Evaluation of an Active Decision Support System for Hemodynamic Optimization During High Risk Vascular Surgery

Study Overview
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Brief Summary
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Rivers et al. laid the foundation for modern hemodynamic and fluid management by establishing goal directed therapy (GDT) for the treatment of sepsis using fluid and inotropic and vasoactive agents. There have been many subsequent protocols to improve outcome in the operating room or in the ICU. These are mainly passive decision support systems. Active clinical decision support systems using fluid and pharmacologic agents to improve intraoperative hemodynamics are not really found. The investigators developed an active clinical decision support system based on an institutional GDT-protocol using fluid, vasopressors and inotropes using the LiDCOrapid device. The goal of the study was to check the feasibility of an active clinical decision support system to optimize hemodynamics during high risk vascular surgery based on the principles of GDT implementing fluid, vasopressors and inotropes.

Official Title
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Evaluation of an Active Decision Support System for Hemodynamic Optimization During High Risk Vascular Surgery

Conditions
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Feasibility, Active Decision Support System, Goal Directed Therapy

Intervention / Treatment
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* Other: active decision support system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: elective major vascular surgery such as peripheral arterial surgery and open abdominal aortic surgery except for carotid artery surgery Exclusion Criteria: patients under 18 years of age absence of cardiac sinus rhythm at induction of anesthesia

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: active decision support system (GDT protocol)<br>The active decision support system in this study is a goal directed therapy (GDT) protocol where threshold hemodynamic values are defined when to give fluid, vasopressors and inotropes. Hemodynamic values are measured with the LiDCOrapid device, which uses pulse contour analysis to continuously monitor cardiac output and respiratory variations in stroke volume (SVV). | Other: active decision support system<br>* The active decision support system in this study is a goal directed therapy (GDT) protocol where threshold hemodynamic values are defined when to give fluid, vasopressors and inotropes. Hemodynamic values are measured with the LiDCOrapid device, which uses pulse contour analysis to continuously monitor cardiac output and respiratory variations in stroke volume (SVV).<br>* Other names: goal directed therapy (GDT) protocol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of interventions done according to the active decision support system (GDT protocol) | The number of interventions done according to the active decision support system (GDT protocol) is calculated. | through study completion, an average of 6 months | 
| duration of use of active decision support system | The absolute duration of use and relative duration of use (in relation to the duration of surgery) of the active decision support system are calculated. | through study completion, an average of 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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active decision support system, goal directed therapy, Lidco, vascular surgery, hemodynamic optimization