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Recruiting NCT07155772

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

No phase Interventional Refractory Cardiac Arrest

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Extracorporeal CardioPulmonary Resuscitation (eCPR).
Who it may be relevant to
Registry conditions: Refractory Cardiac Arrest. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Feasibility Study on a Prehospital Extracorporeal CardioPulmonary Resuscitation in the Pavia's Province. An Interventional Study on Complex Treatment Strategy

Overview

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.

Interventions

  • Procedure 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).

Primary outcome measures

  • number of successful eCPR placed in prehospital settings over patients that meet inclusion criteria [Time frame: up to 12 months]
Secondary outcome measures (3)
  • Cause of cannulation failure [Time frame: up to 12 months]
  • Proportion of cannulation feasibility according to the implant site [Time frame: up to 12 months]
  • Evaluation of eCPR Team Performance [Time frame: up to 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

Italy · 1 center
  • Fondazione IRCCS Policlinico San Matteo — Pavia

Identifiers

NCT: NCT07155772 · eCPR on Site

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗