Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2026-03-08 @ 11:00 PM
Study NCT ID:
NCT05471193
Status:
COMPLETED
Last Update Posted:
2022-08-17
First Post:
2022-07-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prediction of Cardiac Instability in Intensive Care
Sponsor:
Kepler University Hospital
Organization:
Study Overview
Official Title:
Prediction of Cardiac Instability in Intensive Care
Status:
COMPLETED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRECAIN
Brief Summary:
A large number of different organ functions are recorded in real time for patients who are monitored in an intensive care unit. On the one hand, the measured values collected in this way are used for continuous monitoring of vital parameters, but they are also evaluated several times a day in order to be able to make decisions regarding further diagnostics and therapy. In the first case, threshold values can be defined, and if these are exceeded or fallen short of, the treatment team is automatically alerted. If these limits are set too liberally, then the alert will only indicate an acute risk to the patient, where extensive pathophysiological changes have already occurred. If the limits are chosen too restrictively, then there are frequent false alarms, since the limits are exceeded in most cases due to natural fluctuation, without this having any pathological value. The consequence is a so-called "alarm fatigue", which in the worst case leads to ignoring correct alarms and thus endangers the patients. By design, all of these readings only show the status quo of a patient. It is the task of the treatment team to predict from the course of these readings whether a threatening situation is developing for the patient.
For daily clinical practice, it would be better if dangerous changes in vital signs could be predicted. In this case, it would be possible to intervene therapeutically not only when a dangerous situation has arisen, but to try to avert this situation through adequate measures by changing the therapy strategy. In such a case, the treatment team would no longer be confronted with emergency alarms, but could counteract an impending deterioration with a long lead time.
The first approaches for detecting a drop in blood pressure, for example, which are based on simple models, are already in clinical use.
For daily clinical practice, it would be better if dangerous changes in vital signs could be predicted. In this case, it would be possible to intervene therapeutically not only when a dangerous situation has arisen, but to try to avert this situation through adequate measures by changing the therapy strategy. In such a case, the treatment team would no longer be confronted with emergency alarms, but could counteract an impending deterioration with a long lead time.
The first approaches for detecting a drop in blood pressure, for example, which are based on simple models, are already in clinical use.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: