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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00789412
Recruitment Status : Completed
First Posted : November 11, 2008
Last Update Posted : October 28, 2009
Information provided by:
University of Schleswig-Holstein

Brief Summary:
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 or disease
Analgesia Sedation Mechanical Ventilation Pain Stress Intensive Care Unit Critical Care

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.

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: SSI for Monitoring of Analgesia and Sedation in Critically Ill Patients
Study Start Date : August 2008
Actual Primary Completion Date : August 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Inclusion Criteria:

  • analgosedated, mechanically ventilated patients on the ICU

Exclusion Criteria:

  • neurological disorder
  • age under 18
  • lack of sinus rhythm

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00789412

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

Responsible Party: Berthold Bein, UKSH, Campus Kiel Identifier: NCT00789412     History of Changes
Other Study ID Numbers: SSI-154-01
First Posted: November 11, 2008    Key Record Dates
Last Update Posted: October 28, 2009
Last Verified: October 2009

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

Additional relevant MeSH terms:
Critical Illness
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Disease Attributes
Pathologic Processes