)
- undergoing emergent cardiac surgery OR emergent neurointerventional surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClearSight SystemPatients 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. | Device | Elective Cardiac Surgery Patients, Elective Neurointerventional Surgery Patients |
Primary outcome
systolic blood pressure (SBP), diastolic blood pressure (DBP) and mean arterial pressure (MAP)
Time frame: duration of surgery
compare differences in blood pressure parameters (SBP, DBP, MAP) collected by ClearSight system versus gold standard (radial arterial line)
1 secondary outcome
time to place instrument
Time frame: before surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Background: PubMed 30649073Rogge 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.
- Background: PubMed 26606174Dahan 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.
- Derived from this study: PubMed 39317830Goncin U, Liu KK, Rawlyk B, Dalkilic S, Walker MEJ, Norton J, Hedlin P. Comparison of the ClearSight finger cuff monitor versus invasive arterial blood pressure measurement in elective cardiac surgery patients: a prospective observational study. Can J Anaesth. 2024 Nov;71(11):1495-1504. doi: 10.1007/s12630-024-02834-x. Epub 2024 Sep 24.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter Hedlin, PhD MD FRCPC principal investigator
University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure, run by University of Saskatchewan at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Hedlin, PhD MD FRCPC (306-655-1183, peter.hedlin@usask.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
systolic blood pressure (SBP), diastolic blood pressure (DBP) and mean arterial pressure (MAP) (time frame: duration of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05825937, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.