SSL: Systems Saving Lives - Long-term Survival of Out-of-hospital Cardiac Arrest in the Urban Area of Bologna

Sponsor

Azienda Usl di Bologna (Other)

Overall Status

Recruiting

CT.gov ID

NCT04510480

Collaborator

(none)

5,000

Enrollment

Location

Anticipated Duration (Months)

75.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Evaluation of clinical, logistical, and technical factors (e.g. implementation of pre-arrival instructions, implementation of the DAE RespondER, mechanical chest compressor, REBOA, and E-CPR) that impact on the outcomes of out-of-hospital cardiac arrest patients.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Arrest	Other: Observational study without specific intervention

Study Design

Study Type:

Observational

Anticipated Enrollment :

5000 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Systems Saving Lives - Long-term Survival of Out-of-hospital Cardiac Arrest in the Urban Area of Bologna Following the Implementation of the Pre-arrival Instructions, the DAE RespondER, Mechanical Chest Compressors and Circulatory Support With REBOA and ECMO

Actual Study Start Date :

Jul 1, 2020

Actual Primary Completion Date :

Jul 1, 2021

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
cardiac arrest Out of hospital cardiac arrest patients (Historical cohort) from 1st January 2009 and 30th June 2020. Out of hospital cardiac arrest patients from 1st July 2020 and 31st December 2025.	Other: Observational study without specific intervention Observational study with standard cardiac arrest approach

Arm

Intervention/Treatment

cardiac arrest

Out of hospital cardiac arrest patients (Historical cohort) from 1st January 2009 and 30th June 2020. Out of hospital cardiac arrest patients from 1st July 2020 and 31st December 2025.

Other: Observational study without specific intervention

Observational study with standard cardiac arrest approach

Outcome Measures

Primary Outcome Measures

ROSC (Return of spontaneous circulation) [1st July 2020 to 31st December 2025]
ROSC (Return of spontaneous circulation) of cardiac arrest patients
Hospital admission status [1st July 2020 to 31st December 2025]
Hospital admission status of cardiac arrest patients
Hospital discharge status/survival at 30 days [30 days]
Hospital discharge status/survival at 30 days of cardiac arrest patients

Secondary Outcome Measures

Survival at 6 months [6 months]
Survival at 6 months of cardiac arrest patients
Survival at 1 years [1 year]
Survival at 1 years of cardiac arrest patients

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Out of Hospital cardiac arrest patients (historical cohort) from 1st January 2009 and 30th June 2020
Out of Hospital cardiac arrest patients from 1st July 2020 and 31st December 2025

Exclusion Criteria:

False cardiac arrest
In-hospital cardiac arrest

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maggiore Hospital Ospedale Maggiore Carlo Alberto Pizzardi AUSL di Bologna	Bologna		Italy	40110

Sponsors and Collaborators

Azienda Usl di Bologna

Investigators

Principal Investigator: Federico F Semeraro, MD, FERC, Maggiore Hospital Carlo Alberto Pizzardi AUSL di Bologna

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.

Responsible Party:

Azienda Usl di Bologna

ClinicalTrials.gov Identifier:

NCT04510480

Other Study ID Numbers:

First Posted:

Aug 12, 2020

Last Update Posted:

Feb 16, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Heart Arrest

Out-of-Hospital Cardiac Arrest

Study Results

No Results Posted as of Feb 16, 2022