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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Advanced Cardiac Life Support (ACLS) alone | Active Comparator | Advanced Cardiac Life Support (ACLS) as per the hospitals standard protocol, including advanced interventions such as extended cardio-pulmonary resuscitation (eCPR). |
|
| Advanced Cardiac Life Support (ACLS) plus REBOA | Experimental | Advanced Cardiac Life Support (ACLS) as per the hospitals standard protocol, including advanced interventions such as eCPR plus resuscitative balloon occlusion of the descending thoracic aorta (REBOA). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained ROSC | Any return of spontaneous circulation lasting longer then 20 minutes | Up to 1 hour after study inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Survival to hospital discharge | dead or alive | at hospital discharge, up to 90 days after study inclusion |
| Survival to six month | dead or alive |
| Measure | Description | Time Frame |
|---|---|---|
| non-invasive cerebral oxygenation during resuscitation | Exploratory, measured in % | Continuously assessed during ongoing resuscitation, up to 1 hour after study inclusion |
| cause of death | exploratory, written description |
Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wolf E Hautz, MD, MME | Contact | +41 31 632 57 01 | wolf.hautz@insel.ch | |
| Cornelia Lammbrigger, RN | Contact | +41 31 632 57 01 | ukn.studynurse@insel.ch |
| Name | Affiliation | Role |
|---|---|---|
| Wolf E Hautz, MD, MME | Inselspital University Hospital Bern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inselspital University Hospital Bern | Recruiting | Bern | 3010 | Switzerland |
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| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D022561 | Advanced Cardiac Life Support |
| ID | Term |
|---|---|
| D016887 | Cardiopulmonary Resuscitation |
| D012151 | Resuscitation |
| D004638 | Emergency Treatment |
| D013812 | Therapeutics |
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| Advanced Cardiac Life Support (ACLS) | Other | Advanced Cardiac Life Support (ACLS) as per American Heart Association (AHA) or European Resuscitation Council (ERC) standards |
|
| 6 month after study inclusion |
| neurologic outcome at the time of 30 days | measured by means of modified ranking scale | Day 30 after study inclusion |
| neurologic outcome at the time of six month | measured by means of modified ranking scale | 6 month after study inclusion |
| 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 |
| at six month |
| Troponin T trajectory | exploratory | at inclusion, 30 minutes after inclusion and once up to day 3 |
| Neuron-Specific Enolase (NSE) trajectory | exploratory | at inclusion, 30 minutes after inclusion and once up to day 3 |
| D008020 |
| Life Support Care |
| D005791 | Patient Care |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |