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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInsel Gruppe AG, University Hospital Bern

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • resuscitative endovascular occlusion of the aorta (REBOA)

    Device

    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

  • Advanced Cardiac Life Support (ACLS)

    Other intervention

    Advanced Cardiac Life Support (ACLS) as per American Heart Association (AHA) or European Resuscitation Council (ERC) standards

Treatment groups

98 Participants
are divided into 2 treatment groups
Group A: Advanced Cardiac Life Support (ACLS) aloneActive comparator 1 intervention
Group B: Advanced Cardiac Life Support (ACLS) plus REBOAExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Sustained ROSC

Any return of spontaneous circulation lasting longer then 20 minutes

Time frame
Up to 1 hour after study inclusion

Secondary outcomes

1

Survival to hospital discharge

dead or alive

Time frame
at hospital discharge, up to 90 days after study inclusion
2

Survival to six month

dead or alive

Time frame
6 month after study inclusion
3

neurologic outcome at the time of 30 days

measured by means of modified ranking scale

Time frame
Day 30 after study inclusion
4

neurologic outcome at the time of six month

measured by means of modified ranking scale

Time frame
6 month after study inclusion

Other outcomes

1

non-invasive cerebral oxygenation during resuscitation

Exploratory, measured in %

Time frame
Continuously assessed during ongoing resuscitation, up to 1 hour after study inclusion
2

cause of death

exploratory, written description

Time frame
at six month
3

Troponin T trajectory

exploratory

Time frame
at inclusion, 30 minutes after inclusion and once up to day 3
4

Neuron-Specific Enolase (NSE) trajectory

exploratory

Time frame
at inclusion, 30 minutes after inclusion and once up to day 3

Sponsors and contacts

Click on the lead sponsor to view all of their trials.