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

NCT00735631 | Completed Phase 4

• 1 other identifier: 2007/489
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Patients entering the post-operative cardiac intensive care unit following coronary artery reconstruction surgery.

Outcome Measures

Primary Outcomes (1)

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

  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 %

  During sedation

Study Arms (1)

1

EXPERIMENTAL

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

Interventions

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

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients in the immediate post-operative phase after an coronary artery reconstruction surgery.
• age \>= 18 years
• informed consent obtained before the surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Agentschap voor Innovatie door Wetenschap en Technologie: collaborator

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Publications (1)

• 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.

  PMID: 30311073 DERIVED

Related Links

• Website of the University Hospital Ghent

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2008
• First Posted: August 15, 2008
• Study Start: June 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: October 1, 2009
• Last Updated: December 7, 2011

Record last verified: 2011-12

Locations

BE (1)