search
Back to results

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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
SISO model-based predictive closed-loop system
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Patients entering the post-operative cardiac intensive care unit following coronary artery reconstruction surgery.

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Ghent

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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 %

Full Information

First Posted
August 14, 2008
Last Updated
December 6, 2011
Sponsor
University Hospital, Ghent
Collaborators
Agentschap voor Innovatie door Wetenschap en Technologie
search

1. Study Identification

Unique Protocol Identification Number
NCT00735631
Brief 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
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 Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
Agentschap voor Innovatie door Wetenschap en Technologie

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Patients entering the post-operative cardiac intensive care unit following coronary artery reconstruction surgery.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
The single-input-single-output (SISO) model-based predictive closed-loop system will be used to guide patient-individualized ICU sedation with propofol
Intervention Type
Device
Intervention Name(s)
SISO model-based predictive closed-loop system
Intervention Description
The single-input-single-output (SISO) model-based predictive closed-loop system will be used to guide patient-individualized ICU sedation with propofol
Primary Outcome Measure Information:
Title
The propofol and remifentanil dose needed to keep the BIS within the target range
Time Frame
During sedation
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel Struys, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Annick De Wolf, MD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Johan Decruyenaere, MD, PhD
Organizational Affiliation
UIniversity Hospital Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
30311073
Citation
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.
Results Reference
derived
Links:
URL
http://www.uzgent.be
Description
Website of the University Hospital Ghent

Learn more about this trial

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

We'll reach out to this number within 24 hrs