The take-home message from the long-awaited ResQTrial is that it may be beneficial to “pull up” on the chest during CPR. The recent, multi-center study, funded by the National Institutes of Health, is setting a new bar for cardiac arrest research. It’s the first prospective, randomized, controlled trial of CPR devices that assessed neurological outcomes of cardiac arrest survivors for one year after hospital discharge.
The goal was to compare standard CPR (S-CPR) outcomes to those of patients receiving active compression-decompression CPR (ACD-CPR) in conjunction with an impedance threshold device (ITD). The ACD-CPR device used was the ResQPump—a handheld, manual chest compression device with a suction cup, similar to a fancy toilet plunger. Keith Lurie, MD, one of the study’s co-investigators, invented the device after taking care of a patient who was actually resuscitated with a plunger by his family.
The ResQPump has a force gauge and metronome that guides the rescuer to compress just as in S-CPR, but it also allows them to actively decompress the chest by pulling up with 10–20 lbs. of lift.
The ITD further enhances the negative pressure (vacuum) in the chest, which has been shown in animal and human studies to improve hemodynamics.
The study enrolled 1,653 patients from March 2005–July 2009 in seven U.S. EMS systems. Results were presented at the November American Heart Association Resuscitation Science Symposium, and the full paper was published in Lancet. Survival to hospital discharge with a favorable neurologic outcome in the S-CPR group was 5.8% versus 8.9% in the ACD-CPR plus ITD group—a relative improvement of 53%.
The benefit persisted long-term at one year with 49% more survivors in the ACD-CPR plus ITD group. Nurses doing the follow-up neurologic assessments were blinded, so they weren’t aware of the CPR method the patients received; thus collecting data that was less biased.
The only complication noted to be higher in ACD-CPR plus ITD survivors was an increase in pulmonary edema. These kinds of results are seldom seen in clinical research and are especially rare in resuscitation research. A noteworthy (but not surprising) finding was that few patients in either group survived if CPR wasn’t started within 10 minutes of collapse.
Early in the project, investigators had envisioned three arms to this study: comparing S-CPR versus S-CPR plus ITD versus ACD-CPR plus ITD. However, the S-CPR plus ITD arm wasn’t able to continue because of lower-than-anticipated enrollment and dwindling funding. Previous studies have shown the ITD to be of benefit with S-CPR, and this study demonstrated the benefit when combined with ACD-CPR.
A version of the ResQPump (CardioPump) is available outside the U.S. and sells for $350. The ITD isn’t currently available for sale in the U.S., but the company plans to submit for U.S. Food and Drug Administration (FDA) clearance early next year. So, best estimates are that the device will be available in the U.S. in late 2011. The bottom line is that the ITD has been shown to be beneficial in CPR.
This study adds strong evidence for the use of active compression-decompression CPR in combination with use of an ITD.
—David Page, MS, NREMT-P
FDA focuses on AEDs
The FDA sent a shockwave through manufactures of external defibrillators in November when it notified them of its concerns about how the industry deals with recalls, product failures and manufacturing controls.
“External defibrillators are important, life-saving devices,” wrote Jeffrey Shuren, MD, JD, the FDA’s director of the center for devices and radiological health in a letter to the companies. “However, over the past five years, we have seen persistent safety problems with all types of external defibrillators across all manufacturers of these devices.”
Shuren asked the manufacturers to participate in a two-day workshop held this past December to address the FDA’s concerns and about product innovation.
“It’s not something we saw coming,” says Jonathan Rennert, president of ZOLL Medical Corp., adding that he welcomed the chance to participate in the dialogue.
“I didn’t take [the FDA’s actions] as [meaning] these devices don’t work,” Rennert says. “I think they went out of their way to say they’re life-saving products. Overall, they are very, very reliable.”
The FDA noted there were 68 recalls from Jan. 1, 2005 to July 10, 2010, growing from nine in 2005 to 17 in 2009. Moreover, the FDA stated that there had been 28,000 medical device reports stemming from the use of defibrillators, up from 4,210 in 2005.
“Many of the types of problems we have identified are preventable, correctable and impact patient safety,” Shuren wrote.
Rennert says ZOLL’s data hadn’t uncovered a particular trend in problems.
Derek Smith, senior vice president of Philips Healthcare released a statement about the company’s plans. “Philips is evaluating the information contained in [the FDA] document and fully expects to participate in the industry-wide efforts to advance the safe design, manufacture and use of external defibrillators,” Smith said in the statement. “Philips considers the safety and efficacy of our devices our top priority and we are committed to working with the FDA, clinicians and industry organizations to achieve that goal.”
Getting competitors together to discuss proprietary business issues is rare, indeed, but ZOLL doesn’t take this as an affront. “I think it’s a noble pursuit,” says Rennert. “I take the agency at their word and what they’re trying to drive. That’s the attitude we’re bringing to it.”
—Richard Huff, NREMT-B
Get up-to-date information on the FDA’s External Defibrillator
Improvement Initiative at
Think Before You Click
This month’s legal topic was too hot to hold for print. So Steve Wirth, Esq., EMT-P—founding partner of Page, Wolfberg & Wirth, LLC—wrote an exclusive article with legal advice about posting to Facebook, which appeared on JEMS.com. Here’s an excerpt of the article, but you can read the entire story online:
Can EMS employees be prohibited from bashing their supervisor on Facebook (FB)? That’s one of the issues in a complaint filed by the National Labor Relations Board (NLRB) against American Medical Response (AMR) of Connecticut, where it’s alleged that AMR terminated an employee who posted negative remarks about her boss on her personal Facebook page while off duty.
This case involves the arcane 1935 union protection law, the National Labor Relations Act (NLRA). Section 7 of that act protects the rights of employees to organize and form unions, and the right to engage in “other concerted activities for mutual aid or protection.” That could potentially include activity while both on duty and off duty. What matters most is what the employer does in response to the protected activity (i.e., suspension or termination). The NLRA applies to employees in most private-sector workplaces, including EMS agencies, even where they’re not currently unionized. Public sector employees have similar rights under state labor relations laws.
The ambit of Section 7 is very broad, but it doesn’t give employees the unfettered right to unilaterally lash out against a supervisor or employer in a disparaging way. According to an article in the New York Times on Nov. 9, one of the alleged posts on Facebook by the AMR employee was this: “Love how the company allows a 17 to become a supervisor”—17 is the company lingo for a psychiatric patient—along with some other vulgarities and ridicule of the employee’s supervisor.
Should employees be protected by the law when they disparage a supervisor and call him/her a mental patient in this fashion? We don’t think so. In addition, the complaint against AMR goes deeper than the FB posting, involving other alleged unlawful activity of AMR and misconduct of the employee.
According to the Times article, AMR claims the employee “was also held accountable for negative personal attacks against a co-worker posted publicly on FB” and “believes that the offensive statements made against the co-workers were not concerted activity protected under federal law.” (Keep in mind this is just a complaint, and no hearing has yet been held on the merits of the allegations.)
Pro Bono is written by attorneys Doug Wolfberg and Steve Wirth of Page, Wolfberg & Wirth LLC, a national EMS-industry law firm. Visit the firm’s Web site at www.pwwemslaw.com for more EMS law information.
Read the Legal Consult column in this month’s EMS Insider newsletter for more expert analysis of this hot topic.
The thought of being dispatched to any incident involving a school bus is enough to make an EMS provider’s heart skip a beat. As an EMS provider, these can be some of the most stressful scenes.
As far back as 1966, the University of California, Los Angeles, pioneered research about the need for seatbelts, which led to multiple safety standards that were adopted by the National Transportation Safety Board (NTSB). Mostly, school buses rely on a concept called compartmentalization to protect their passengers, which places the passengers inside a small compartment complete with high seat backs and thick padding to absorb the impact of the occupants—but not seatbelts.
Although school bus safety standards have been evolving since that time, controversy exists within the industry over the standards in place.
But how often do providers face mass casualty incidents involving school buses? The NTSB has acknowledged that statistics concerning school bus accidents are hard to come by, but one group has estimated that 17,000 injuries occur annually.
So as the great debate over seatbelts in school buses rages on, we feel EMS providers have a voice (and a responsibility) to ensure that students get the best care possible in the event they’re injured in one of these crashes. Where do you stand? —Chris Kaiser, NREMT-P
Facebook Status Update
The American Red Cross commissioned a survey of how people would use social media Web sites in an emergency in preparation for the August Emergency Social Data Summit. The idea was to explore how to use the Web as a resource during a disaster.
More than 1,000 people participated in the online survey. The study found that 69% of respondents say, “Emergency response agencies should regularly monitor their Web and social media sites, so they can respond promptly to any requests for help posted there.”
Although that’s unlikely to happen in the near future, social media can be a valuable resource for emergency response agencies, says Greg Friese, director of education for CentreLearn, an online education provider.
People don’t just want to see a “brochure” on the Web anymore. They want to ask questions, and they expect answers. They want something they can interact with, not a page of frequently asked questions. Agencies that hold conversations with visitors to their Facebook or MySpace pages can expect rewards, says Friese.
“If you communicate your values, when it comes time for funding, the public knows more about your value to the community,” he says.
This article originally appeared in January 2011 JEMS as “The Plunger Method: ResQTrial reveals improved cardiac arrest survival rates.”