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| Name | Class |
|---|---|
| Agentschap voor Innovatie door Wetenschap en Technologie | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | The single-input-single-output (SISO) model-based predictive closed-loop system will be used to guide patient-individualized ICU sedation with propofol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SISO model-based predictive closed-loop system | Device | The single-input-single-output (SISO) model-based predictive closed-loop system will be used to guide patient-individualized ICU sedation with propofol |
| Measure | Description | Time Frame |
|---|---|---|
| The propofol and remifentanil dose needed to keep the BIS within the target range | During sedation |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michel Struys, MD, PhD | University Hospital, Ghent | Principal Investigator |
| Annick De Wolf, MD | University Hospital, Ghent | Principal Investigator |
| Johan Decruyenaere, MD, PhD | UIniversity Hospital Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ghent | Ghent | 9000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30311073 | Derived | Neckebroek M, Ionescu CM, van Amsterdam K, De Smet T, De Baets P, Decruyenaere J, De Keyser R, Struys MMRF. A comparison of propofol-to-BIS post-operative intensive care sedation by means of target controlled infusion, Bayesian-based and predictive control methods: an observational, open-label pilot study. J Clin Monit Comput. 2019 Aug;33(4):675-686. doi: 10.1007/s10877-018-0208-2. Epub 2018 Oct 11. |
| Label | URL |
|---|---|
| Website of the University Hospital Ghent | View source |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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