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

NCT ID: NCT07155772

Last Updated: 2025-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-26

Study Completion Date

2025-10-31

Brief Summary

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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

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Conditions

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Refractory Cardiac Arrest

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Patients with refractory cardiac arrest who receive extracorporeal cardiopulmonary resuscitation

Group Type EXPERIMENTAL

Extracorporeal CardioPulmonary Resuscitation (eCPR)

Intervention Type 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).

Interventions

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Extracorporeal CardioPulmonary Resuscitation (eCPR)

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).

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role lead

Responsible Party

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Alessandra Palo

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fondazione IRCCS Policlinico San Matteo

Pavia, Pavia, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Alessandra Palo, MD

Role: CONTACT

+39 0382 50 3711

Facility Contacts

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Alessandra Palo, MD

Role: primary

+39 0382 50 3711

Other Identifiers

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eCPR on Site

Identifier Type: -

Identifier Source: org_study_id

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