Feasibility Study on a Prehospital Extracorporeal CardioPulmonary Resuscitation in the Pavia's Province.

Not Applicable

Recruiting

• Conditions: Refractory Cardiac Arrest

• Registration Number: NCT07155772
• Lead Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

Brief Summary

This is a single Center interventional study, assessing the feasibility of a complex treatment strategy where an in-hospital standard care process is applied in an out-of-hospital cardiac arrest.

The objective of this study is to investigate the feasibility of a prehospital eCPR program in the context of the Pavia province in order to reduce the time from cardiac arrest to organ reperfusion with thefarthest aim of improving survival and good neurologic outcomes of patient victims of refractory cardiac arrest.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-26
• Status Verified: 2025-02
• Study First Submitted: 2025-08-07
• Study First Submitted QC: 2025-08-27
• Last Update Submitted: 2025-08-27
• Study First Posted: 2025-09-04
• Last Update Posted: 2025-09-04
• Primary Completion: 2025-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• out-of-hospital cardiac arrest occurred in Pavia province
• the age of the patient is between 18 and 70
• witnessed cardiac arrest
• CPR started within 5 minutes of the patient's collapse or presence of gasping at the arrival of the ACLS team
• eCPR team arrived within 60 minutes of the patient's collapse
• etCO2 ≥ 10 mmHg
• mechanical chest compression is ongoing
• refractory cardiac arrest after at least 15 minutes of ACLS

Exclusion Criteria

• Modified Rankin Scale (mRS) ≥ 3
• Advanced COPD or other advanced pulmonary illness
• End-stage or metastatic neoplasm

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
number of successful eCPR placed in prehospital settings over patients that meet inclusion criteria	up to 12 months	Successful cannulation is described as maintaining an ECMO circulatory flow of 40 ml/kg/min or more for at least 5 minutes.

Secondary Outcome Measures

Name	Time	Method
Cause of cannulation failure	up to 12 months
Proportion of cannulation feasibility according to the implant site	up to 12 months
Evaluation of eCPR Team Performance	up to 12 months	Evaluation of eCPR Team Performance to better design a definitive institutional eCPR program

Trial Locations

Locations (1)

Fondazione IRCCS Policlinico San Matteo; 🇮🇹 Pavia, Pavia, Italy