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

• Conditions: Intraoperative Hypotension
• Interventions: Device: ClearSight feasibility testing

• Registration Number: NCT03795831
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Study Timeline

• Study Start: 2017-03-01
• Status Verified: 2019-01
• Study First Submitted: 2019-01-04
• Study First Submitted QC: 2019-01-04
• Study First Posted: 2019-01-08
• Last Update Submitted: 2019-01-08
• Last Update Posted: 2019-01-10
• Primary Completion: 2019-12-30
• Study Completion: 2019-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort	ClearSight feasibility testing	Adult patients, undergoing surgery requiring general anesthesia, planned to be monitored with a system that accurately measures and stores the intra-arterial waveform.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Academic Medical Center; 🇳🇱 Amsterdam, Netherlands