Prediction of Intrahospital Cardiac Arrest Outcomes | NCT05466188

Studies
Prediction of Intrahospital Cardiac Arrest Outcomes

NCT05466188

Sponsor

Kepler University Hospital

Status

Completed

Last Update Posted

May 3, 2023Actual

Enrollment

668Actual

Phase

Not provided

Conditions

Cardiac Arrest

Interventions

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2022Actual

Primary Completion Date

Jul 31, 2022Actual

Completion Date

Jul 31, 2022Actual

First Submitted Date

Jul 12, 2022

First Submission Date that Met QC Criteria

Jul 17, 2022

First Posted Date

Jul 20, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 29, 2023

Last Update Posted Date

May 3, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Intrahospital cardiovascular arrest is one of the most common causes of death in hospitalized patients. In contrast to extramural cases of cardiovascular arrest, hospitalized patients often have severe medical conditions that can affect the outcome of resuscitation. Nevertheless, survival rates from resuscitation are better in hospitals than outside, because there is often a rapid start of resuscitation measures and predefined resuscitation standards. Regular CPR training and the availability of defibrillators in all bedside units can also positively influence outcome. Despite these many efforts, survival rates, especially of patients with good neurological outcome, remained stable at low levels even within hospitals in recent years and did not improve.

Most outcome parameters are nowadays well known. (e.g., initial rhythm, age, early defibrillation, etc.) Nevertheless, we still do not know today how relevant the corresponding factors actually are, especially in relation to each other. One approach to this might be machine learning methods such as "random forest", which might be able to create a predictive model. However, this has not been attempted to date.

The hypothesis of this work is to find out if it is possible to accurately predict the probability of surviving an in-hospital resuscitation using the machine learning method "random forest" and if particularly relevant outcome parameters can be identified.

Design: retrospective data analysis of all data sets recorded in the resuscitation register of Kepler University Hospital.

Measures and Procedure: Review of the registry for missing data as well as false alarms of the CPR team and, if necessary, exclusion of these data sets; evaluation of the data sets using the machine learning method random forest.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

668Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Outcome CPC Positive		Outcome CPC Positive	Diagnostic Test: CPC
Outcome CPC Negative		Outcome CPC Negative	Diagnostic Test: CPC

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CPC	Diagnostic Test	CPC	Outcome CPC Negative Outcome CPC Positive

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AUROC for Classification of Outcome CPC	AUROC for Classification of Outcome CPC	2006-01-01 to 2018-12-31

Secondary Outcomes

Measure	Description	Time Frame
Confusion Matrix	Confusion Matrix Results: true positives, true negatives, false positive, false negatives and values calculated from these results.	2006-01-01 to 2018-12-31
Descriptive Statistics

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All adults patients suffering cardiac arrest and having been resuscitated by the medical emergency team of the Kepler University Hospital, Linz, Austria in the period of 2006-01-01 to 2018-10-31.

Exclusion Criteria:

None.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

120 Years

Standard Ages

AdultOlder Adult

Study Population

As described in the inclusion criteria.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas Tschoellitsch, MD	Kepler University Hospital and Johannes Kepler University, Linz, Austria	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kepler University Hospital		Linz	Upper Austria	4021	Austria

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006323	Heart Arrest

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Descriptive Statistics (age in years, delay in seconds, gender as male/female, agonal breathing/initial rhythm/airway management/iv-access/witnessed cardiac arrest/use of AED/chest compressions as binary features)

This outcome measure will compare the individual feature (e. g. height in cm) in one group vs. the other. Significant difference will be described by p-value.