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Clinical Trials/NCT00735631
NCT00735631CompletedPhase 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.

University Hospital, Ghent1 site in 1 country36 target enrollmentStarted: June 1, 2008Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
36
Locations
1
Primary Endpoint
The propofol and remifentanil dose needed to keep the BIS within the target range
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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

Intervention: SISO model-based predictive closed-loop system (Device)

Outcomes

Primary Outcomes

The propofol and remifentanil dose needed to keep the BIS within the target range

Time Frame: During sedation

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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