The First responder Airway & Compression rate Trial (FACT) Study will address basic life
support (BLS) treatments administered by EMS first responders to patients who suffer a
sudden circulatory (pulseless) collapse, referred to as sudden out-of-hospital cardiac
arrest (SCA). The current standard of practice for first responder CPR includes chest
compressions at a rate of 100-120 compressions per minute combined with rescue breathing
using either a bag valve mask (BVM) or a type of oral airway called an i-gel. During
rescue breathing with a BVM, a mask is attached to a breathing bag and placed over the
patient's face. The BVM provides oxygen and clears carbon dioxide out of the lungs by
blowing air through the patient's mouth. Alternatively, the i-gel consists of a short
tube which is inserted in the back of the patient's throat. This tube blows oxygen more
directly into the lungs, bypassing the mouth itself. Each of these breathing methods is
considered standard of care treatment by EMS first responders. Standard of care means
each method is commonly used to treat patients in cardiac arrest and is performed
regularly, depending upon the community in which the cardiac arrest has occurred. The
other component of CPR is chest compressions. The American Heart Association has
recommended a chest compression rate during CPR of between 100-120 compressions per
minute, but has not specified an ideal exact compression rate within this range.
Scientific studies in both animals and clinical studies have shown that these different
standard-of-care approaches to ventilation and the compression rate can produce different
physiologic effects (such as the adequacy of rescue breathing and blood flow) that could
impact clinical outcome. The investigators propose a randomized controlled trial among
persons who suffer SCA to compare these two rescue breathing approaches along with
evaluating a more precise chest compression rate within the range of 100-120 compressions
per minute during CPR. Importantly, each of these treatments fall within established
resuscitation guidelines and are already administered as part of standard care in
clinical practice. Thus this proposed trial will essentially be comparing one
standard-of-care treatment against another standard-of-care treatment.
The study will address two primary aims:
Aim 1: To compare survival to hospital discharge between SCA patients randomized to BVM
versus the i-gel for rescue breathing. The hypothesis is that treatment with i-gel will
result in a higher rate of survival to hospital discharge than BVM.
Aim 2: To compare survival to hospital discharge between SCA patients randomized to chest
compression rates of 100 versus 110 versus 120 per minute. The hypothesis is that
treatment with 100 chest compressions per minute will result in a higher rate of survival
to hospital discharge than compression rates of 110 or 120 per minute.