Evaluation of the Accuracy, Safety and Robustness of a Single-input-single-output (SISO) Model-based Predictive Closed-loop System to Guide Patient-individualized ICU Sedation

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the accuracy, safety and robustness of a single-input-single output (SISO) model-based predictive closed-loop system to guide patient-individualized ICU sedation.

Official Title
-----------------
Evaluation of the Accuracy, Safety and Robustness of a Single-input-single-output (SISO) Model-based Predictive Closed-loop System to Guide Patient-individualized ICU Sedation.

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Device: SISO model-based predictive closed-loop system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients in the immediate post-operative phase after an coronary artery reconstruction surgery. age >= 18 years informed consent obtained before the surgery Exclusion Criteria: severe renal failure defined by the RIFLE Classification levels Risk, Failure and End-stage Kidney Failure severe hepatic failure defined by a bilirubin level of >= 3 mg/dl and/or a prothrombin level of < 50% before the surgery low ejection fraction defined as < 40% age < 18 years postoperative bleeding so that a new surgery is necessary history of cardiovascular accident (CVA) history of COPD age > 75 years postoperative cardiac index < 2.2 for more than 2 hours SvO2 < 60% for more than 2 hours hypotension with a MAP < 60 mmHg for more than 2 hours sedation agents other than remifentanyl and propofol including also Catapressan, Risperdal, Etumine Remifentanyl dose exceeding 0.5 µg/kg/min. absence of informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>The single-input-single-output (SISO) model-based predictive closed-loop system will be used to guide patient-individualized ICU sedation with propofol | Device: SISO model-based predictive closed-loop system<br>* The single-input-single-output (SISO) model-based predictive closed-loop system will be used to guide patient-individualized ICU sedation with propofol<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The propofol and remifentanil dose needed to keep the BIS within the target range |  | During sedation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The hemodynamic stability of the patient, being defined as: - mean arterial blood pressure between 65 and 85 - heart rate around 80 beats'/min - diuresis 0.5 - 1 ml/kg/hour - normal pH - normal cardiac index as defined by a CI > 2.2 - Sv02 > 60 % |  | During sedation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patients entering the post-operative cardiac intensive care unit following coronary artery reconstruction surgery.