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Beaumont Hospital in Royal Oak and Troy, along with five emergency medical service (EMS) providers (paramedics, firefighters) in Oakland and Macomb counties and five other community hospitals, is researching whether there's a better way to do cardiopulmonary resuscitation (CPR) for adults who have sudden cardiac arrest in the community setting.
The five EMS providers are in Birmingham, Clawson, Ferndale, Royal Oak, Sterling Heights and Troy. Emergency responders from these EMS providers will identify potential study participants when called to assist adults with sudden cardiac arrest (loss of pulse) unrelated to traumatic injury. The seven community hospitals are Beaumont Royal Oak and Troy; Crittenton; Providence; St. John Macomb; St. John Oakland; St. Joseph's Mercy of Macomb; and St. Joseph's Mercy of Oakland.
The research is to evaluate the effectiveness of two investigational devices used during CPR - the ResQ Pod, a small valve placed on the end of a breathing tube that increases blood flow during CPR; and the ResQ Pump, a hand-held device with a suction cup that attaches to a person's chest, helping to lift the chest back to its resting position after compression.
Initial studies indicate that the devices significantly improve life-sustaining blood flow to the heart and brain during CPR compared to CPR alone; improve survival; and may potentially decrease the risk of brain damage. CPR alone only provides up to 25 percent of blood flow to the heart and brain during cardiac arrest. In earlier studies, the combination of the two new devices during CPR has been shown to improve blood flow by more than three times that amount.
Complications from the suction device used for chest compression are similar to those with standard CPR and include broken ribs and/or breast bone; internal organ damage; vomiting; skin bruising at the point of contact; bruising of the heart or lung; collection of fluid in the lungs; neurologic damage from lack of oxygen; and death. Complications from the valve device could include build-up of fluid in the lungs, but this complication can occur as a result of cardiac arrest and CPR without any devices as well.
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 planned emergency research. Community members who wish to receive CPR but do not want to be part of the study may indicate their desire by informing their family, friends and co-workers who in turn can communicate these wishes to the EMS providers.
After the cardiac arrest patient is hospitalized, an informed consent will be obtained from the patient, family, or legal representative, to allow study investigators to collect follow up information. Further participation in the research is entirely voluntary.
Patients will be divided randomly into three groups. All patients will receive standard advanced life support measures. One group will receive standard CPR alone, another group will receive CPR with the valve device, and a third group will receive CPR with both the valve and chest compression devices.
After the initial CPR treatment and obtaining informed consent, participation in the study will consist of researchers reviewing the patient's medical record to collect information, and phone contacts to assess the patient's progress up to one year after CPR treatment. The researchers at Beaumont will then compare survival rates and brain recovery in patients who had conventional CPR, versus CPR with the valve device and CPR with both of the devices.
For more information on the risks and benefits, waiver of informed consent and other aspects of the study, call principal investigator Robert Swor, D.O., at 248-898-1970, e-mail him at email@example.com or write to him in the Emergency Medicine department at Beaumont Hospital (3601 W. 13 Mile Road, Royal Oak, MI 48073).