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NCT04510480 Clinical Trial

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

Cardiac Arrest Clinical Trial

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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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04510480
Other study ID # 1.0
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2020
Est. completion date December 31, 2025

Study information
Verified date February 2022
Source Azienda Usl di Bologna
Contact Federico F Semeraro, MD, FERC
Phone +393336592670
Email f.semeraro@ausl.bologna.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 5000
Est. completion date December 31, 2025
Est. primary completion date July 1, 2021
Accepts healthy volunteers No
Gender All
Age group N/A to 120 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Observational study without specific intervention
Observational study with standard cardiac arrest approach

Locations
Country Name City State
Italy Maggiore Hospital Ospedale Maggiore Carlo Alberto Pizzardi AUSL di Bologna Bologna

Sponsors (1)
Lead Sponsor Collaborator
Azienda Usl di Bologna

Country where clinical trial is conducted

Italy, 

References & Publications (8)

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.resus — View Citation

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.2020.0 — View Citation

Gräsner JT, Lefering R, Koster RW, Masterson S, Böttiger BW, Herlitz J, Wnent J, Tjelmeland IB, Ortiz FR, Maurer H, Baubin M, Mols P, Hadžibegovic I, Ioannides M, Škulec R, Wissenberg M, Salo A, Hubert H, Nikolaou NI, Lóczi G, Svavarsdóttir H, Semeraro F, — View Citation

Gräsner JT, Wnent J, Herlitz J, Perkins GD, Lefering R, Tjelmeland I, Koster RW, Masterson S, Rossell-Ortiz F, Maurer H, Böttiger BW, Moertl M, Mols P, Alihodžic H, Hadžibegovic I, Ioannides M, Truhlár A, Wissenberg M, Salo A, Escutnaire J, Nikolaou N, Na — View Citation

Nolan JP, Monsieurs KG, Bossaert L, Böttiger 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 — View Citation

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 prac — View Citation

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: 1 — View Citation

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;15 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary ROSC (Return of spontaneous circulation) ROSC (Return of spontaneous circulation) of cardiac arrest patients 1st July 2020 to 31st December 2025
Primary Hospital admission status Hospital admission status of cardiac arrest patients 1st July 2020 to 31st December 2025
Primary Hospital discharge status/survival at 30 days Hospital discharge status/survival at 30 days of cardiac arrest patients 30 days
Secondary Survival at 6 months Survival at 6 months of cardiac arrest patients 6 months
Secondary Survival at 1 years Survival at 1 years of cardiac arrest patients 1 year
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