Development of an ICU Risk Score

Completed

• Conditions: Development of a Risk Score for ICU Admission
• Interventions: Procedure: Patients receiving the surgery planned for them

• Registration Number: NCT02663505
• Lead Sponsor: University Hospital Schleswig-Holstein

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.

Study Timeline

• Study First Submitted: 2016-01-12
• Study First Submitted QC: 2016-01-20
• Study First Posted: 2016-01-26
• Study Start: 2016-02
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-23
• Last Update Posted: 2018-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6918

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Patients receiving the surgery planned for them	Patients receiving either elective or emergency surgery.

Primary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Schleswig-Holstein, Campus Kiel; 🇩🇪 Kiel, Germany