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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Arrest
• Intervention / Treatment: Other: Observational study without specific intervention

• Study Type: Observational
• Enrollment (Anticipated): 5000

Contacts and Locations

• Study Contact: Name: Federico F Semeraro, MD, FERC; Phone Number: +393336592670; Email: f.semeraro@ausl.bologna.it

Study Locations

• Italy
  • Bologna, Italy, 40110
    • Recruiting
    • Maggiore Hospital Ospedale Maggiore Carlo Alberto Pizzardi AUSL di Bologna
    • Contact: Federico F Semeraro, MD, FERC; Phone Number: +393336592670; Email: f.semeraro@ausl.bologna.it
    • Contact: Giovanni Gordini, MD; Phone Number: +0390516478215; Email: g.gordini@118er.it
    • Sub-Investigator: Lorenzo Gamberini, MD
    • Sub-Investigator: Marco Tartaglione, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 120 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Population served by EMS of Bologna area

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ROSC (Return of spontaneous circulation)	ROSC (Return of spontaneous circulation) of cardiac arrest patients	1st July 2020 to 31st December 2025
Hospital admission status	Hospital admission status of cardiac arrest patients	1st July 2020 to 31st December 2025
Hospital discharge status/survival at 30 days	Hospital discharge status/survival at 30 days of cardiac arrest patients	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival at 6 months	Survival at 6 months of cardiac arrest patients	6 months
Survival at 1 years	Survival at 1 years of cardiac arrest patients	1 year

Collaborators and Investigators

• Sponsor: Azienda Usl di Bologna
• Investigators: Principal Investigator: Federico F Semeraro, MD, FERC, Maggiore Hospital Carlo Alberto Pizzardi AUSL di Bologna

Publications and helpful links

General Publications

• Grasner JT, Wnent J, Herlitz J, Perkins GD, Lefering R, Tjelmeland I, Koster RW, Masterson S, Rossell-Ortiz F, Maurer H, Bottiger BW, Moertl M, Mols P, Alihodzic H, Hadzibegovic I, Ioannides M, Truhlar A, Wissenberg M, Salo A, Escutnaire J, Nikolaou N, Nagy E, Jonsson BS, Wright P, Semeraro F, Clarens C, Beesems S, Cebula G, Correia VH, Cimpoesu D, Raffay V, Trenkler S, Markota A, Stromsoe A, Burkart R, Booth S, Bossaert L. Survival after out-of-hospital cardiac arrest in Europe - Results of the EuReCa TWO study. Resuscitation. 2020 Mar 1;148:218-226. doi: 10.1016/j.resuscitation.2019.12.042. Epub 2020 Feb 3.
• Grasner JT, Lefering R, Koster RW, Masterson S, Bottiger BW, Herlitz J, Wnent J, Tjelmeland IB, Ortiz FR, Maurer H, Baubin M, Mols P, Hadzibegovic I, Ioannides M, Skulec R, Wissenberg M, Salo A, Hubert H, Nikolaou NI, Loczi G, Svavarsdottir H, Semeraro F, Wright PJ, Clarens C, Pijls R, Cebula G, Correia VG, Cimpoesu D, Raffay V, Trenkler S, Markota A, Stromsoe A, Burkart R, Perkins GD, Bossaert LL; EuReCa ONE Collaborators. EuReCa ONE-27 Nations, ONE Europe, ONE Registry: A prospective one month analysis of out-of-hospital cardiac arrest outcomes in 27 countries in Europe. Resuscitation. 2016 Aug;105:188-95. doi: 10.1016/j.resuscitation.2016.06.004. Epub 2016 Jun 16. Erratum In: Resuscitation. 2016 Dec;109 :145-146.
• Del Giudice D, Semeraro F, Ristagno G, Picoco C, Cordenons F, Dell'Arciprete O, Mora F, Scapigliati A, Gordini G. DAE RespondER: The Emilia Romagna app for a regional "community saving lives" system. Resuscitation. 2019 Dec;145:34-36. doi: 10.1016/j.resuscitation.2019.10.002. Epub 2019 Oct 15. No abstract available.
• Oving I, Masterson S, Tjelmeland IBM, Jonsson M, Semeraro F, Ringh M, Truhlar A, Cimpoesu D, Folke F, Beesems SG, Koster RW, Tan HL, Blom MT; ESCAPE-NET Investigators. First-response treatment after out-of-hospital cardiac arrest: a survey of current practices across 29 countries in Europe. Scand J Trauma Resusc Emerg Med. 2019 Dec 16;27(1):112. doi: 10.1186/s13049-019-0689-0.
• Di Marco S, Tucci R, Tonelli G, Frione G, Semeraro F, Ristagno G, Scapigliati A. Preparedness for telephone dispatch-assisted cardiopulmonary resuscitation in Italy. A National survey. Resuscitation. 2020 Apr;149:87-88. doi: 10.1016/j.resuscitation.2020.02.007. Epub 2020 Feb 18. No abstract available.
• Semeraro F, Gamberini L, Tartaglione M, Mora F, Dell'Arciprete O, Cordenons F, Del Giudice D, Picoco C, Gordini G. An integrated response to the impact of coronavirus outbreak on the Emergency Medical Services of Emilia Romagna. Resuscitation. 2020 Jun;151:1-2. doi: 10.1016/j.resuscitation.2020.03.005. Epub 2020 Mar 20. No abstract available.
• Scquizzato T, Burkart R, Greif R, Monsieurs KG, Ristagno G, Scapigliati A, Semeraro F. Mobile phone systems to alert citizens as first responders and to locate automated external defibrillators: A European survey. Resuscitation. 2020 Jun;151:39-42. doi: 10.1016/j.resuscitation.2020.03.009. Epub 2020 Apr 3. No abstract available.
• Nolan JP, Monsieurs KG, Bossaert L, Bottiger BW, Greif R, Lott C, Madar J, Olasveengen TM, Roehr CC, Semeraro F, Soar J, Van de Voorde P, Zideman DA, Perkins GD; European Resuscitation Council COVID-Guideline Writing Groups. European Resuscitation Council COVID-19 guidelines executive summary. Resuscitation. 2020 Aug;153:45-55. doi: 10.1016/j.resuscitation.2020.06.001. Epub 2020 Jun 7.

Helpful Links

• EMS regional website
• DAE RespondER website

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2020
• Primary Completion (ACTUAL): July 1, 2021
• Study Completion (ANTICIPATED): December 31, 2025

Study Registration Dates

• First Submitted: July 9, 2020
• First Submitted That Met QC Criteria: August 11, 2020
• First Posted (ACTUAL): August 12, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 16, 2022
• Last Update Submitted That Met QC Criteria: February 15, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: 1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No