Resuscitative Balloon Occlusion of the Aorta in Non-traumatic Out of Hospital Cardiac Arrest
Condition: Out-of-Hospital Cardiac Arrest
MeSH terms: Heart Arrest; Out-of-Hospital Cardiac Arrest
Study type: Interventional

Summary: 
      The primary aim of this study is to investigate the feasibility and complications of
      inserting a REBOA-catheter to patients suffering from non-traumatic out-of-hospital cardiac
      arrest, by anesthesiologist working in the pre-hospital setting. The study will include
      patients in the catchment population of St. Olavs University Hospital, Trondheim area,
      Norway. The REBOA technique (resuscitative balloon occlusion of the aorta) is a well-known
      treatment used on other indications, both in-hospital and pre-hospital. It has also been
      utilized in several animal studies on non-traumatic cardiac arrest and has shown to augment
      myocardial and cerebral perfusion during cardio-pulmonary resuscitation. There are no
      systematic studies on humans with REBOA in non-traumatic cardiac arrest. The study will also
      investigate the time needed to perform a REBOA procedure in cardiac arrest patients receiving
      advanced cardiac life support. This additional treatment might contribute to increase the
      survival rate of cardiac arrest patients.
    

Detailed description: 
      If return of spontaneous circulation (ROSC) is not achieved after advanced cardiac life
      support (ACLS as described in the present guidelines from the Norwegian Resuscitation
      Council) is established, a REBOA catheter is inserted via the femoral artery and the aortic
      balloon inflated, according to a procedure described in a separate document. Ultrasound is
      used to limit risk related to cannulation and placement of the guidewire. The ultrasound
      images will be stored and later processed by the principal investigator. If the physician
      experiences technical problems during the procedure (i.e. severe difficulties in establishing
      vascular access, resistance during insertion of the guidewire, introducer or balloon
      catheter, severe bleeding, prolonged time consumption) the effort will be aborted. If ROSC is
      achieved, the aortic balloon is deflated gently. If the patient re-enters cardiac arrest, the
      normal ACLS-guideline is followed. The balloon is then re-inflated, as described in the
      procedure.
    

Intervention name(s): Resuscitative Balloon Occlusion of the Aorta; REBOA catheter
Intervention type(s): Procedure; Device
Intervention description(s): If return of spontaneous circulation (ROSC) is not achieved after advanced cardiac life support (ACLS) is established, a REBOA catheter is inserted via the femoral artery and the aortic balloon inflated, according to a procedure described in a separate document. Ultrasound is used to limit risk related to cannulation and placement of the guidewire.; Catheter with a Resuscitative Balloon for Occlusion of the Aorta
Other intervention name(s): REBOA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Balloon occlusion; Air ambulances; Aorta; Resuscitation