A device that raises the head during CPR to improve blood circulation boosted the likelihood that patients in out-of-hospital cardiac arrest (OHCA) reached neurologically intact recovery, a researcher reported.
Patients who received CPR along with the EleGARD “head-up” device were more likely than those in a comparison group to reach “neuro-intact” survival,” according to Paul Pepe, MD, MPH, of the UT Health Science Center at Houston. Specifically:
- CPR started within 13 minutes of the 911 call: odds ratio 2.68 (95% CI 1.17-6.13)
- CPR started within 8 minutes of the 911 call: OR 4.74 (95% CI 1.40-16.01)
ORs were calculated after adjusting for factors such as age, sex, and use of bystander CPR, Pepe explained in a presentation at the Society of Critical Care Medicine virtual Critical Care Congress.
Although the device is “FDA-cleared,” per developer AdvancedCPR Solutions, it hasn’t been tested in a randomized clinical trial (RCT), Pepe told MedPage Today. Still, the findings suggest that it should become a standard part of fire truck equipment “just like the ladder,” stated Pepe, who is also medical director for Dallas County Emergency Medical Services.
He explained that the device aims to improve the low survival rates in patients who undergo CPR after OHCA. Poor blood flow is a key problem, he said, since blood can remain pooled in the head during CPR instead of returning to the heart for recirculation. “We’ve got to get more blood out of the head and into the chest,” he said.
The EleGARD Patient Positioning System slowly raises the head by ballooning over 2 minutes, after an initial 2-minute pump-priming period of CPR, Pepe said.
The current study is based in part on observational data from a January 2022 Resuscitation study in which researchers tracked 227 patients who received CPR with the assistance of the device during treatment by six first responder or emergency medical services (EMS) agencies. All patients were also treated with an automated chest-pumper (Lucas device) and an impedance threshold valve that is designed to boost circulation. “Faster time to deployment of an AHUP [automated head up position] based bundle of care is associated with higher incidence of ROSC [return of spontaneous circulation],” according to those authors.
Pepe’s group matched the 227 patients to a comparison/control group (n=930) in a propensity analysis using data from an AHUP registry. “For rigorous comparisons, conventional CPR…controls were derived from 3 large-scale published OHCA trials involving 5,330 patients from high-performance EMS systems including those that closely monitored, recorded and reported quality of CPR,” the authors stated.
He reported that, among patients treated in <13 minutes, about 11% of patients in the device group reached neuro-intact survival versus about 5% in the comparison group. In those treated in <8 minutes, the percentages were about 22% and about 5%, respectively.
“If you get this on board within 8 to 9 minutes of when someone calls 911, you can get four to five times the rate of neurologically intact survival,” Pepe said. “Even at 18 minutes, it’s better than the conventional treatment.”
AdvancedCPR Solutions reported in 2021 that it received $1.4 million in federal research and development grants for the technology.
But in a 2019 Paramedic Chief Leadership Briefing article, EMS consultant William Toon, EdD, NRP, stressed that the device isn’t ready for general use. He confirmed to MedPage Today that he hasn’t changed his opinion on that at this time, explaining that it’s still not known if combining the EleGARD device with the automated chest-pumper and impedance threshold valve will actually affect patient survival.
“Not one paper has yet to demonstrate that this bundle is superior to an EMS system utilizing high-performance CPR within a well-organized cardiac arrest system,” he said.
He also questioned investing in a device that hasn’t been tested in an RCT (a pilot study has been done in France; one of Pepe’s co-authors is involved in the French study). Together, the EleGARD device, automated chest-pumper, and valve will cost about $7,500, he said, “and this doesn’t include the hidden cost of the total amount of equipment needed on each ambulance, the backstock needed, and the cost of initial and ongoing training needed by the EMS agency personnel to successfully implement this bundle of care.”
That hasn’t stopped some institution’s from adopting the system, such as Baptist Health Medical System in Little Rock, Arkansas.
Pepe said no RCT of the full bundle is planned at this time. In response to Toon’s comments, he noted that studies in cardiac arrest are difficult to control due to the variations in factors like how patients are ventilated or given CPR. Also, top statisticians recommended the propensity-matched approach used in this study, he said.
Pepe pointed out that the current study does in fact compare device results to conventional CPR in high-performing systems. As for cost, Pepe said there’s not much extra expense for training, and the overall cost is quite small in light of the high cost of buying and operating fire engines.
The study was funded by AdvancedCPR Solutions.