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Monday, March 3, 2014

"We had a LUCAS save!" - No, you didn't.

I don't get it.

More and more, I'm seeing Facebook posts, newspaper articles, and personal testimony that excitedly describe a "LUCAS save." That is, a successful resuscitation is credited to the use of a mechanical compression device made by Physio-Control. For example:

"Saves man's life!"
Source
"More residents survived thanks to LUCAS!"
Source
"Life-saving CPR technology!"


Source

"Life-saving technology!" "Saves local man!" "Thanks to LUCAS!" Why hasn't this news of Lazarus-like success swept the country? Why are we still doing CPR with our hands?



Doing CPR with our muscles... like a sucker!
 Well, there is one teensy fact that the press releases leave out...

The LUCAS doesn't save lives.
And no, I don't mean this in the clever "guns don't kill people..." sense. 
I mean this in the "proven by science" sense.

Source
This study, published in January, describes the use of the LUCAS in out-of-hospital cardiac arrest. 

 - Methods
The study looked at patients who had a cardiac arrest treated by EMS. They enrolled adults, who had suffered a non-traumatic arrest, and were neither too small, nor too large, to fit in the LUCAS. They randomized patients to either get manual CPR according to 2005 European ACLS guidelines, or to get chest compressions delivered by a LUCAS device.


The teams were well-trained - not only was there initial preparation for the teams with both usual and mechanical techniques, but team members had twice-yearly re-training, as well as random "spot checks" of individual participants using a manikin. Pretty rigorous!

The primary outcome was maintaining survival for 4 hours after ROSC. You can quibble that this isn't as important as, say, neurologically-intact discharge from the hospital, but it's a reasonable goal, and likely easier to achieve.

 - Results
This should have been a slam-dunk for the machine. Mechanical CPR is consistently high-quality, does not fatigue, and frees up EMS workers for other tasks. One more bonus for the machine - the protocol called for defibrillations to be given during the mechanical compressions, something that humans are not usually able to do! In theory, this elimination of the peri-shock pause should have increased survival in the LUCAS-treated patients.


LINC trial protocol

However, after 2500 patients were enrolled, they found squat for differences between manual CPR and the LUCAS. Nothing. No matter what outcome you picked, there was no advantage to using the LUCAS. None.


LINC trial results
 - Interpretation
So that's the end of the LUCAS for routine management of cardiac arrest by EMS, right? We did the research, it was negative, and we took the expensive machines off the rigs. The EMS services that haven't bought them have expressed relief that they didn't lay out the cheddar.

"But the LUCAS..."
But regardless of these completely negative results, people are protesting. They point out that, yeah, maybe this study didn't show a difference. "But the LUCAS..., " they point out...

  • "...delivers better CPR!" 
  • "...can shock during CPR!"
  • "...can do better CPR during transport!"
  • "...doesn't get tired!"
Despite all that, which is likely true, no difference was found in a high-quality trial where the researchers has every opportunity to demonstrate these . This is how clinical research goes - the slaying of appealing theories by means of ugly facts.
The graph is explained HERE, if you're into that sort of thing.

Don't give credit to a piece of plastic!
A recent article over at JEMS describes a successful cardiac arrest resuscitation. The authors write about the myriad contributing factors:
The integrated training between EMS responders and the CPR/AED-equipped police officers; the multilayered, coordinated response and resuscitation effort by police and EMS familiar with the pit-crew approach to resuscitation and use of a mechanical CPR device; and the rapid response and time-to-care by the rescuers—particularly at such a large gathering—were all key factors in this successful resuscitation.
But the authors then go on to emphasize in the last paragraph that the LUCAS "was clearly a part of this successful resuscitation," and that "they’d never seen this type of response in all of their years of managing cardiac arrest cases." 

In other words; "We did okay, but we're pretty sure that this inanimate object should get the lion's share of the glory." 

You know, I think I've seen this before...


"Simpsons already did it!"

The Bottom Line: 
You know what saves lives? 

You

You, and your well-trained team, utilizing the proven techniques that save lives. Believe me, if the LUCAS was able to generate these sorts of results...
 Source
... you would have heard about it by now!

(For another analysis of this trial, plus some interesting comments, read the post Man vs Machine: A CPR Battle to the... over at Ryan Radecki's excellent blog.)

20 comments:

  1. Good CPR and electricity are the Gospel according to the AHA. I think in truth good CPR and a short duration of cardiac arrest before defibrillation are the real answers.

    CCR probably benefits patients the most because it keeps the crews focused on good compressions and defibrillation.

    If the patient has ROSC before the required eight minute delay in advanced airway, I would think that their chances of survival to Category 1 discharge improve.

    From talking to medics who use the Lucas, the biggest benefit is in freeing up a set of hands to do other things. What that translates into is anyone's guess.

    Of course the four hour ROSC goal is meaningless in itself, but you know that.

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  2. True, true, true, and that's anyone's guess; go get the stretcher?

    And I agree, 4 hour survival is meaningless, but it should have been low-hanging fruit if the LUCAS really were that much better.

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    Replies
    1. It should have been low hanging fruit, but I wonder. Let's say that both hands on CPR and Lucas CPR groups had roughly equal 4 hour survival rates. The next step would be to look at CPC scores. What if the Lucas group had significantly better CPC 1 rates? What would be the ramifications?

      Of course if the Lucas group had WORSE CPC 1 rates at discharge or overall worse survival to discharge rates overall, we'd have to rethink that too.

      Delete
    2. If the LUCAS had better CPC 1 survival (which was one of a few secondary outcomes, and thus just hypothesis generating, strictly speaking), that would have been intriguing!

      However, survival to hospital discharge with CPC 1-2 was statistically equivalent, seen in the results table above (8.3% vs 7.8%).

      Delete
  3. I am thrilled that you have 1) called out the adverterorials being run in local news and EMS trade publications, 2) reminded me of the all powerful carbon rod. The other gem from that episode was Homer going to space by default.

    ReplyDelete
    Replies
    1. Speaking of advertorials, I just found this story:

      "Physio-Control President Brian Webster Briefs EMS Medical Directors"

      A sample sentence: "[CEO] Webster sees future Physio-Control products interfacing with patient parameters and field data to enable more “patient-specific care” to be administered."

      Not sure why "patient-specific care" is in quotation marks. Is ROSC "patient-specific?" In any case, evidently not a word of his "briefing" addressed the LINC trial, nor did the copy-writer at JEMS.com mention it. Hey, it was just one of the largest, highest-quality EMS trials of the last year!

      Delete
    2. Couldn't be because Physio is a large advertising in JEMS and a large sponsor for EMS Today, right?

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    3. Physio certainly got the upper hand over Zoll for positioning on the "Diamond Level." Zoll must be chagrined.

      Delete
  4. Very interesting, thanks for highlighting. Are you aware of any research or difference in outcomes with Zoll's baby, the AutoPulse?

    ReplyDelete
    Replies
    1. No, none that I've heard of.

      Delete
    2. Hey Brooks and Daniel, their was a trial done on the AutoPulse that was ceased due to worse outcomes. Seattle conducted some of it and I believe cannot talk about it. The trial was conducted in 2005 and here is a link:

      http://clinicaltrials.gov/show/NCT00120965

      Thanks again for covering this Brooks. Man still as good as machine atm.

      Delete
    3. I hope they publish their results, even being negative. So often there are small "pearls" that can be pulled out of the large RCTs - insights about the population, modern-day "save" rates, etc.

      EMS doesn't have many big RCTs, so have to take evidence where we can!

      Delete
    4. There were two publications resulting from that trial, both linked from the Clinical Trials page.

      JAMA. 2006 Jun 14;295(22):2620-8. (http://www.ncbi.nlm.nih.gov/pubmed/16772625)

      CONCLUSIONS: Use of an automated LDB-CPR device as implemented in this study was associated with worse neurological outcomes and a trend toward worse survival than manual CPR. Device design or implementation strategies require further evaluation.

      Am J Emerg Med. 2010 May;28(4):391-8. doi: 10.1016/j.ajem.2010.02.002. (http://www.ncbi.nlm.nih.gov/pubmed/20466215)

      CONCLUSIONS: The difference in survival that caused early suspension of ASPIRE appears to have been limited to one site after its protocols change. At the time the trial was suspended, the outcomes of patients at the other sites appear to have been trending in favor of the intervention.

      Delete
    5. Just starting to read through that train wreck of papers and letters. What a mess of an aftermath for a trial - a representative table is at the Mill Hill Ave FB page.

      Delete
    6. I have a feeling Site C is Seattle looking at the survival numbers...but you never know.

      Delete
    7. The CIRC trial just came out as an article-in-press examining the AutoPulse and found no difference in outcomes. http://www.resuscitationjournal.com/article/S0300-9572%2814%2900128-2/abstract

      Delete
  5. Thanks for your comments about JEMS coverage of the device. Conflicts of interest are not clearly stated, tho there is the appearance that these exist.
    Also, the comments by the ACEP EMS group members do not reveal conflicts, unfortunately. The discussion also begs the question of the wisdom of "transporting corpses", especially light and sirens/emergency traffic.

    ReplyDelete
  6. Brooks I think another take away is that mechanical does not do pediatric arrests. Your team must be still be trained to a high level to deal with these arrests when the most is on the line. Couple this with a lack of feedback devices on peds codes(ie Zoll's depth detector is not on peds pads) your team needs to practice HP CPR regularly to stay proficient.

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    Replies
    1. A peds code is a rare event, but your point is bigger than that, I understand. A good team will be a good team, with or without certain pieces of equipment.

      A low-quality team, OTOH, probably won't be helped much by one piece of equipment. If they weren't practicing enough before, now they will have extra parts and procedures to deal with, and pull their focus from the true task at hand!

      Delete
  7. This comment has been removed by a blog administrator.

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