Without evidence of benefit, an intervention should not be presumed to be beneficial or safe.

- Rogue Medic

NIH launches trials to evaluate CPR and drugs after sudden cardiac arrest

The NIH (National Institutes of Health) announced two new resuscitation studies. This is not the kind of research to find any private sponsorship, but it is important – well, one study is.

The CCC trial will compare survival-to-hospital-discharge rates for two CPR approaches delivered by paramedics and fire fighters. Persons experiencing cardiac arrest will be randomly assigned to receive continuous chest compressions, or standard CPR by emergency responders. Standard CPR, the approach recommended by the American Heart Association (AHA) for use by emergency responders, includes chest compressions with short pauses for assisted breathing. This approach has been called into question by emerging data suggesting that stopping chest compressions to provide assisted breathing interrupts overall blood flow, thereby lowering survival.[1]

The AHA wants to find some evidence to justify their preferred method of combining chest compressions with ventilations.

There is no evidence that ventilations improve survival from adult cardiac arrest of cardiac origin.

There is evidence that any interruption to compressions decreases survival.

The only known interruption that does not decrease survival is defibrillation.

Not for ventilation.

Not for intubation.

Not for any medication.

Not for application of any CPR machine.

Not for transport.

Not for acupuncture.

Trained emergency personnel will give all participants in the CCC trial three cycles of CPR followed by heart rhythm analysis and, if needed, an electrical shock (defibrillation), applied to the chest. Half will be randomly assigned to receive continuous compressions combined with pause-free rescue breathing and half will receive standard professional CPR.[1]

Why only three cycles?

This suggests that the hypothesis presumes some benefit from ventilations.

Based on what?

Apparently based on tradition and wishful thinking – a deadly combination.

Tradition and wishful thinking have been a deadly combination for thousands of years.

The Amiodarone, Lidocaine, or neither (Placebo) for Out-Of-Hospital Cardiac Arrest Due to Ventricular Fibrillation or Tachycardia study (ALPS) will determine whether amiodarone or lidocaine improves survival-to-hospital-discharge rates for participants with shock-resistant ventricular fibrillation. Participants will receive one or the other drug or a placebo.[1]

We already know that these drugs do not improve survival from V Fib (Ventricular Fibrillation). The only questions are


Image modified from Paramedicine 101 – 2010 AHA Updates.

How many resuscitations does lidocaine prevent?

How many resuscitations does amiodarone prevent?

The CCC trial will enroll up to 23,600 participants at eight major regional locations across the U.S. and Canada.[1]

That number of patients should be enough for clear results.

The ALPS trial will enroll up to 3,000 participants at nine locations across the U.S. and Canada.[1]

That ridiculously small number of patients should allow those who base treatment on tradition and wishful thinking to continue to pretend that their treatments do not make things worse.

Almost 60 fire and EMS organizations will participate in the ALPS trial, and approximately 125 EMS organizations will participate in the CCC trial.[1]

Maybe the number 3,000 is a misprint. That would be only 50 V Fib (Ventricular Fibrillation) cardiac arrests per EMS organization.

Estimated Enrollment:             3000 [2]

How will that produce statistically significant results, while the CPR study requires 8 times as many patients?

Footnotes:

[1] NIH launches trials to evaluate CPR and drugs after sudden cardiac arrest
Embargoed for Release
Thursday, January 26, 2012
11 a.m. EST Contact:
NHLBI Communications Office
(301) 496-4236
NIH
Press Release

[2] Amiodarone, Lidocaine or Neither for Out-Of-Hospital Cardiac Arrest Due to Ventricular Fibrillation or Tachycardia (ALPS)
ClinicalTrials.Gov
Last Updated on September 21, 2011
ClinicalTrials.gov Identifier: NCT01401647
Trial data

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Comments

  1. The CPR study is only 1/2 way there. It compares standard (30:2) CPR with CPR with ventilation during compressions. What would be best is a third group that received compressions with NO ventilations. Then there would be evidence to show whether ventilations help AT ALL, as opposed to just when to do ventilations.

    Does “participants” mean the number of patients, or the number of providers involved? 50 providers per agency is a bit high IMHO, but more reasonable than only using 3000 patients in the study.

    …and I really hate having a common name such as Mike now…

  2. Hey! I got my own study?!?!

    Awesome!

  3. I saw this the other day in the news release and was waiting for your take on it.

    It seems like these studies are a few years behind the curve. Compression only CPR is becoming the norm as far as I know. Have you seen the British Heart Foundation PSA? ( http://www.youtube.com/watch?v=ILxjxfB4zNk ) I have to echo what mpatk said above, why wasn’t compression only CPR included? It would seem to me that we should be trying to confirm the improvements noted by the University of Arizona in their Tuscon study on a larger scale (say like the one described in the article) instead of trying to validate when to breath.

    I’ve been teaching compression only CPR in my training sessions for the past year. I’ve even had an indirect CPR save when one of the people in my CPR class performed compression only CPR on a soccer team mate of his following a sudden collapse before their game started. This was 4 months ago and the victim has had a pacemaker/defibrillator (it was hard to determine which kind exactly due to this being a lay person describing it to me in English as a second language) placed and has made a full recovery. He’s even back out on the soccer field.

    Back on subject, I guess I should be happy that some one is finally looking more closely at a few of the drugs that so many in EMS look at as necessary and benign. If we could only get epi studied in the same way…

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