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

Intraoperative Hypotension Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03795831
Study type Observational [Patient Registry]
Source Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Contact D.P. Veelo, Dr
Phone 0031205662533
Email d.p.veelo@amc.uva.nl
Status Recruiting
Phase
Start date March 1, 2017
Completion date December 30, 2019
View Details
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