By: Paul Anderson, Metro Correspondent
Chicago,IL, May 18, 1994 -- According to a recently published article in the Journal of the American Medical Association (JAMA), researchers in Minnesota have found that the use of a"plunger-type device" is more effective in providing Cardio-Pulmonary Resuscitation (CPR) than the standard method. But, a controversy has erupted in the medical community because the Federal Food and Drug Administration (FDA) halted the study because of a lack of "informed consent" on the part of thecardiac arrest patients, who were treated with the device.
The new study was conducted with a device called the "Cardio-Pump", which is used to both compress and "pull bloodback into the heart". In the study, EMT's and Paramedics in St.Paul, MN were specially trained to use the device, and then randomly assigned to use it on cardiac arrest patients. Those that did not receive treatment with the "Cardio-Pump" were given standard CPR treatment in the critical first few minutes following a heart stoppage. The survival outcome of both groups was then compared.
As was expected by both prehospital and medical experts, the survival rate was much better for those patients that received care within ten (10) minutes of their cardiac event. In the study, twenty (20%) percent of those receiving standard CPR and Advanced Life Support (ALS-Paramedic Intervention) procedures, within the first ten minutes, were successful; with an astounding forty (40%) percent of those treated by the "Cardio-Pump" being saved by it's use and standard Paramedic treatment within the same time frames. Overall, the study suggested that twenty-three percent (23%) of cardiac arrest patients were successfully resuscitated with the pump and that seventeen percent (17%) of those treated with current CPR procedures were saved.
Dr. Carin M. Olson, a contributing editor of JAMA, is described as "upset" by an FDA decision to cancel the study at it's mid-point, because the patients in cardiac arrest were not afforded the opportunity to accept or reject the new and virtually unapproved treatment with the "Cardio-Pump". Dr. Olson has suggested that informed-consent regulations be changed to allow for "ground-breaking research" on cardiac arrest patients or those with major head injuries. Doctors and paramedics both agree, that in a crucial "life or death" situation, it is practically impossible to get a "informed patient consent" from either the patient or the family.
Dr. Joe Ornato, Chairman of the American Heart Association (AHA) emergency cardiac care committee, also expressed his approval of more research in this vital area. Dr. Ornato's reasoning is based on the fact that, according to the doctor, "Your talking about a life-or-death situation where our current therapy is nearly hopeless...and the reality is, there is no reasonable way to get informed consent from an unconscious patient".
Clark Staten, Executive Director of the Chicago, IL based Emergency Response & Research Institute, said that the national resuscitation rate of cardiac arrest victims is "at best...dismal". Staten, who studies emergency medical and disaster response issues, said that there are many factors involved in this determination. Staten said that a rapid EMS response to the scene is essential, as well as the early implementation of CPR or other methods of restoring circulation and oxygenation to the brain and heart.
Early defibrillation, administration of "thrombylitic" and other advanced cardiac drugs, and transport to the nearest appropriate hospital are also important factors in successful resuscitations, according to the veteran paramedic. "What is needed, at this point, is the legal and ethical authority to perform the necessary research and development of equipment and procedures that will allow us to take that next step, to find alternative methods to successfully resuscitate the clinically dead", Staten said.
"It is possible that we are very close to several 'break-throughs' in the care of cardiac arrest patients, but both medical personnel and the general population have to realize that certain risks are inevitable in these research efforts", Staten continued. "One thing is certain...anything we can experimentally do to improve the chances of survival of a person who is clinically dead, is warranted...because the alternative is inevitable death", Staten concluded.