NCT00789412

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 11, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

October 28, 2009

Status Verified

October 1, 2009

Enrollment Period

1 year

First QC Date

November 10, 2008

Last Update Submit

October 27, 2009

Conditions

AnalgesiaSedationMechanical VentilationPainStressIntensive Care UnitCritical Care

Keywords

AnalgesiaSedationCritical IllnessIntensive Care

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • analgosedated, mechanically ventilated patients on the ICU

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Kiel, 24106, Germany

Location

MeSH Terms

Conditions

AgnosiaPainCritical Illness

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Study Officials

  • Jens Scholz, Prof Dr med

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

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 10, 2008

First Posted

November 11, 2008

Study Start

August 1, 2008

Primary Completion

August 1, 2009

Study Completion

October 1, 2009

Last Updated

October 28, 2009

Record last verified: 2009-10

Locations

DE(1)