Validation Study in Patients of a Non-invasive Blood Pressure Monitor for Perioperative Use

Collecting all available data (waveforms, beat to beat data, status data) generated by a non invasive blood pressure monitor on each hand and compare this to the actual data obtained by intra arterial (radial) monitoring.

This to see if the non invasive bloodpressure monitor can be validated for intraoperative use.

Study Overview

• Status: Unknown
• Conditions: Intraoperative Hypotension
• Intervention / Treatment: Device: ClearSight feasibility testing

Detailed Description

Although a blood pressure monitoring device could be evaluated by the comparing systolic, diastolic and mean arterial pressure to a reference pressure, it is the specific aim to collect all available data (waveforms, beat to beat data, status data) generated by the blood pressure monitor.

After data analysis and comparison to patient's actual intra-arterial waveform, the outcome will be evaluated by Association for the Advancement of Medical Instrumentation (AAMI) standards to see if the non invasive bloodpressure monitor can be validated for intraoperative use.

The study is targeted at patients already monitored with a system that accurately measures and stores the intra-arterial waveform, such as the FloTrac system in the EV1000 monitor.

This study is a substudy of a feasability protocol evaluating a new algorithm for the Clearsight system.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: D.P. Veelo, Dr; Phone Number: 0031205662533; Email: d.p.veelo@amc.uva.nl

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1105AZ
    • Recruiting
    • Academic Medical Center
    • Contact: D.P. Veelo, Dr.; Phone Number: 0031205662533; Email: d.p.veelo@amc.uva.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients in a perioperative setting already monitored with a system that accurately measures and stores the intra-arterial waveform, such as the FloTrac system in the EV1000 monitor.

Description

Inclusion Criteria:

• Patients whose arterial blood pressure is measured invasively with technology that allows for the storage of the intra-arterial waveform with sufficient quality and resolution (Flotrac).
• Patients older than 18, for elective general surgery.

Exclusion Criteria:

- Patient conditions that are expected to potentially and significantly affect the transfer of pressure between radial artery and the finger, e.g. due to recent finger fractures

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort; Adult patients, undergoing surgery requiring general anesthesia, planned to be monitored with a system that accurately measures and stores the intra-arterial waveform.	Device: ClearSight feasibility testing; A cuff is placed on a finger of the patient. The ClearSight system uses a volume clamp technology allowing measuring of continuous blood pressure waveform. Note: There will only be observational recordings, no interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
validation systole, diastole, mean ABP and pulse pressure	accuracy and precision of invasive blood pressure curve vs non-invasive blood pressure curves(ipsilateral and contralateral)	within 1 hour
implementation of software alterations to improve systole, diastole, mean ABP accuracy and pulse pressure	Comparison of the non-invasive blood pressure curve after software alterations to the reference and invasive arterial blood pressure curve	time during surgery

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Collaborators: Edwards Lifesciences
• Investigators: Principal Investigator: D.P. Veelo, Dr, inverstigator

Publications and helpful links

General Publications

• Kho E, van der Ster BJP, van der Ven WH, Vlaar APJ, Immink RV, Veelo DP. Clinical agreement of a novel algorithm to estimate radial artery blood pressure from the non-invasive finger blood pressure. J Clin Anesth. 2022 Dec;83:110976. doi: 10.1016/j.jclinane.2022.110976. Epub 2022 Sep 26.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Anticipated): December 30, 2019
• Study Completion (Anticipated): December 30, 2019

Study Registration Dates

• First Submitted: January 4, 2019
• First Submitted That Met QC Criteria: January 4, 2019
• First Posted (Actual): January 8, 2019

Study Record Updates

• Last Update Posted (Actual): January 10, 2019
• Last Update Submitted That Met QC Criteria: January 8, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: 2017-14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes