REASON 1 Trial: Sonography in Cardiac Arrest

This is a multi-center, prospective, observational trial involving sites across the United States and Canada. Patients will be enrolled through the emergency department either presenting in cardiac arrest, or going into cardiac arrest while in the emergency department. Patients who develop cardiac arrest as inpatients will also be enrolled at centers capable of enrolling inpatients subjects. Advanced Cardiac Life Support (ACLS) protocols and institutional policies for resuscitation will be followed, as is the current standard of care. A patient encounter will conclude upon halting of cardiopulmonary resuscitation. Final disposition of the patient will be evaluated by chart review.

After the initial cardiac arrest and disposition there will be no further direct patient interactions as part of the study except in the setting of repeat cardiac arrest. Patients that have a repeat arrest can undergo a repeated ultrasound exam if they continue to meet inclusion criteria. The repeat episode will be recorded as a continuation of the event and not as a separate enrollment.

Subject data, with Protected Health Information (PHI) removed, will be uploaded into the REDcap web-based database as soon as possible and within 7 days of final disposition. Data will be obtained from initial patient encounter, patient records, and EMS records when available. Additional data may be obtained by chart review to obtain data points not available at initial contact. Individual sites will keep secured records to enable identification of the patient source if data review is required.

Patient information will include 6 types of data, past medical history, events surrounding the cardiac arrest, actions taken by health care professionals, peri-arrest presentation, peri-arrest interventions, and patient outcomes. Health care professional actions can include ACLS medication administration, airway management, chest compressions, defibrillation, pacing, and other resuscitative interventions. Specific data points are listed in the paper version of electronic Case Report Form, CRF, see Appendix A.

Sonography will not hinder or impair resuscitative efforts in any way, including halting CPR or prolonging pauses in cardiopulmonary rescusitation (CPR). Sonographic images will be obtained during designated pauses in chest compressions, as is routine care, during CPR for pulse checks, rhythm checks, and necessary resuscitative procedures.