Cardiac Arrest
Conditions
Keywords
Cardiac Arrest, resuscitative endovascular occlusion of the aorta REBOA, cardio pulmonary resuscitation CPR, advanced cardiac life support ACLS
Brief summary
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
DEVICEresuscitative 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
Advanced Cardiac Life Support (ACLS) as per American Heart Association (AHA) or European Resuscitation Council (ERC) standards
Sponsors
Insel Gruppe AG, University Hospital Bern
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sustained ROSC | Up to 1 hour after study inclusion | Any return of spontaneous circulation lasting longer then 20 minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival to hospital discharge | at hospital discharge, up to 90 days after study inclusion | dead or alive |
| Survival to six month | 6 month after study inclusion | dead or alive |
| neurologic outcome at the time of 30 days | Day 30 after study inclusion | measured by means of modified ranking scale |
| neurologic outcome at the time of six month | 6 month after study inclusion | measured by means of modified ranking scale |
| ICU-free days before hospital discharge | at hospital discharge, up to 90 days after study inclusion | — |
| ICU-free days at 30 days | 30 days after study inclusion | — |
Countries
Switzerland
Contacts
CONTACTTanja Birrenbach, MD, MME
CONTACTCornelia Lammbrigger, RN
PRINCIPAL_INVESTIGATORTanja Birrenbach, MD, MME
Inselspital University Hospital Bern
Outcome results
None listed