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

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?

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Key information

Conditions

Analgesia Agnosia Critical Care Critical Illness Disease Attributes Intensive Care Unit Mechanical Ventilation Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Sedation Signs and Symptoms Stress

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Kiel, 24106, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

analgosedated, mechanically ventilated patients on the ICU

Exclusion criteria

neurological disorder
age under 18
lack of sinus rhythm

Sponsors and collaborators

Lead sponsor

University Hospital Schleswig-Holstein

Other

Registry information

Official study title

SSI for Monitoring of Analgesia and Sedation in Critically Ill Patients

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Nov 11, 2008
Registry last updated: Oct 28, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed