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

NCT ID: NCT00789412

Last Updated: 2009-10-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2009-10-31

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?

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.

Conditions

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Expected ICU

Patients with expected postoperative admission to the ICU. Baseline measurement of SSI. Exploration prior to weaning.

No interventions assigned to this group

Unexpected ICU

Patients with unexpected stay at the ICU. No baseline measurement of SSI. Exploration in 'steady state' of analgosedation.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• analgosedated, mechanically ventilated patients on the ICU

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Schleswig-Holstein

OTHER

Sponsor Role: lead

Responsible Party

UKSH, Campus Kiel

Principal Investigators

Jens Scholz, Prof Dr med

Role: STUDY_CHAIR

Institut für Anästhesiologie und Operative Intensivmedizin, Universitätsklinik Schleswig-Holstein, Campus Kiel

Locations

Institut für Anästhesiologie und Operative Intensivmedizin, Universitätsklinik Schleswig-Holstein, Campus Kiel

Kiel, , Germany

Countries

Germany

Other Identifiers

SSI-154-01

Identifier Type: -

Identifier Source: org_study_id