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

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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00735631

Enrollment

Registered

2008-08-15

Start date

2008-06-30

Completion date

2009-10-31

Last updated

2011-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Patients entering the post-operative cardiac intensive care unit following coronary artery reconstruction surgery.

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.

Interventions

DEVICESISO model-based predictive closed-loop system

The single-input-single-output (SISO) model-based predictive closed-loop system will be used to guide patient-individualized ICU sedation with propofol

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The propofol and remifentanil dose needed to keep the BIS within the target range	During sedation

Secondary

Measure	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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026