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

- Rogue Medic

Why are we still intubating, when there is no evidence of benefit and we refuse to practice this “skill”?

 
Also to be posted on ResearchBlogging.org when they relaunch the site.

The results are in from two studies comparing intubation with laryngeal airways. There continues to be no good reason to intubate cardiac arrest patients. There is no apparent benefit and the focus on this rarely used, and almost never practiced, procedure seems to be more for the feelings of the people providing treatment, than for the patients.
 

Patients with a short duration of cardiac arrest and who receive bystander resuscitation, defibrillation, or both, are considerably more likely to survive and are also less likely to require advanced airway management.22 This problem of confounding by indication is an important limitation of many large observational studies that show an association between advanced airway management and poor outcome in out-of-hospital cardiac arrest.23 This study found that 21.1% (360/1704) of patients who did not receive advanced airway management achieved a good outcome compared with 3.3% (251/7576) of patients who received advanced airway management.[1]

 

In other words, we are the least skilled, are the least experienced, and we have the least amount of practice, but we are attempting to perform a difficult airway skill under the least favorable conditions. Ironically, we claim to be doing what is best for the patient. We are corrupt, incompetent, or both.

We also do not have good evidence that any kind of active ventilation is indicated for cardiac arrest, unless the cardiac arrest is due to respiratory conditions. Passive ventilation, which is the result of high quality chest compressions, appears to produce better outcomes (several studies are listed at the end).

We need to stop considering our harmful interventions to be the standard and withholding harmful treatments to be the intervention. We are using interventions that have well known and serious adverse effects. This attempt to defend the status quo, at the expense of honesty, has not been beneficial to patients.
 

The ETI success rate of 51% observed in this trial is lower than the 90% success rate reported in a meta-analysis.29 The reasons for this discordance are unclear. Prior reports of higher success rates may be susceptible to publication bias.[2]

 

Is that intubation success rate lower than you claim for your organization? Prove it.
 

Another possibility is that some medical directors encourage early rescue SGA use to avoid multiple unsuccessful intubation attempts and to minimize chest compression interruptions.5 Few of the study EMS agencies had protocols limiting the number of allowed intubation attempts, so the ETI success rate was not the result of practice constraints.[2]

 

Is there any reason to interrupt chest compressions, which do improve outcomes that matter, to make it easier to intubate, which does not improve any outcomes that matter? No.
 

While the ETI proficiency of study clinicians might be questioned, the trial included a diverse range of EMS agencies and likely reflects current practice.[2]

 

This is the state of the art of intubation in the real world of American EMS. Making excuses shows that we are corrupt, incompetent, or both.
 


I no longer have the link, but I think that this image came from Rescue Digest a decade ago.
 

These results contrast with prior studies of OHCA airway management. Observational studies have reported higher survival with ETI than SGA, but they were nonrandomized, included a range of SGA types, and did not adjust for the timing of the airway intervention.9,10,31-34 [2]

 

We should start doing what is best for our patients.

We should not continue to defend resuscitation theater – putting on a harmful show to make ourselves feel good.

What would a competent anesthesiologist use in the prehospital setting? Something that offers a benefit to the patient.

There is also an editorial analyzing these two studies.[3]

It is time to start requiring evidence of benefit for everything we do to patients.

Our patients are too important to be subjected to witchcraft, based on opinions and an absence of research.

There is plenty of valid evidence that using only chest compressions improves outcomes.
 

Cardiocerebral resuscitation improves survival of patients with out-of-hospital cardiac arrest.
Kellum MJ, Kennedy KW, Ewy GA.
Am J Med. 2006 Apr;119(4):335-40.
PMID: 16564776 [PubMed – indexed for MEDLINE]

Cardiocerebral resuscitation improves neurologically intact survival of patients with out-of-hospital cardiac arrest.
Kellum MJ, Kennedy KW, Barney R, Keilhauer FA, Bellino M, Zuercher M, Ewy GA.
Ann Emerg Med. 2008 Sep;52(3):244-52. Epub 2008 Mar 28.
PMID: 18374452 [PubMed – indexed for MEDLINE]

Minimally interrupted cardiac resuscitation by emergency medical services for out-of-hospital cardiac arrest.
Bobrow BJ, Clark LL, Ewy GA, Chikani V, Sanders AB, Berg RA, Richman PB, Kern KB.
JAMA. 2008 Mar 12;299(10):1158-65.
PMID: 18334691 [PubMed – indexed for MEDLINE]

Free Full Text at JAMA

Passive oxygen insufflation is superior to bag-valve-mask ventilation for witnessed ventricular fibrillation out-of-hospital cardiac arrest.
Bobrow BJ, Ewy GA, Clark L, Chikani V, Berg RA, Sanders AB, Vadeboncoeur TF, Hilwig RW, Kern KB.
Ann Emerg Med. 2009 Nov;54(5):656-662.e1. Epub 2009 Aug 6.
PMID: 19660833 [PubMed – indexed for MEDLINE]

And more.

 

It is not ethical to insist on giving treatments to patients in the absence of valid evidence of benefit to the patient. We need to begin to improve our ethics.

Also read/listen to these articles/podcasts released after I published this (I do not know the date of the Resus Room podcast) –

The Great Prehospital Airway Debate
August 31, 2018
Emergency Medicine Literature of Note
by Ryan Radecki
Article
 

EM Nerd-The Case of the Needless Imperative
August 31, 2018
EMNerd (EMCrit)
by Rory Spiegel
Article
 

Intubation or supraglottic airway in cardiac arrest; AIRWAYS-2
The Resus Room
Podcast with Simon Laing, Rob Fenwick, and James Yates with guest Professor Jonathan Benger, lead author of AIRWAYS-2.
Podcast, images, and notes
 

Footnotes:

[1] Effect of a Strategy of a Supraglottic Airway Device vs Tracheal Intubation During Out-of-Hospital Cardiac Arrest on Functional Outcome: The AIRWAYS-2 Randomized Clinical Trial
Jonathan R. Benger, MD1; Kim Kirby, MRes1,2; Sarah Black, DClinRes2; et al Stephen J. Brett, MD3; Madeleine Clout, BSc4; Michelle J. Lazaroo, MSc4; Jerry P. Nolan, MBChB5,6; Barnaby C. Reeves, DPhil4; Maria Robinson, MOst2; Lauren J. Scott, MSc4,7; Helena Smartt, PhD4; Adrian South, BSc (Hons)2; Elizabeth A. Stokes, DPhil8; Jodi Taylor, PhD4,5; Matthew Thomas, MBChB9; Sarah Voss, PhD1; Sarah Wordsworth, PhD8; Chris A. Rogers, PhD4
August 28, 2018
JAMA. 2018;320(8):779-791.
doi:10.1001/jama.2018.11597

Abstract from JAMA.

[2] Effect of a Strategy of Initial Laryngeal Tube Insertion vs Endotracheal Intubation on 72-Hour Survival in Adults With Out-of-Hospital Cardiac Arrest: A Randomized Clinical Trial
Henry E. Wang, MD, MS1,2; Robert H. Schmicker, MS3; Mohamud R. Daya, MD, MS4; et al Shannon W. Stephens, EMT-P2; Ahamed H. Idris, MD5; Jestin N. Carlson, MD, MS6,7; M. Riccardo Colella, DO, MPH8; Heather Herren, MPH, RN3; Matthew Hansen, MD, MCR4; Neal J. Richmond, MD9,10; Juan Carlos J. Puyana, BA7; Tom P. Aufderheide, MD, MS8; Randal E. Gray, MEd, NREMT-P2; Pamela C. Gray, NREMT-P2; Mike Verkest, AAS, EMT-P11; Pamela C. Owens5; Ashley M. Brienza, BS7; Kenneth J. Sternig, MS-EHS, BSN, NRP12; Susanne J. May, PhD3; George R. Sopko, MD, MPH13; Myron L. Weisfeldt, MD14; Graham Nichol, MD, MPH15
August 28, 2018
JAMA. 2018;320(8):769-778.
doi:10.1001/jama.2018.7044

Free Full Text from JAMA.

[3] Pragmatic Airway Management in Out-of-Hospital Cardiac Arrest
Lars W. Andersen, MD, MPH, PhD1; Asger Granfeldt, MD, PhD, DMSc2
August 28, 2018
JAMA. 2018;320(8):761-763. doi:10.1001/jama.2018.10824

Abstract from JAMA.

.

Cardiac arrest victim Trudy Jones ‘given placebo’ – rather than experimental epinephrine

 

As part of a study to find out if epinephrine (adrenaline in Commonwealth countries) is safe to use in cardiac arrest, a patient was treated with a placebo, rather than the inadequately tested drug. Some people are upset that the patient did not receive the drug they know nothing about.[1]

The critics are trying to make sure that we never learn.

We need to find out how much harm epinephrine causes, rather than make assumptions based on prejudices.

When used in cardiac arrest, does epinephrine produce a pulse more often?

Yes.

When used in cardiac arrest, does epinephrine produce a good outcome more often?

We don’t know.

In over half a century of use in cardiac arrest, we have not bothered to find out.
 


 

We did try to find out one time, but the media and politicians stopped it.[2]

We would rather harm patients with unreasonable hope, than find out how much harm we are causing to patients.

We would rather continue to be part of a huge, uncontrolled, unapproved, undeclared, undocumented, unethical experiment, than find out what works.

Have we given informed consent to that kind of experimentation?

Ignorance is bliss.

The good news is that the enrollment of patients has finished, so the media and politicians will not be able to prevent us from learning the little that we will be able to learn from this research.[3]

Will the results tell us which patients are harmed by epinephrine?

Probably not – that will require a willingness to admit the limits of what we learn and more research.

What EMS treatments have been demonstrated to improve outcomes from cardiac arrest?

1. High quality chest compressions.
2. Defibrillation, when indicated.

Nothing else.

All other treatments, when tested, have failed to be better than nothing (placebo).

Footnotes:

[1] Cardiac arrest victim Trudy Jones ‘given placebo’
BBC News
23 March 2018
Article

[2] Effect of adrenaline on survival in out-of-hospital cardiac arrest: A randomised double-blind placebo-controlled trial
Jacobs IG, Finn JC, Jelinek GA, Oxer HF, Thompson PL.
Resuscitation. 2011 Sep;82(9):1138-43. Epub 2011 Jul 2.
PMID: 21745533 [PubMed – in process]

Free Full Text PDF Download from reanimacion.net
 

This study was designed as a multicentre trial involving five ambulance services in Australia and New Zealand and was accordingly powered to detect clinically important treatment effects. Despite having obtained approvals for the study from Institutional Ethics Committees, Crown Law and Guardianship Boards, the concerns of being involved in a trial in which the unproven “standard of care” was being withheld prevented four of the five ambulance services from participating.

 

In addition adverse press reports questioning the ethics of conducting this trial, which subsequently led to the involvement of politicians, further heightened these concerns. Despite the clearly demonstrated existence of clinical equipoise for adrenaline in cardiac arrest it remained impossible to change the decision not to participate.

 

[3] Paramedic2 – The Adrenaline Trial
Warwick Medical School
Trial Updates
 

Trial Update – 19 February 2018:
PARAMEDIC2 has finished recruitment and we are therefore no longer issuing ‘No Study’ bracelets. The data collected from the trial is in the process of being analysed and we expect to publish the results in 2018. Once the results have been published, a summary will be provided on the trial website.

 

.

2018 ACLS/PALS/NRP – AHA-ILCOR Guideline questions are being reviewed until 02-21-2017

AHA2015 - 2018
 

In preparation for the 2018 ACLS/PALS/NRP/CPR Guidelines (maybe 2017) the AHA (American Heart Association) and ILCOR (the International Liaison Committee On Resuscitation) are reviewing the questions they ask to examine the evidence, or the lack of evidence, on various interventions addressed by the guidelines for the:
 

First Aid Task Force (Public comment on PICO prioritization has recently closed. PICO categorization public comment period was open from October 10 to 24, 2016)

Advanced Life Support Task Force (Public comment on PICO categorization is NOW OPEN until 12:00 AM CST on February 21st, 2017!)

Basic Life Support Task Force (Public comment on PICO categorization is NOW OPEN until 12:00 AM CST on February 21st, 2017!)

Pediatric Life Support Task Force (Public comment on PICO categorization is NOW OPEN until 12:00 AM CST on February 21st, 2017!)

Education, Implementation and Teams Task Force (Public comment on PICO categorization is NOW OPEN until 12:00 AM CST on February 21st, 2017!)​

Neonatal Life Support Task Force (Public comment on PICO categorization is NOW OPEN until 12:00 AM CST on February 22nd, 2017!)[1]

 

Some questions are obvious and will be continued, such as 428. This is the review of antiarrhythmic drugs for cardiac arrest. Recent research shows no benefit to patients from amiodarone, or lidocaine.[2]

What do the 2015 ACLS Guidelines recommend?
 

Amiodarone may be considered for VF/pVT that is unresponsive to CPR, defibrillation, and a vasopressor therapy (Class IIb, LOE B-R).

Lidocaine may be considered as an alternative to amiodarone for VF/pVT that is unresponsive to CPR, defibrillation, and vasopressor therapy (Class IIb, LOE C-LD).[3]

 

Outside of controlled trials that are large enough to provide useful answers, amiodarone and lidocaine have no place in the treatment of cardiac arrest.
 

Much less obvious is 808, the suggestion that we should ventilate patients in the absence of evidence of benefit from ventilation – at least there is no evidence of benefit for the patient. Hands-only CPR seems to annoy doctors, nurses, paramedics, EMTs, . . . .

Why are we still ventilating adult cardiac arrest patients with cardiac causes of their cardiac arrest in the absence of evidence of safety and in the absence of evidence of benefit?
 

Why is there any question about 788? Results from Paramedic2 should be available next year. Is epinephrine in cardiac arrest better than a placebo?[4]

This is the first time we will have valid evidence to start to decide what to do with a treatment we have been using for over half a century based on the weakest of evidence. Paramedic2 is unlikely to answer many questions, such as which cardiac arrest patients should receive epinephrine and which should not, but it will be a start.
 

Then there is 464Drugs for monomorphic wide complex tachycardia. Considering the recent publication of PROCAMIO and the absence of discussion of tachycardia and bradycardia in the 2015 Guidelines, it is bizarre that this is among the questions recommended for elimination. Since there was no recommendation on treatment of ventricular tachycardia in the 2015 ACLS Guidelines, the recommendation from 2010 continues unchanged.

What did PROCAMIO show? If we give a high enough dose of amiodarone to actually try to treat the arrhythmia, major adverse cardiac events are more common than any benefit.[5]

Are we using amiodarone just to make stable ventricular tachycardia unstable?

Procainamide is safer and more effective.

Cardioversion is safer and more effective.

Adenosine is safer and probably more effective.[6]

Doing nothing is safer and only slightly less effective.

What about blood-letting for stable ventricular tachycardia?

Blood-letting is probably safer and maybe just as effective as amiodarone.[7]

Footnotes:

[1] ILCOR Continuous Evidence Evaluation
AHA (American Heart Association) and ILCOR (the International Liaison Committee On Resuscitation)
ILCOR 2016-2017 PICO categorization and prioritization public comment page

[2] Amiodarone, Lidocaine, or Placebo in Out-of-Hospital Cardiac Arrest.
Kudenchuk PJ, Brown SP, Daya M, Rea T, Nichol G, Morrison LJ, Leroux B, Vaillancourt C, Wittwer L, Callaway CW, Christenson J, Egan D, Ornato JP, Weisfeldt ML, Stiell IG, Idris AH, Aufderheide TP, Dunford JV, Colella MR, Vilke GM, Brienza AM, Desvigne-Nickens P, Gray PC, Gray R, Seals N, Straight R, Dorian P; Resuscitation Outcomes Consortium Investigators..
N Engl J Med. 2016 May 5;374(18):1711-22. doi: 10.1056/NEJMoa1514204.
PMID: 27043165

Free Full Text from NEJM

[3] 2015 Recommendations—Updated
Part 7: Adult Advanced Cardiovascular Life Support
2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care
2015 Recommendations—Updated

[4] Paramedic2 – The Adrenaline Trial
Warwick Medical School
About

[5] Randomized comparison of intravenous procainamide vs. intravenous amiodarone for the acute treatment of tolerated wide QRS tachycardia: the PROCAMIO study.
Ortiz M, Martín A, Arribas F, Coll-Vinent B, Del Arco C, Peinado R, Almendral J; PROCAMIO Study Investigators.
Eur Heart J. 2016 Jun 28. pii: ehw230. [Epub ahead of print]
PMID: 27354046
 

The primary outcome, major adverse cardiac events within 40 minutes of infusion initiation, for procainamide vs. amiodarone, was 9% vs. 41%, p = 0.006. Severe hypotension or symptoms requiring immediate direct current cardioversion (DCCV) occurred in 6.3% vs. 31.0%. Results were similar in patients with structural heart disease (n = 49).

 

[6] Adenosine for wide-complex tachycardia – diagnostic?
Thu, 23 Aug 2012
Rogue Medic
Article

[7] Blood-Letting
Br Med J.
1871 March 18; 1(533): 283–291.
PMCID: PMC2260507
 

Physicians observed of old, and continued to observe for many centuries, the following facts concerning blood-letting.

1. It gave relief to pain. . . . .

2. It diminished swelling. . . . .

3. It diminished local redness or congestion. . . . .

4. For a short time after bleeding, either local or general, abnormal heat was sensibly diminished.

5. After bleeding, spasms ceased, . . . .

6. If the blood could be made to run, patients were roused up suddenly from the apparent death of coma. (This was puzzling to those who regarded spasm and paralysis as opposite states; but it showed the catholic applicability of the remedy.)

7. Natural (wrongly termed ” accidental”) hacmorrhages were observed sometimes to end disease. . . . .

8. . . . venesection would cause hamorrhages to cease.

 

.

Does use of Lights and Sirens save lives?

AmboLights
 

A recent Fire Chief Magazine and the current JEMS have some articles on the use of lights and sirens and the effect on patient outcomes. Doug Wolfberg, one of the EMS lawyers who might be trying to defend your choice on use of lights and sirens, states –
 

Few cows are more sacred in fire service based EMS than the ones that flash, wail and yelp. The use of emergency lights and sirens is an inseparable part of everyday EMS life.[1]

 

and –
 

Yet when we look at the actual evidence, a few things become apparent about RLS use. First, it’s proven to be dangerous. Second, it’s not proven to be beneficial.[2]

 

In another article, several of the top medical directors in the country state –
 

Unlike fire emergencies, which can grow exponentially and spread quickly, only a small subset of medical emergencies is truly time sensitive. Most don’t dramatically worsen in the course of a very few minutes, and they don’t spread from person to person.[3]

 

In rare cases, such as those where we are not able to control bleeding, or breathing, and the hospital is close enough that the patient won’t be dead by the time we get there, does use of lights and sirens save lives? In those rare cases? Sometimes.

Wouldn’t it be better to improve the quality of the people treating these patients, rather than increase the speed of transport?

When is the last time you transported a patient to the emergency department for something that needed to be done immediately to save the life of the patient?

Why not do that before transport?

Was it out of your scope of practice, did you not know what was going on, did you not feel comfortable performing the skill, could you not make up your mind about what to do, . . .?

Can’t place an endotraceal tube successfully? Use an LMA (Laryngeal Mask Airway), King Airway, BVM (Bag Valve Mask or resuscitator bag), stimulate the patient to breathe for himself, . . .

Can’t place an IV successfully? The IV is not a life line, but you can place an IO (IntraOssesous) line, apply direct pressure to bleeding, lay the patient flat (Trendelenberg does not improve things for the patient, although it might make you feel like you are doing something good), consider IM (IntraMuscular) or IN (IntraNasal) administration of medication, . . .

But it is an emergency!
 

We used to drive cardiac arrests to the hospital quickly, because we thought that was better.

We were wrong. If we do not resuscitate people prior to arrival at the hospital, they will probably stay dead. Driving fast just increases the odds that we will be as dead as the patient.

There has never been any good evidence to support driving fast.

We need to develop a better understanding of the treatment we provide. We need to provide better assessments (and continue to assess). We need to provide appropriate treatment on scene prior to transport. We need to rush less.
 

Do you believe in frequent lights and sirens transport?

Here is a dare for you.

Keep track of the times you transport with lights and sirens (these should be sentinel events) and document the actual life saving treatment provided in the emergency department in the first 10 minutes.

Keep track of this for a month, or a year.

Do you have anything?

Was it really something that saved the patient’s life?

If you do come up with something, does it amount to more than 1% of lights and sirens transports?

If we have almost always beenwrong about what is going on, should we be endangering everyone on the road to cover for our ignorance?

Footnotes:

[1] Why running lights and sirens is dangerous
Fire Chief
June 5, 2016
By Douglas M. Wolfberg, Esq.
Article

[2] Pro Bono: EMS Use of Red Lights and Siren Offers High Risk, Little Reward
JEMS
Wed, Feb 1, 2017
Doug Wolfberg
Article

[3] The Case Against EMS Red Lights and Siren Responses
JEMS
Wed, Feb 1, 2017
S. Marshal Isaacs, MD, FACEP, FAEMS , Carla Cash, MD , Osama Antar, MD , Raymond L. Fowler, MD, FACEP, DABEMS
Article

.

Dr. Kudenchuk is Misrepresenting ALPS as ‘Significant’

ResearchBlogging.org
 

The results of ALPS (Amiodarone, Lidocaine, Placebo Study) are clear. There is no statistically significant difference in cardiac arrest outcomes with amiodarone or lidocaine, when compared with placebo.
 

Conclusions Overall, neither amiodarone nor lidocaine resulted in a significantly higher rate of survival or favorable neurologic outcome than the rate with placebo among patients with out-of-hospital cardiac arrest due to initial shock-refractory ventricular fibrillation or pulseless ventricular tachycardia.[1]

 

This study was very well done, but it was not designed to provide valid information about the effects of amiodarone or lidocaine on witnessed arrests or on EMS Witnessed arrests. Maybe the authors were overconfident.

In resuscitation research, we have abundant evidence that overconfidence is much more common than improvements in outcomes. There is no study that has shown an improvement in neurologically intact survival to discharge with any drug. Leaving the hospital with a working brain is the result that matters most to patients. We give drugs because we have too much confidence in the drugs and we are treating our confidence, not because we are doing anything to benefit the patients.
 

I WANT TO BE DECEIVED version of Domenichino, Virgin and Unicorn 1 copy
 

In ALPS there was a subgroup that might have reached statistical significance, but the researchers never determined what would be statistically significant when setting up the study, so these results are merely post hoc data mining (fitting the numbers to allow for a positive spin).

This is the Texas sharpshooter fallacy. The Texas sharpshooter shoots at the side of a barn, then draws targets around the bullet holes so that the the bullet holes are in the bull’s eyes.
 


 

The Texas sharpshooter didn’t shoot at any target, but he went back later and made it look like he hit the center of the target, because he drew the target around the bullet holes. Science requires that we state our hypotheses ahead of time, so that scientists are kept honest. Science requires that we calculate statistical significance ahead of time, especially for secondary outcomes/subgroup analysis, which may mean decreasing the p value to less than 0.03, or to less than 0.01, or even lower to reach statistical significance, so that scientists are kept honest. You are not permitted to bet on the outcome of a horse race that is already in progress for the same reason.

Why do we need to keep scientists honest? Because, as Dr. Peter Kudenchuk unintentionally demonstrates, scientists are just as biased as everyone else. Scientists need to follow the rules of science to minimize the influence of prejudices, such as overconfidence. When scientists do not follow these rules, they are just as easily fooled as everyone else and they may use that self-delusion, and their reputation, to fool others. Dr. Oz makes a fortune telling people what they want to hear about treatments that do not work.

I don’t claim that Dr. Kudenchuk, or even Dr. Oz, is deliberately fooling others, only that they have fooled themselves and are trying to convince others that their prejudices are accurate representations of reality. Here is what Dr. Kudenchuk has been telling people –
 

Researchers have confirmed that certain heart rhythm medications, when given by paramedics to patients with out-of-hospital cardiac arrest who had failed electrical shock treatment, improved likelihood of patients surviving transport to the hospital.[2]

 

The researchers have not confirmed any such thing.

If Dr. Kudenchuk wants to study whether amiodarone or lidocaine or both improve outcomes for witnessed cardiac arrest patients, or for EMS witnessed cardiac arrest patients, he needs to set up a study with all of the criteria for a positive result specified before the start of the study, because this study did not. The study explicitly states this, so Dr. Kudenchuk should be able to just read the study and see that he is wrong. Here is another statement that contradicts the information that was published.
 

Two groups of patients were pre-specified by the study as likely to respond differently to treatment: those with a witnessed cardiac arrest and those with an unwitnessed arrest. When it was originally designed, the study predicted that because patients with witnessed cardiac arrest are recognized and treated sooner, they would more likely be responsive to effective treatments than unwitnessed arrests. When first discovered, patients with an unwitnessed arrest are more likely to have already sustained irreversible organ damage resulting from a longer “down time” and less likely to respond to any treatment. This is precisely what was seen in the study – a statistically significant 5% improvement in survival to hospital discharge in witnessed arrests, and no effect from the drugs in unwitnessed arrests.[3]

 

Why does the published version of the paper contradict Dr. Kudenchuk? One of our biases is to remember things differently from the way things really happened. This is why eyewitness testimony is so often wrong. Here is what the published paper states about the witnessed arrest results.
 

We observed an interaction of treatment with the witnessed status of out-of-hospital cardiac arrest, which is often taken as a surrogate for early recognition of cardiac arrest, a short interval between the patient’s collapse from cardiac arrest and the initiation of treatment, and a greater likelihood of therapeutic responsiveness. Though prespecified, this subgroup analysis was performed in the context of an insignificant difference for the overall analysis, and the P value for heterogeneity in this subgroup analysis was not adjusted for the number of subgroup comparisons. Nonetheless, the suggestion that survival was improved by drug treatment in patients with witnessed out-of-hospital cardiac arrest, without evidence of harm in those with unwitnessed arrest, merits thoughtful consideration.[1]

 

The authors did not adjust the p value, so the authors do not claim that the witnessed cardiac arrest results are statistically significant. They only state that these results merit thoughtful consideration. In other words, if we want to claim this hypothesis is true, we need to set up a study to actually examine this hypothesis.

One earlier study (also by ROC – the Resuscitation Outcomes Consortium) even has similar results.[4],[5] These results are also not statistically significant, but suggest that with larger numbers the results might be significant. So why did the authors set up such a small study? Overconfidence and an apparent lack of familiarity with their own research.
 


 

The Seattle phenomenon (they claim that their resuscitation rate is the highest in America) seems to be due to excellent bystander CPR rates (apparently the highest in America), but that is only good enough for them to be experts on improving bystander CPR rates. The rest is probably due to defibrillation and chest compressions, which are the only prehospital interventions demonstrated to improve neurologically intact survival.

Why does a bystander CPR specialist focus on drugs? Overconfidence and an apparent lack of understanding of the resuscitation research. Dr. Kudenchuk preaches like Timothy Leary about the benefits of drugs and with just as little evidence. We should give appropriate credit for Dr. Kudenchuk’s work on CPR, but we should not mistake that for a thorough understanding of the resuscitation research, even the research with his name attached.
 

A new podcast reviews ALPS. Dominick Walenczak does not notice the mistakes of Dr. Kudenchuk, but he is not one of the researchers, so that is easy to overlook. The rest of the podcast is excellent. Listen to it here.
 

Episode 8: Conquering the ALPS (Study)
CritMedic – Critical Care Paramedicine Podcast
Dominick Walenczak
April 7, 2016
Podcast page
 

Footnotes:

[1] Amiodarone, Lidocaine, or Placebo in Out-of-Hospital Cardiac Arrest.
Kudenchuk PJ, Brown SP, Daya M, Rea T, Nichol G, Morrison LJ, Leroux B, Vaillancourt C, Wittwer L, Callaway CW, Christenson J, Egan D, Ornato JP, Weisfeldt ML, Stiell IG, Idris AH, Aufderheide TP, Dunford JV, Colella MR, Vilke GM, Brienza AM, Desvigne-Nickens P, Gray PC, Gray R, Seals N, Straight R, Dorian P; Resuscitation Outcomes Consortium Investigators.
N Engl J Med. 2016 Apr 4. [Epub ahead of print]
PMID: 27043165

Free Full Text from NEJM

[2] Antiarrhythmic drugs found beneficial when used by EMS treating cardiac arrest
Press release
For Immediate Release:April 4, 2016
NHLBI (National Heart Lung and Blood Institute)
Press release

[3] Dr. Kudenchuk: Study reveals exciting news about cardiac arrest treatment
Lindsay Bosslet
18 hours ago
Public Health Insider
Article

[4] Wide variability in drug use in out-of-hospital cardiac arrest: A report from the resuscitation outcomes consortium.
Glover BM, Brown SP, Morrison L, Davis D, Kudenchuk PJ, Van Ottingham L, Vaillancourt C, Cheskes S, Atkins DL, Dorian P; Resuscitation Outcomes Consortium Investigators.
Resuscitation. 2012 Nov;83(11):1324-30. doi: 10.1016/j.resuscitation.2012.07.008. Epub 2012 Jul 31.
PMID: 22858552 [PubMed – indexed for MEDLINE]

Free Full Text from PubMed Central.

[5] Wide variability in drug use in out-of-hospital cardiac arrest: A report from the resuscitation outcomes consortium – Part I
Mon, 17 Sep 2012
Rogue Medic
Article

 
Kudenchuk, P., Brown, S., Daya, M., Rea, T., Nichol, G., Morrison, L., Leroux, B., Vaillancourt, C., Wittwer, L., Callaway, C., Christenson, J., Egan, D., Ornato, J., Weisfeldt, M., Stiell, I., Idris, A., Aufderheide, T., Dunford, J., Colella, M., Vilke, G., Brienza, A., Desvigne-Nickens, P., Gray, P., Gray, R., Seals, N., Straight, R., & Dorian, P. (2016). Amiodarone, Lidocaine, or Placebo in Out-of-Hospital Cardiac Arrest New England Journal of Medicine DOI: 10.1056/NEJMoa1514204

 

Glover BM, Brown SP, Morrison L, Davis D, Kudenchuk PJ, Van Ottingham L, Vaillancourt C, Cheskes S, Atkins DL, Dorian P, & the Resuscitation Outcomes Consortium Investigators (2012). Wide variability in drug use in out-of-hospital cardiac arrest: A report from the resuscitation outcomes consortium. Resuscitation PMID: 22858552

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Why is progress so slow in resuscitation research?

ResearchBlogging.org
 

Why is progress so slow in resuscitation research? A lot of money and time went in to finding out which type of blood-letting ventilation works best – ignoring the absence of valid evidence that ventilation is better than no ventilation. Why not gamble with our patients?

In response to The Fatal Flaw in Trial of Continuous or Interrupted Chest Compressions during CPR,[1],[2] Kenny commented that –
 

there are many things in your blog that are not correct.[1]

 

I asked for specifics and received the following from Anonymous (maybe Kenny and maybe not) –
 

That the study design ASSUMES we don’t want to know if ventilation is useful or not.[1]

 

Ventilation study implied facepalm
 

Assumes is not many things, but the comments may be from different people and there may be so many things, that Kenny is still documenting all of the examples. Perhaps the following is more specific wording that will satisfy defenders of the study –

    The study design strongly suggests that

        in the attempted resuscitation of adult patients

            with cardiac causes of cardiac arrest

                which is almost all cardiac arrest patients

                    active ventilation does not need evidence,

                        but selecting the favorite flavor of ventilation

                            does need expensive high quality evidence

                                just in case someone ever produces valid evidence

                                    that these patients are not harmed by ventilations

                                        and that these patients receive some benefit from ventilations.
 

That is a lot to assume believe without appropriate evidence.

Based on the available evidence, what are the odds that ventilations are not harmful and are beneficial?
 

Does anyone have any good argument to give ventilations as much as a 50% chance?
 

What about a 40% chance that ventilations will survive a valid study?

How about a 30% chance?

20%?

Is there any justifiable reason to be so optimistic?

If there isn’t any justifiable reason to be optimistic, then we are only making assumptions when we take shortcuts to eliminate the essential research in order to study something that is traditional, rather than based on valid evidence.
 

Do the authors understand that there isn’t valid evidence of any benefit/lack of harm from active ventilations?

Do the authors care that there is not valid evidence of any benefit/lack of harm from active ventilations?

If I have overlooked a third possibility, somebody should let me know. If there is valid evidence, somebody should provide it.

Footnotes:

[1] The Fatal Flaw in Trial of Continuous or Interrupted Chest Compressions during CPR
Wed, 25 Nov 2015 10:15:20
by Rogue Medic
Article

[2] Trial of Continuous or Interrupted Chest Compressions during CPR.
Nichol G, Leroux B, Wang H, Callaway CW, Sopko G, Weisfeldt M, Stiell I, Morrison LJ, Aufderheide TP, Cheskes S, Christenson J, Kudenchuk P, Vaillancourt C, Rea TD, Idris AH, Colella R, Isaacs M, Straight R, Stephens S, Richardson J, Condle J, Schmicker RH, Egan D, May S, Ornato JP; ROC Investigators.
N Engl J Med. 2015 Nov 9. [Epub ahead of print]
PMID: 26550795

Free Full Text from NEJM.

Nichol, G., Leroux, B., Wang, H., Callaway, C., Sopko, G., Weisfeldt, M., Stiell, I., Morrison, L., Aufderheide, T., Cheskes, S., Christenson, J., Kudenchuk, P., Vaillancourt, C., Rea, T., Idris, A., Colella, R., Isaacs, M., Straight, R., Stephens, S., Richardson, J., Condle, J., Schmicker, R., Egan, D., May, S., & Ornato, J. (2015). Trial of Continuous or Interrupted Chest Compressions during CPR New England Journal of Medicine DOI: 10.1056/NEJMoa1509139

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The Fatal Flaw in Trial of Continuous or Interrupted Chest Compressions during CPR

ResearchBlogging.org
 

Trial of Continuous or Interrupted Chest Compressions during CPR — NEJM
 

In conclusion, among patients with out-of-hospital cardiac arrest in whom CPR was performed by EMS providers, a strategy of continuous chest compressions with positive-pressure ventilation did not result in significantly higher rates of survival or favorable neurologic status than the rates with a strategy of chest compressions interrupted for ventilation.[1]

 

This is not a study that has a valid control group to determine if there is any benefit from ventilation. There is no group that does not receive ventilations, so it is like a study of one type of blood-letting vs. another type of blood-letting with the researchers taking for granted that blood-letting does improve outcomes. That is not a problem if blood-letting actually improves outcomes.

Should we take it for granted that blood-letting improves outcomes and that the only hypothesis worth studying is which brand to choose?

Should we assume that ventilations are too sacred to ever be doubted?

Should we assume that there are better arguments for ventilations than for blood-letting? That is not true.
 

If we ignore this fatal flaw, the study is very well done. I really like the study design. It is an excellent example of how to study two different versions of an intervention after that intervention has been demonstrated to improve outcomes, but ventilations have never been demonstrated to improve outcomes in adult patients with cardiac causes of cardiac arrest.

Should we have assumed that blood-letting was too sacred to ever be doubted?
 

We do know that outcomes for seizure patients improve when EMS gives benzodiazepines, because some people cared enough to find out.[2]

Assuming that a treatment is too important to study is like building on a foundation in a swamp.
 


 

We still do not know if there is any benefit from including ventilations, because the study design assumes that we don’t want to know.

There is no good reason to believe that ventilations improve outcomes for adult patients with cardiac causes of cardiac arrest. This study has not done anything to change that.

Our patients deserve better. Why aren’t we finding out what improves outcomes?

Footnotes:

[1] Trial of Continuous or Interrupted Chest Compressions during CPR.
Nichol G, Leroux B, Wang H, Callaway CW, Sopko G, Weisfeldt M, Stiell I, Morrison LJ, Aufderheide TP, Cheskes S, Christenson J, Kudenchuk P, Vaillancourt C, Rea TD, Idris AH, Colella R, Isaacs M, Straight R, Stephens S, Richardson J, Condle J, Schmicker RH, Egan D, May S, Ornato JP; ROC Investigators.
N Engl J Med. 2015 Nov 9. [Epub ahead of print]
PMID: 26550795

Free Full Text from NEJM.

[2] A comparison of lorazepam, diazepam, and placebo for the treatment of out-of-hospital status epilepticus.
Alldredge BK, Gelb AM, Isaacs SM, Corry MD, Allen F, Ulrich S, Gottwald MD, O’Neil N, Neuhaus JM, Segal MR, Lowenstein DH.
N Engl J Med. 2001 Aug 30;345(9):631-7. Erratum in: N Engl J Med 2001 Dec 20;345(25):1860.
PMID: 11547716 [PubMed – indexed for MEDLINE]

Free Full Text from N Engl J Med. with link to PDF Download.

Nichol, G., Leroux, B., Wang, H., Callaway, C., Sopko, G., Weisfeldt, M., Stiell, I., Morrison, L., Aufderheide, T., Cheskes, S., Christenson, J., Kudenchuk, P., Vaillancourt, C., Rea, T., Idris, A., Colella, R., Isaacs, M., Straight, R., Stephens, S., Richardson, J., Condle, J., Schmicker, R., Egan, D., May, S., & Ornato, J. (2015). Trial of Continuous or Interrupted Chest Compressions during CPR New England Journal of Medicine DOI: 10.1056/NEJMoa1509139

Alldredge BK,, Gelb AM,, Isaacs SM,, Corry MD,, Allen F,, Ulrich S,, Gottwald MD,, O’Neil N,, Neuhaus JM,, Segal MR,, & Lowenstein DH. (2001). A Comparison of Lorazepam, Diazepam, and Placebo for the Treatment of Out-of-Hospital Status Epilepticus New England Journal of Medicine, 345 (25), 1860-1860 DOI: 10.1056/NEJM200112203452521

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Our current ambulance system is based on little scientific evidence

 

Our current ambulance system is based on little scientific evidence.

This is one comment by Prachi Sanghavi that has some paramedics very upset.

The video of her short speech at Harvard was posted on EMS1.com[1] and the responses suggested that there is something horribly wrong in the statement, or in any of what followed. There isn’t.
 


 

The problem is with the attitude of those who think that they know everything.

The problem is with the people who oppose finding out if treatments work.

The problem is with people who oppose protecting our patients from harmful treatments.

Prachi Sanghavi discusses the difference between BLS (Basic Life Support) treatment and ALS (Advanced Life Support) treatment. BLS includes all of the prehospital treatment that have evidence of benefit. All of them. ALS includes all of the cool things that paramedics and doctors do before getting to the hospital based on a wish and a prayer, but not on any valid evidence.
 


 

This is a comparison of cardiac arrest outcomes between two similar counties looking at the lack of expected benefit with ALS. There are more variables than just ALS vs. BLS, but we do need to ask Why are these cardiac arrest outcomes so bad with ALS?

Prachi Sanghavi is incorrect about a few things. Paramedics generally use a manual defibrillator, not a semi-automatic defibrillator. Taking longer at a cardiac arrest scene is probably not a problem. Those patients transported without pulses can be expected to end up in the morgue. Moving the patient with ineffective compressions, rather than staying on scene to do compressions well, is not recommended, because it is not supported by evidence. Rushing the patient to the hospital is just rushing the patient to ALS in a building. Yes, there is more ALS available at the hospital, but nothing that has good evidence of improving outcomes. Therapeutic hypothermia, is part of post-resuscitation treatment, not resuscitation treatment. That may change.[2]

Prachi Sanghavi also looked at trauma, stroke, and heart attack. The results were the same. Patients had better outcomes with Basic Life Support.

Our response should be to ask questions.

Are we doing something wrong?

What evidence do we have that ALS treatment improves outcomes?

The problem is that we ignore evidence and make excuses for our willful ignorance.

We are slow to adopt ALS treatments that have good evidence of improving outcomes and much, much slower to get rid of treatments that have only the weakest evidence of benefit – expert opinion. Expert opinion is the basis for all treatments that are later demonstrated to be harmful, so expert opinion isn’t worth bragging about. Real experts understand and learn from the evidence.

Should we trust the people criticizing the message that Maybe more is not better, or should we examine what we have been doing to find out what works?

Why are we opposed to providing the best care we can?

Footnotes:

[1] Researcher: Is BLS better than ALS?
EMS1.com
November 13, 2015
Article

[1] Refractory cardiac arrest treated with mechanical CPR, hypothermia, ECMO and early reperfusion (the CHEER trial).
Stub D, Bernard S, Pellegrino V, Smith K, Walker T, Sheldrake J, Hockings L, Shaw J, Duffy SJ, Burrell A, Cameron P, Smit de V, Kaye DM.
Resuscitation. 2015 Jan;86:88-94. doi: 10.1016/j.resuscitation.2014.09.010. Epub 2014 Oct 2.
PMID: 25281189

Free Full Text from Resuscitation.

This is a tiny study that suggests a grouping of treatments that may work (or that may include a treatment, or two, that may lead to improved outcomes. The results are good, but it is just one tiny study that needs replication and each of the treatments should be studied individually.

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