Non-Invasive Blood Pressure Monitoring

NCT05825937 | Recruiting

• 1 other identifier: USask-1795
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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 standard for recording blood pressure measurements.

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• time to place instrument

  before surgery

Study Arms (2)

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

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

Interventions

ClearSight System DEVICE

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 Cardiac Surgery Patients; Elective Neurointerventional Surgery Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• undergoing emergent cardiac surgery OR emergent neurointerventional surgery

Sponsors & Collaborators

• University of Saskatchewan: lead

Study Sites (1)

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

RECRUITING

Related Publications (3)

• 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.

  PMID: 30649073 BACKGROUND

• 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.

  PMID: 26606174 BACKGROUND

• Goncin 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.

  PMID: 39317830 DERIVED

Study Officials

• Peter Hedlin, PhD MD FRCPC

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Hedlin, PhD MD FRCPC

CONTACT

306-655-1183; peter.hedlin@usask.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Scientist, Assistant Professor

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: April 24, 2023
• Study Start: June 1, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 11, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)