- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02663505
Development of an ICU Risk Score
I See You Risk Your ICU Capacity - Development Of An ICU Risk Score
Intensive care units are inevitable for high risk surgery and/or high risk patients i.e. patients with severe preconditions. However, usually the capacity of these units is limited such that at times elective surgery has to be postponed if there is no ICU capacity.
The aim of this study is to investigate potential influence/risk factors important for ICU admission in a university hospital in Germany and develop a risk score. In a second phase the risk score for ICU admission will be validated.
Study Overview
Status
Intervention / Treatment
Detailed Description
It is one of the core duties of anesthesiologists in our hospital to identify patients with high risk for a post-surgery ICU stay upon hospital admission. We do know that there are two types of factors influencing the possibility of an ICU admission: The patient centered risk e.g. severe preconditions and the surgery centered risk depending on the type of surgery with sometimes high possibility for perioperative complications i.e. bleeding, hemodynamic instability, pulmonary complications etc. However, we do not know the effect size of these factors and, equally important, how they are correlated with one another.
The aim of this study is to model the risk of an ICU stay by patient centered and surgery centered influence factors. If a good model is obtained, this can be utilized for allocating ICU capacities in an objective fashion. The study consists of two phases. In the first phase model selection is performed. In the second phase the developed model will be validated on independent data. Data will be gathered by a data collection sheet completed by the responsible anesthesiologists in all elective and emergency surgery during a specific period of time.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Kiel, Germany, 24105
- University Hospital Schleswig-Holstein, Campus Kiel
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All patients ≥ 18 years receiving surgery in the time frame of data collection with ASA classification status I-IV
Exclusion Criteria:
- Patients < 18 years
- ASA classification status > IV
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Group 1
Patients receiving either elective or emergency surgery.
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For each patient the following potential influence (risk) factors are documented: sex, urgency of the operation, BMI, age, ASA classification, preconditions, physical fitness, Hb value. In phase 2 only selected influence factors will be recorded. No intervention will be performed apart from the surgery planned for each patient. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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The necessity of an ICU stay
Time Frame: Immediately after surgery
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This is recorded by the responsible anesthesiologist after the completion of surgery.
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Immediately after surgery
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Collaborators and Investigators
Investigators
- Study Chair: Matthias Grünewald, MD, University Hospital Schleswig-Holstein, Campus Kiel, Germany
Publications and helpful links
General Publications
- Orsini J, Blaak C, Yeh A, Fonseca X, Helm T, Butala A, Morante J. Triage of Patients Consulted for ICU Admission During Times of ICU-Bed Shortage. J Clin Med Res. 2014 Dec;6(6):463-8. doi: 10.14740/jocmr1939w. Epub 2014 Sep 9.
- Lupei MI, Chipman JG, Beilman GJ, Oancea SC, Konia MR. The association between ASA status and other risk stratification models on postoperative intensive care unit outcomes. Anesth Analg. 2014 May;118(5):989-94. doi: 10.1213/ANE.0000000000000187.
- Wanderer JP, Anderson-Dam J, Levine W, Bittner EA. Development and validation of an intraoperative predictive model for unplanned postoperative intensive care. Anesthesiology. 2013 Sep;119(3):516-24. doi: 10.1097/ALN.0b013e31829ce8fd.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ICU Risk Score
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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