Media Contact:
Lauren Stokes, Media Relations
Saint Joseph Mercy Health System
734-712-4033
stokesle@trinity-health.org
Cardiopulmonary resuscitation research study may change the way CPR is delivered
08/06/2007
ANN ARBOR, Mich. - St. Joseph Mercy Hospital, the University of Michigan
Hospital, Huron Valley Ambulance, Livingston County Ambulance and all emergency
medical service (EMS) providers in the Washtenaw/Livingston EMS system, are
conducting a research study to evaluate the effectiveness of two investigational
biomedical devices that may change the way cardiopulmonary resuscitation (CPR)
is delivered. The two investigational devices are called ResQPOD and ResQPump
and preliminary studies indicate that these devices improve blood flow during
CPR, which may improve survival after cardiac arrest.
The lead research institution on this study is St. Joseph Mercy Hospital. Researchers
will compare survival rates and neurological outcome in patients with cardiac
arrest receiving conventional CPR, to patients with cardiac arrest receiving
conventional CPR along with the use of the ResQPOD and ResQPump.
“Initial studies indicate the devices improve blood flow during CPR and
may improve survival,” says Dr. Robert Domeier, emergency medicine physician
at St. Joseph Mercy Hospital, medical director for the Washtenaw/Livingston
Medical Control Authority and lead researcher in the study. “This is an
important study to participate in because it may provide important information
necessary for FDA approval of a better method of caring for members of our community
experiencing cardiac arrest.”
Because it is not possible to obtain informed consent from people who are in
cardiac arrest, this study meets the U.S. Food and Drug Administration's
requirements for an exception from informed consent for emergency research.
This type of research has been allowed since 1996 under a ruling called “exception
from informed consent” or EFIC. It allows research without the standard
requirement that before patients can be enrolled in a randomized study, they
or their representatives must give “informed consent.” This type
of study offers an important opportunity to expand treatment options for patients
in cardiac arrest.
In order to protect patients' rights and safety, this study will receive
special scrutiny and oversight from the participating institutions' research
review boards. In addition, members of the public will be able to get information
and give input on the study before it begins. Three community consultation meetings
will be held: Aug. 20 at the Ann Arbor District Library - Downtown Branch
from 6-8 p.m.; Aug. 22 in Saint Joseph Mercy Livingston Hospital's community
rooms from 7-9 p.m. in Howell; and Aug. 23 at St. Joseph Mercy Hospital's
education center auditorium in Ypsilanti from 7-9 p.m. The public is welcome
and encouraged to attend any of these informational meetings.
Local Hospitals expected to participate in the study include St. Joseph Mercy
Hospital, the University of Michigan Health System, Saint Joseph Mercy Saline
Hospital, Saint Joseph Mercy Livingston Hospital and Chelsea Community Hospital.
EMS providers participating in the study include: Huron Valley Ambulance, Livingston
County Ambulance, Stockbridge Ambulance, and fire departments in Ann Arbor,
Ann Arbor Township, Augusta Township, Brighton, Chelsea, Dexter, Fenton, Fenton
Township, Fowlerville, Green Oak Township, Hamburg Township, the Hartland/Deerfield/Tyrone
Fire Authority, Howell, Lyon Township, Manchester, Milan, Northfield Township,
Pittsfield Township, Putnam Township, Salem Township, Saline, Scio Township,
South Lyon, Superior Township, Ypsilanti, Ypsilanti Township and Unadilla.
For more information about this ResQ study, please call the study coordinator,
Jennifer Fowler, at 734-712-1316.
ResQ Study Frequently Asked Questions
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