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

NCT07155772 | Recruiting

• 1 other identifier: eCPR on Site
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Refractory Cardiac Arrest

Keywords

cardiac arrest

Outcome Measures

Primary Outcomes (1)

• number of successful eCPR placed in prehospital settings over patients that meet inclusion criteria

  Successful cannulation is described as maintaining an ECMO circulatory flow of 40 ml/kg/min or more for at least 5 minutes.

  up to 12 months

Secondary Outcomes (3)

• 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

Study Arms (1)

Patients with refractory cardiac arrest who receive extracorporeal cardiopulmonary resuscitation

EXPERIMENTAL

Procedure: Extracorporeal CardioPulmonary Resuscitation (eCPR)

Interventions

Extracorporeal CardioPulmonary Resuscitation (eCPR) PROCEDURE

The intervention of this study consists of moving the current eCPR program out of the hospital to reduce the time from collapse to ECMO flow (low-flow time).

Patients with refractory cardiac arrest who receive extracorporeal cardiopulmonary resuscitation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo

Pavia, Pavia, 27100, Italy

RECRUITING

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Alessandra Palo, MD

CONTACT

+39 0382 50 3711; a.palo@smatteo.pv.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: September 4, 2025
• Study Start: November 26, 2024
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-02

Locations

IT (1)