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Recruiting NCT07434726

In-hospital Cardiopulmonary Resuscitation With Balloon Occlusion of the Descending Aorta

No phase Interventional 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: resuscitative endovascular occlusion of the aorta (REBOA), Advanced Cardiac Life Support (ACLS).
Who it may be relevant to
Registry conditions: Cardiac Arrest. Basic parameters: from 18 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
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

CPReboa: In-hospital Cardiopulmonary Resuscitation With Balloon Occlusion of the Descending Aorta

Overview

This study will test if a sustained Return of Spontaneous Circulation (ROSC) in patients with cardiac arrest is more frequent when patients receive advanced cardiac life support (ACLS) alone or when they receive ACLS plus a balloon occlusion of the thoracic aorta.

Detailed description

Patients with in-hospital cardiac arrest (IHCA) outside the operating room, the coronary angiography suite and the intensive care unit (ICU) will be attended to by the hospitals resuscitation team and provided with advanced cardiac life support (ACLS) as per usual practice.

A research team will be deployed simultaneously and, when patients meet inclusion criteria, will randomize patients to ACLS alone or to ACLS plus balloon occlusion of the descending thoracic aorta by means of a resuscitative endovascular occlusion of the aorta (REBOA) catheter.

Interventions

  • Device resuscitative endovascular occlusion of the aorta (REBOA)
    Insertion of a balloon catheter through the common femoral artery, retrograde advancement of the catheter into the descending thoracic aorta, ballon occlusion of the aorta
  • Other Advanced Cardiac Life Support (ACLS)
    Advanced Cardiac Life Support (ACLS) as per American Heart Association (AHA) or European Resuscitation Council (ERC) standards

Primary outcome measures

  • Sustained ROSC [Time frame: Up to 1 hour after study inclusion]
Secondary outcome measures (6)
  • Survival to hospital discharge [Time frame: at hospital discharge, up to 90 days after study inclusion]
  • Survival to six month [Time frame: 6 month after study inclusion]
  • neurologic outcome at the time of 30 days [Time frame: Day 30 after study inclusion]
  • neurologic outcome at the time of six month [Time frame: 6 month after study inclusion]
  • ICU-free days before hospital discharge [Time frame: at hospital discharge, up to 90 days after study inclusion]
  • ICU-free days at 30 days [Time frame: 30 days after study inclusion]

Eligibility criteria

Inclusion criteria

  • patients suffering from in hospital cardiac arrest (IHCA), including patients with out of hospital cardiac arrest (OHCA) and return of spontaneous circulation (ROSC), transported to the emergency department, where they suffer a second arrest (IHCA)
  • successful placement of a femoral artery introducer sheath
  • any electrical cardiac activity seen in the initial rhythm analysis
  • ongoing effort of resuscitation as determined by study-independent resuscitation lead

Exclusion criteria

  • IHCA in the operating room, on intensive care unit or in the cardiac catheter laboratory
  • hospital visitors suffering from cardiac arrest
  • asystole seen in the initial rhythm analysis
  • (presumed) age under 18 years
  • known "do not resuscitate"-order
  • known or obvious pregnancy
  • traumatic cardiac arrest
  • known aortic pathologies that render cannulation impossible
  • known allergies to radiographic contrast agents

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

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Switzerland · 1 center
  • Inselspital University Hospital Bern — Bern

Identifiers

NCT: NCT07434726 · CPReboa

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗