NCT04661735

Brief Summary

Subject of the planned project is the retrospective analysis of routine data of digital patient files of the Department for Anaesthesiology and Surgical Intensive Care Medicine, to test whether the predictive values of intensive care scoring systems with regard to perioperative mortality and morbidity can be improved by continuous score calculation and by using machine learning and time series analysis methods.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2006

Completed
14.9 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 10, 2020

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

September 8, 2023

Status Verified

September 1, 2023

Enrollment Period

19.8 years

First QC Date

December 4, 2020

Last Update Submit

September 7, 2023

Conditions

Mortality in Intensive Care UnitsComplications InfectionAlarm Fatigue

Keywords

scoresintensive care unitpatient monitoringalarm management

Outcome Measures

Primary Outcomes (1)

  • Prediction of patient outcome

    Identification of scores with a high on impact mortality, complications and length of stay in the intensive care unit

    2006 - 2023

Secondary Outcomes (2)

  • Predictive model for alarm load

    2020 - 2023

  • Predictive model for actionable alarms

    2020 - 2023

Eligibility Criteria

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

Age from 18 years. The respective intensive care department carries out approximately 5000 intensive care treatments per year on persons of each sex.

You may qualify if:

  • \- Patients with admission between 01.01.2006 and 30.09.2023

You may not qualify if:

  • Patients under 18 years of age.
  • Incomplete patient records.
  • Intensive stay of less than 24 hours.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charite Universtitaetsmedizin

Berlin, 10117, Germany

RECRUITING

MeSH Terms

Conditions

Alert Fatigue, Health Personnel

Condition Hierarchy (Ancestors)

Mental FatigueFatigueSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Study Officials

  • Felix Balzer, Prof

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Felix Balzer, Prof

CONTACT

data-science@charite.de

Akira S Poncette, MD

CONTACT

data-science@charite.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MSc., PhD, Professor

Study Record Dates

First Submitted

December 4, 2020

First Posted

December 10, 2020

Study Start

January 1, 2006

Primary Completion

September 30, 2025

Study Completion

December 31, 2025

Last Updated

September 8, 2023

Record last verified: 2023-09

Locations

DE(1)