NCT00735631|CompletedPhase 4
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Sponsor study identifier
interventional
36
1 country
1
Study Start
June 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2009
Actual (reported)Study Completion
October 2009
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2008
Date type not reportedThis date has not been verified as actual or estimated.
August 14, 2008
Actual (reported)August 15, 2008
Actual (reported)September 2009
Actual (reported)October 2009
Actual (reported)The propofol and remifentanil dose needed to keep the BIS within the target range
During sedation
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
The single-input-single-output (SISO) model-based predictive closed-loop system will be used to guide patient-individualized ICU sedation with propofol
The single-input-single-output (SISO) model-based predictive closed-loop system will be used to guide patient-individualized ICU sedation with propofol
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University Hospital Ghent
Ghent, 9000, Belgium
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.
Michel Struys, MD, PhD
University Hospital, Ghent
Annick De Wolf, MD
University Hospital, Ghent
Johan Decruyenaere, MD, PhD
UIniversity Hospital Ghent
36 participants (actual enrollment reported by the registry).
First Submitted
August 14, 2008
First Posted
August 15, 2008
Study Start
June 2008
Date type not reportedThis date has not been verified as actual or estimated.
Randomized, Two-arm, Non-inferiority Study Comparing Endeavor-Resolute Stent With Abbot Xience-V Stent
Contact the study team to confirm eligibility.
Primary Completion
September 2009
Actual (reported)Study Completion
October 2009
Actual (reported)Last Updated
December 7, 2011
Record last verified: 2011-12
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Source: ClinicalTrials.gov.
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