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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: SISO model-based predictive closed-loop system

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • University Hospital Ghent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The propofol and remifentanil dose needed to keep the BIS within the target range	During sedation

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: 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

Publications and helpful links

General Publications

• 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.

Helpful Links

• Website of the University Hospital Ghent

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: August 14, 2008
• First Submitted That Met QC Criteria: August 14, 2008
• First Posted (Estimate): August 15, 2008

Study Record Updates

• Last Update Posted (Estimate): December 7, 2011
• Last Update Submitted That Met QC Criteria: December 6, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: Patients entering the post-operative cardiac intensive care unit following coronary artery reconstruction surgery.
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: 2007/489