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

Coronary Artery Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00735631
• Other study ID #: 2007/489
• Status: Completed
• Phase: Phase 4
• First received: August 14, 2008
• Last updated: December 6, 2011
• Start date: June 2008
• Est. completion date: October 2009

Study information

• Verified date: December 2011
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: October 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	Agentschap voor Innovatie door Wetenschap en Technologie

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The propofol and remifentanil dose needed to keep the BIS within the target range		During sedation	No
Secondary	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	No

External Links

•   Website of the University Hospital Ghent