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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

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ClinicalTrials.gov Identifier: NCT00735631
Recruitment Status : Completed
First Posted : August 15, 2008
Last Update Posted : December 7, 2011
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: SISO model-based predictive closed-loop system Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : June 2008
Primary Completion Date : September 2009
Study Completion Date : October 2009
Arms and Interventions

Arm Intervention/treatment
Experimental: 1
The single-input-single-output (SISO) model-based predictive closed-loop system will be used to guide patient-individualized ICU sedation with propofol
Device: 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


Outcome Measures

Primary Outcome Measures :
  1. The propofol and remifentanil dose needed to keep the BIS within the target range [ Time Frame: During sedation ]

Secondary Outcome Measures :
  1. 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 % [ Time Frame: During sedation ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00735631


Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Agentschap voor Innovatie door Wetenschap en Technologie
Investigators
Principal Investigator: Michel Struys, MD, PhD University Hospital, Ghent
Principal Investigator: Annick De Wolf, MD University Hospital, Ghent
Principal Investigator: Johan Decruyenaere, MD, PhD UIniversity Hospital Ghent
More Information

Additional Information:
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00735631     History of Changes
Other Study ID Numbers: 2007/489
First Posted: August 15, 2008    Key Record Dates
Last Update Posted: December 7, 2011
Last Verified: December 2011

Keywords provided by University Hospital, Ghent:
Patients entering the post-operative cardiac intensive care unit following coronary artery reconstruction surgery.

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases