Development of an ICU Risk Score

NCT ID: NCT02663505

Last Updated: 2018-01-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 6918 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2017-07-31

Brief Summary

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.

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.

Conditions

Development of a Risk Score for ICU Admission

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1

Patients receiving either elective or emergency surgery.

Patients receiving the surgery planned for them

Intervention Type: PROCEDURE

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.

Interventions

Patients receiving the surgery planned for them

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

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

Sponsors

University Hospital Schleswig-Holstein

OTHER

Sponsor Role: lead

Responsible Party

Timo Iden

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthias Grünewald, MD

Role: STUDY_CHAIR

University Hospital Schleswig-Holstein, Campus Kiel, Germany

Locations

University Hospital Schleswig-Holstein, Campus Kiel

Kiel, , Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 25247021 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24781569 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23756454 (View on PubMed)

Other Identifiers

ICU Risk Score

Identifier Type: -

Identifier Source: org_study_id