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NCT Number: NCT00735631

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Ghent

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SISO model-based predictive closed-loop system

Device

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

Primary outcomes

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

    Time frame: During sedation

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • Agentschap voor Innovatie door Wetenschap en Technologie

Registry information

Official study 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.

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 15, 2008
Registry last updated
Dec 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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