Evaluation of the Accuracy, Safety and Robustness of a Single-input-single-output (SISO) Model-ba… (NCT00735631) | Clinical Trial Compass
CompletedPhase 4
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
Belgium36 participantsStarted 2008-06
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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
What they're measuring
1
The propofol and remifentanil dose needed to keep the BIS within the target range