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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
98
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
Sustained ROSC
Any return of spontaneous circulation lasting longer then 20 minutes
Time frame: Up to 1 hour after study inclusion
Survival to hospital discharge
dead or alive
Time frame: at hospital discharge, up to 90 days after study inclusion
Survival to six month
dead or alive
Time frame: 6 month after study inclusion
neurologic outcome at the time of 30 days
measured by means of modified ranking scale
Time frame: Day 30 after study inclusion
neurologic outcome at the time of six month
measured by means of modified ranking scale
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
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