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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Intraoperative Hypotension

Intervention / Treatment
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* Device: ClearSight feasibility testing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort<br>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<br>* 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<br>|

What is the study measuring?
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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 |