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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

NCT ID: NCT00735631

Last Updated: 2011-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease

Keywords

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

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

Group Type EXPERIMENTAL

SISO model-based predictive closed-loop system

Intervention Type DEVICE

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

Interventions

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SISO 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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Agentschap voor Innovatie door Wetenschap en Technologie

OTHER

Sponsor Role collaborator

University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michel Struys, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Annick De Wolf, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Johan Decruyenaere, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UIniversity Hospital Ghent

Locations

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University Hospital Ghent

Ghent, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type DERIVED
PMID: 30311073 (View on PubMed)

Related Links

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http://www.uzgent.be

Website of the University Hospital Ghent

Other Identifiers

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2007/489

Identifier Type: -

Identifier Source: org_study_id