Comparative Noninvasive Continuous Cardiac Output by the Clearsight With Invasive Monitoring by Pulsioflex in Abdominal Surgery

Study Overview
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Brief Summary
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In high-risk patients, it is now recommended to guide the intraoperative volume replacement via the stroke volume. Today, the most commonly used technique for estimating the stroke volume is the arterial waveform analysis in the radial artery. This technique has the disadvantage of being invasive and increasing the time dedicated to anesthesia during the surgery. The future is the non-invasive monitoring of stroke volume. Thus, Edwards Life Science has developed a continuous monitoring technology and non-invasive arterial pressure, cardiac output and stroke volume using a digital sensor (ClearSight®). The continuous monitoring of blood pressure by this technique was validated in cardiothoracic surgery but studies about monitoring cardiac output or stroke volume are inconclusive and contradictory. The objective of this study is to compare the use of non-invasive monitoring of stroke volume by Clearsight® with the arterial waveform analysis in the radial artery by Pulsioflex® in major surgery.

Official Title
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Comparative Noninvasive Continuous Cardiac Output by the Clearsight With Invasive Monitoring by Pulsioflex in Abdominal Surgery

Conditions
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Cardiac Output Measurement

Intervention / Treatment
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* Device: Cardiac output and stroke ejection volume monitoring with arterial waveform analysis in the digital artery (ClearSight®)
* Device: Cardiac output and stroke ejection volume monitoring with arterial waveform analysis in the radial artery (Pulsioflex®).


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled to undergo major surgery Patients monitored by a Pulsioflex® device Exclusion Criteria: Patients with heart rhythm disorder Patients with Raynaud's disease or vasculitis Emergency surgery Significant edema fingers

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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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Cardiac output and stroke ejection volume monitoring with arterial waveform analysis in the digital artery (ClearSight®)|nan|
|Device: Cardiac output and stroke ejection volume monitoring with arterial waveform analysis in the radial artery (Pulsioflex®).|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke Ejection Volume (SEV) measure by ClearSight® |  | 24 hours | 
| Stroke Ejection Volume (SEV) measure by Pulsioflex® |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Output (CO) measure by ClearSight® |  | 24 hours | 
| Cardiac Output (CO) measure by Pulsioflex® |  | 24 hours | 
| Stroke Ejection Volume Variations (SVV) measure by ClearSight® |  | 24 hours | 
| Stroke Ejection Volume Variations (SVV) measure by Pulsioflex® |  | 24 hours |