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Surgical Stress Index as a Tool for Monitoring Analgesia and/or Sedation in Critically Ill Patients

This study has been completed.
Sponsor:
Information provided by:
University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT00789412
First received: November 10, 2008
Last updated: October 27, 2009
Last verified: October 2009
History of Changes
  Purpose

The hypothesis of the study is: Does the Surgical Stress Index (SSI) correlate with the Behavioral Pain Scale (BPS), the Ramsay Sedation Scale (RSS)and/or the Behavioral Pain Scale(BPV) and can therefore be used to monitor the quality of analgosedation in noncommunicative intensive care unit patients?


Condition
Analgesia
Sedation
Mechanical Ventilation
Pain
Stress
Intensive Care Unit
Critical Care

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: SSI for Monitoring of Analgesia and Sedation in Critically Ill Patients

Resource links provided by NLM:

MedlinePlus related topics: Critical Care
U.S. FDA Resources

Further study details as provided by University of Schleswig-Holstein:

Estimated Enrollment: 60
Study Start Date: August 2008
Study Completion Date: October 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Expected ICU
Patients with expected postoperative admission to the ICU. Baseline measurement of SSI. Exploration prior to weaning.
Unexpected ICU
Patients with unexpected stay at the ICU. No baseline measurement of SSI. Exploration in `steady state` of analgosedation.

Detailed Description:

The Surgical Stress index (SSI) was developed as a bedside tool to measure `pain` during surgery. First trials showed a good correlation between SSI and aching procedures and a negative correlation to the dosage of Remifentanil. The first evaluation studies were performed under Propofol and Remifentanil anaesthesia. A different site of use for the Surgical Stress Index could be the intensive care medicine. `Analgesia and Sedation are essential elements of intensive care treatment and relevant for patient outcome... There is therefore a need to monitor and define the level of sedation and pain and to provide the critically ill patient with adequate analgesia and sedation.` (j. martin 2002). Although the Ramsey Sedation Scale was never proven for validity and reliability it is an often used score for measurement of sedation quality. (Ramsay 74, Hansen-Flaschen 94, Jacobi 02, Martin 04). The Behavioral Pain Scale showed , apart from systolic blood pressure and heart rate, to be reliable and valid for measuring pain in noncommunicative, mechanical ventilated intensive care unit patients. (Payen 01, Jacobi 02, Aissaoui 05) These scales need to be performed a few times a day to be up to date and therefore time consuming for the intensive care staff. The Surgical Stress Index could be a non-invasive, bedside and online tool for measurement of sedation and/or analgesia in this complex patient group.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

postoperative patients with admission to the intensive care unit who are intubated and mechanically ventilated

Criteria

Inclusion Criteria:

  • analgosedated, mechanically ventilated patients on the ICU

Exclusion Criteria:

  • neurological disorder
  • age under 18
  • lack of sinus rhythm
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00789412

Locations
Germany
Institut für Anästhesiologie und Operative Intensivmedizin, Universitätsklinik Schleswig-Holstein, Campus Kiel
Kiel, Germany, 24106
Sponsors and Collaborators
University of Schleswig-Holstein
Investigators
Study Chair: Jens Scholz, Prof Dr med Institut für Anästhesiologie und Operative Intensivmedizin, Universitätsklinik Schleswig-Holstein, Campus Kiel
  More Information

No publications provided

Responsible Party: Berthold Bein, UKSH, Campus Kiel
ClinicalTrials.gov Identifier: NCT00789412     History of Changes
Other Study ID Numbers: SSI-154-01
Study First Received: November 10, 2008
Last Updated: October 27, 2009
Health Authority: Germany: Ethics Commission

Keywords provided by University of Schleswig-Holstein:
Analgesia
Sedation
Critical Illness
Intensive Care

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013