It is a quiet weeknight in early February at the Chula Vista downtown library when Dr. Dan Davis of UCSD, wearing pale green cotton hospital scrubs, arrives in the auditorium. He's come to make the case for an unorthodox medical trial being conducted by the Resuscitation Outcomes Consortium. He unpacks his laptop computer and sets up his portable projector, then launches into a PowerPoint presentation about the need for the federally funded study.
As he speaks, Donna Kelly, an RN who serves as the trial's coordinator, hands out a ten-page brochure. "Nearly 95% of patients who have an out-of-hospital cardiac arrest die before reaching the hospital," it explains cardiac arrest, unlike the odds on old TV shows such as Emergency, are daunting, Dr. Davis tells his Chula Vista audience. In the words of the brochure: "Someone must recognize the arrest, call 911 to summon the EMS providers, and perform CPR promptly (ideally before the EMS providers arrive). The EMS providers or trained lay rescuers must be able to provide defibrillation or other therapies if needed."
Surprising though it may seem to many, the state of emergency medical knowledge, according to Davis, is still pretty primitive. As the brochure says, "Many existing and proposed therapies have not received rigorous scientific evaluation in the prehospital setting."
Then Davis gets to the reason he has come. There are new, still experimental ways for paramedics to combine CPR and the use of defibrillators -- devices that check for a heartbeat and shock a stopped heart back to life -- that might improve those dismal survival rates. There's also a compact plastic device, a valve that attaches to the air tube or facemask of a patient with cardiac arrest. During CPR, the valve "creates a small vacuum inside the patient's chest, which increases the return flow of blood to the heart," according to a news release from the Resuscitation Outcomes Consortium -- ROC for short. But the doctors don't know for sure that the device improves the odds. Like all of the experimental procedures, it has yet to be fully tested on humans.
The cardiac trial is ROC's second study. The first, which began in San Diego County in mid-February, involves saline solution given trauma patients -- victims of traffic accidents, gunshot, or falls who have suffered massive blood loss, which can quickly lead to brain death.
Conducting a scientific test involves arbitrarily giving one kind of treatment to some patients and another kind to others, decided in a random manner, much like flipping a coin.
For instance, giving one cardiac patient a three-minute period of CPR between shocks and giving another only 30 seconds first. The "standard of care" for the past 15 years has been to go quickly to the defibrillator, but some doctors believe the longer period of CPR prior to defibrillation may be more effective.
Or, in the case of the saline study, giving one trauma patient the normal saline solution (.9 percent salt concentration) and giving another either a high-concentration (7.5 percent, referred to as hypertonic) saline solution or high-concentration saline with dextran, a circulation-enhancing substance.
The studies are "blinded," meaning that the paramedics who administer the treatment do not know the kind of saline solution they are using or whether the plastic airway device works or instead is a dummy model. With enough carefully recorded random attempts, a pattern might emerge that would validate one treatment over the other.
In most medical experiments, the subjects are well enough to decide if they want to participate. Trauma victims and people in cardiac arrest usually aren't; in fact, they are unconscious.
But someone has to be the guinea pig -- at least that's the idea behind the Resuscitation Outcomes Consortium. The Food and Drug Administration has exempted ROC from the usual requirement that experimental subjects furnish their "informed consent" prior to being enrolled in a study in which they may not receive the current standard of care.
In the ROC trials, paramedics in cities across the country have been given special training, equipped with hypertonic saline solution and the plastic airway devices, and provided with a way to randomize treatment on all of their runs.
Thus, every member of the general public, potentially, is fair game.
Initial funding for the Resuscitation Outcomes Consortium is $50 million. The consortium, which comprises 11 centers throughout the United States and Canada, including one in San Diego County, will eventually conduct multiple trials on various cardiac and trauma resuscitation techniques. The University of Washington in Seattle, ROC's Clinical Trial Center, is coordinating the consortium. For its part, UCSD is getting an initial $2.3 million from the project's principal sponsor, the government-run National Institutes of Health.
In exchange for the exemption from the informed-consent requirement, ROC and its participating medical schools and hospitals are required to minimize risk as much as possible.
They are also supposed to spread the word to the public that the experiments are taking place. According to the theory under which the Food and Drug Administration exemption was granted, once the citizenry is apprised of the "risk-benefit ratio" and given the option not to participate by wearing a wristband, the study has met its ethical obligations.
But turning that theory into practice is problematic. Dr. Davis's Chula Vista appearance, part of the university's so-called outreach effort, is a case in point: his audience is composed of just three people. Two are journalists; the third is a friend of one of the writers. One reporter leaves halfway through the talk.
Looking around the virtually empty auditorium to which he has been speaking for almost 90 minutes, Davis says that the study doesn't have enough money for lots of TV spots and other expensive ways of reaching people; despite that hurdle, he insists, the university is trying to get the word out.
But the story is more complicated than that. Though Davis mentions it only fleetingly, the city of San Diego, which was expected to provide many of the subjects for the trials, is not taking part. It quietly opted out last fall after Mayor Jerry Sanders and his staff vetoed a previous agreement to participate.