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Local emergency patients aren’t done participating in medical studies that allow paramedics to perform experimental treatments on them without their consent.
As I reported Wednesday, the federal government has cancelled two “no-consent” studies performed on trauma patients because early results suggested alternative treatments provided no benefits.
But the city of San Diego’s medical director has confirmed that a similar study began in the city earlier this year, and it isn’t over.
The current study requires paramedics to give different types of treatment to people undergoing cardiac arrest, which is almost always fatal despite the presence of portable defibrillators in many buildings.
Under the study, paramedics in some cases will give 30 seconds of CPR to cardiac-arrest patients before trying to restart their hearts with a defibrillator machine, which checks to see if a shock is necessary.
This is the traditional approach to CPR.
In other cases, patients will get three minutes of CPR to some cardiac-arrest victims before trying to shock the patient. This is thought to perhaps improve the chances of patients by “priming the pump,” said San Diego medical director Dr. James Dunford.
The study will also randomly assign cardiac-arrest patients to receive treatment with a fist-sized device connected to an oxygen mask or breathing tube. It’s thought to help restore blood flow to the heart as paramedics perform CPR, he said.
Patients in the study who don’t receive the actual device will be treated with a “sham” device — a placebo — that doesn’t actually work, Dunford said.
Patients undergoing cardiac arrest could potentially take part in both arms of the study, receiving one of the two types of CPR, performed with either the real or fake device in place.
Ultimately, the study could help doctors figure out which treatments are more effective.
Local residents can opt out of the study by requesting bracelets that say “Do Not Enroll ROC,” a reference to the research project. Anyone who isn’t wearing a bracelet and suffers from cardiac arrest could be part of the study.
The research began in March in the city and earlier in the county, Dunford said. He didn’t know how many people have requested the opt-out bracelets.
The study, which will enroll more than 14,000 patients in the U.S. and Canada, is supposed to end in September.
About 1,000-1,200 people suffer from cardiac arrest in San Diego each year and almost all of them die, Dunford said. Without immediate treatment, the risk of death approaches almost 100 percent in about 10 minutes.
Cardiac arrest refers to disruption in the electrical activity of the heart. A heart attack is a separate phenomenon — it happens when part of the heart muscle dies when an artery is blocked — although it can lead to cardiac arrest.
Researchers are trying to figure out the ideal time to perform CPR before turning to a defibrillator machine. “Shocking someone too soon might be a bad thing, but nobody’s been able to substantiate that,” Dunford said.
It’s very unusual for anyone in medicine to perform research on patients without their permission. But emergency medicine poses a unique dilemma: How can doctors perform research on patients who are often unconscious and can’t say yes or no to a study?
Many medical specialists and bioethicists contend that it’s appropriate to perform no-consent studies on emergency patients because there’s no other feasible way to conduct the research. The bracelets allow people to opt out if they wish.
But George Annas, a bioethicist at Boston University, told the (Ft. Worth) Star-Telegram recently that the system allowing people to opt out is, as the paper paraphrased it, “preposterous and wrong.”
“Who’s going to wear a bracelet? That’s the silliest darn thing I ever saw,” he said. “When you’re in accident, do you want the best treatment? Or do you want them to flip a coin to decide what treatment to use?”
San Diego-area paramedics aren’t flipping coins, although there’s an element of chance to make sure patients randomly receive specific types of treatment. Paramedics in specific areas of the city are told to use one CPR method for a few months and then switch to the other, Dunford said.