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

Conditions

Intraoperative Hypotension

Brief summary

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.

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.

Santino R. Rellum, Sijm H. Noteboom, Björn J. P. van der Ster, Jaap Schuurmans, Eline Kho et al. (8 authors)

European Journal of Anaesthesiology2025-02-2712 citations

10.1097/eja.0000000000002150

A comparison between invasive and noninvasive measurement of the Hypotension Prediction Index

Santino R. Rellum, Eline Kho, Jimmy Schenk, Björn J. P. van der Ster, Alexander P. J. Vlaar et al. (6 authors)

European Journal of Anaesthesiology2024-10-164 citations

10.1097/eja.0000000000002082

Clinical agreement of a novel algorithm to estimate radial artery blood pressure from the non-invasive finger blood pressure

Eline Kho, Björn J. P. van der Ster, Ward H. van der Ven, Alexander P. J. Vlaar, Rogier V. Immink et al. (6 authors)

Journal of Clinical Anesthesia2022-09-2618 citations

10.1016/j.jclinane.2022.110976

Interventions

DEVICEClearSight 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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

Netherlands

Contacts

Primary ContactD.P. Veelo, Dr

d.p.veelo@amc.uva.nl0031205662533

Outcome results

None listed