Prediction of Safe Discharge From ICU

NCT ID: NCT05459350

Last Updated: 2022-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

24010 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-01

Study Completion Date

2022-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Patients who have an increased need for monitoring or therapy during their stay in hospital are typically admitted to an intensive care unit. This is characterized by a large number of diagnostic and therapeutic options. If this additional effort is no longer necessary, then typically in most hospitals patients are transferred to wards with a lower presence of nurses and physicians and reduced provision of extensive monitoring and therapeutic procedures such as organ replacement procedures.

However, deintensification of medical and nursing care requires that previously monitored and partially supported bodily functions are restored to the point where further monitoring is no longer necessary. For this reason, transfer from an intensive care unit to the normal inpatient area is only possible if the patient in question has neither an increased need for monitoring nor an increased need for therapy. If this is not the case, then there is a risk of life-threatening conditions in the normal ward, which can sometimes occur very quickly. However, the need for further monitoring, or for continued intensive medical therapy, cannot be easily assessed. There is no laboratory value or clinical examination method that can be used to estimate beyond doubt whether a patient's condition could worsen if he or she is transferred to the normal ward. For this reason, the decision to transfer is made on the basis of the individual assessment by the attending physician. Although this is based on the synopsis of a wide variety of examinations and laboratory findings, it is therefore subject to large interindividual variations. Thus, the personal experience of the evaluating physician has a considerable influence on the decision for or against a transfer to the normal inpatient area.

In this respect, the decision to deintensify therapy, i.e. to transfer patients from intensive care units to the normal care area, is challenging:

The assessing physician has to make a prediction from the combination of the available findings under time pressure whether a transfer to the normal inpatient area is possible without endangering the patient. In this situation, it would be desirable to have an automated warning system that could describe the success of the transfer with sufficient accuracy in the presence of specific laboratory constellations. In the best case, such an approach would prevent dangerous transfers, but at the same time reduce unnecessary lengths of stay in the ICU. Machine learning methods seem particularly suited to support such a decision.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Risk

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Safe Discharge Positive

Safe Discharge Positive

Safe Discharge Classification

Intervention Type DIAGNOSTIC_TEST

Safe Discharge Classification

Safe Discharge Negative

Safe Discharge Negative

Safe Discharge Classification

Intervention Type DIAGNOSTIC_TEST

Safe Discharge Classification

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Safe Discharge Classification

Safe Discharge Classification

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* All adult patients that were treated in intensive care units at the Kepler University Hospital in Linz, Austria in the period 2010-01-01 to 2019-10-31.

Exclusion Criteria

* None.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kepler University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Thomas Tschoellitsch, MD

Role: PRINCIPAL_INVESTIGATOR

Kepler University Hospital and Johannes Kepler University, Linz, Austria

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kepler University Hospital

Linz, Upper Austria, Austria

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Austria

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SAFEDI

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Geriatrics in the Intensive Care Unit
NCT07001410 NOT_YET_RECRUITING