Development of an ICU Risk Score

January 23, 2018 updated by: Timo Iden, University Hospital Schleswig-Holstein

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

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

Observational

Enrollment (Actual)

6918

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Kiel, Germany, 24105
        • University Hospital Schleswig-Holstein, Campus Kiel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients meeting inclusion criteria and receiving elective or emergency surgery

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Patients receiving either elective or emergency surgery.

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
The necessity of an ICU stay
Time Frame: Immediately after surgery
This is recorded by the responsible anesthesiologist after the completion of surgery.
Immediately after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Matthias Grünewald, MD, University Hospital Schleswig-Holstein, Campus Kiel, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

January 12, 2016

First Submitted That Met QC Criteria

January 20, 2016

First Posted (Estimate)

January 26, 2016

Study Record Updates

Last Update Posted (Actual)

January 25, 2018

Last Update Submitted That Met QC Criteria

January 23, 2018

Last Verified

January 1, 2018

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)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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