Resuscitation Theater

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

- Rogue Medic

Interim Guidance for Basic and Advanced Life Support in Adults, Children, and Neonates With Suspected or Confirmed COVID-19 – April 9, 2020

Wed, 15 Apr 2020 18:30:50 -0400 by Rogue Medic

All of the revised guidelines are at the end.

Treatment of cardiac arrest in the time of a pandemic requires changes to the ACLS (Advanced Cardiac Life Support), PALS (Pediatric Advanced Life Support), and NRP (Neonatal Resuscitation Program) guidelines. These were written specifically for COVID-19, but would apply just as well to any other pandemic with the possibility of aerosolized respiratory transmission.

Who is making these recommendation?

From the Emergency Cardiovascular Care Committee and Get With the Guidelines®-Resuscitation Adult and Pediatric Task Forces of the American Heart Association in Collaboration with the American Academy of Pediatrics, American Association for Respiratory Care, American College of Emergency Physicians, The Society of Critical Care Anesthesiologists, and American Society of Anesthesiologists: Supporting Organizations: American Association of Critical Care Nurses and National EMS Physicians^[1]

Why are these recommendations being made?

Hypoxemic respiratory failure secondary to acute respiratory distress syndrome (ARDS), myocardial injury, ventricular arrhythmias, and shock are common among critically ill patients and predispose them to cardiac arrest,^5-8 as do some of the proposed treatments, such as hydroxychloroquine and azithromycin, which can prolong the QT.⁹ With infections currently growing exponentially in the United States and internationally, the percentage of cardiac arrests with COVID-19 is likely to increase.

Healthcare workers are already the highest risk profession for contracting the disease.¹⁰ This risk is compounded by worldwide shortages of personal protective equipment (PPE). Resuscitations carry added risk to healthcare workers for many reasons. First, the administration of CPR involves performing numerous aerosol-generating procedures, including chest compressions, positive pressure ventilation, and establishment of an advanced airway. During those procedures, viral particles can remain suspended in the air with a half-life of approximately 1 hour and be inhaled by those nearby.¹¹ Second, resuscitation efforts require numerous providers to work in close proximity to one another and the patient. Finally, these are high-stress emergent events in which the immediate needs of the patient requiring resuscitation may result in lapses in infection-control practices.^[1]

Will the changes decrease chances of successful resuscitation?

Yes. That is unavoidable, but DNRs (Do Not Resuscitate orders) and POLSTs (Physicians Orders for Life Sustaining Treatment) also decrease the chances of successful resuscitation. These changes are still the right thing to do.

How do these changes decrease the chances of successful resuscitation?

There is more focus on successful intubation – at the expense of continuous chest compressions. Chest compressions definitely improve outcomes, while there is no evidence that intubation improves outcomes – and there is evidence that intubation decreases successful resuscitation.

Prioritize oxygenation and ventilation strategies with lower aerosolization risk

● Use a HEPA filter, if available, for all ventilation
● Intubate early with a cuffed tube, if possible, and connect to mechanical ventilator, when able
● Engage the intubator with highest chance of first-pass success
● Pause chest compressions to intubate
● Consider use of video laryngoscopy, if available
● Before intubation, use a bag-mask device (or T-piece in neonates) with a HEPA filter and a
tight seal
● For adults, consider passive oxygenation with nonrebreathing face mask as alternative to bagmask device for short duration
● If intubation delayed, consider supraglottic airway
● Minimize closed circuit disconnections^[1]

The AHA is now telling us to stop compressions to help minimize the number of intubation attempts, but not because intubation is going to improve outcomes for the patient. This is to protect everyone near the patient from aerosolized infectious material. An endotracheal tube with a HEPA filter is not an absolute protection, but intubation with a HEPA filter is probably best at preventing spread of aerosolized infectious material than other methods of ventilation and probably even better than passive ventilation (compression only resuscitation with a mask over the patient’s mouth).

Because our patients will now have a lower chance of a good outcome (being resuscitated with good brain function), we should also be more selective about whom we attempt to resuscitate. Too many of us have only been going through the motions, because we have refused to recognize futility, or our medical directors have refused to let us recognize futility.

Even though this lower chance of a good outcome is still better than before we focused on chest compressions, more patients should not have resuscitation attempted.

Consider resuscitation appropriateness

● Address goals of care
● Adopt policies to guide determination, taking into account patient risk factors for survival ^[1]

The other import consideration is the transport of family members.

Transport

o Family members and other contacts of patients with suspected or confirmed COVID-19 should not ride in the transport vehicle.
o If return of spontaneous circulation (ROSC) has not been achieved after appropriate resuscitation efforts in the field, consider not transferring to hospital given the low likelihood of survival for the patient,¹⁷ balanced against the added risk of additional exposure to prehospital and hospital providers.^[1]

Unfortunately, footnote 17 is to page 16 of CARES (the Cardiac Arrest Registry to Enhance Survival), which is about using CARES in Ohio. I suspect that this was meant to refer to something else, so the wrong citation was provided in the rush to get new guidelines on line quickly.

17. CARES: Cardiac Arrest Registry to Enhance Survival. 2018 Annual Report.

https://mycares.net/sitepages/uploads/2019/2018_flipbook/index.html?page=16

Below are all of the new AHA algorithms (they are also available in PDF format at
https://www.ahajournals.org/doi/pdf/10.1161/CIRCULATIONAHA.120.047463

AHA – COVID-19 Recommendations – BLS Healthcare Provider Adult Cardiac Arrest Algorithm ^[1]

Click on the image for full size.

AHA – COVID-19 Recommendations – ACLS Cardiac Arrest Algorithm ^[1]

Click on the image for full size.

AHA – COVID-19 Recommendations – BLS Healthcare Provider Pediatric Cardiac Arrest Algorithm for 2 or More Rescuers ^[1]

Click on the image for full size.

AHA – COVID-19 Recommendations – BLS Healthcare Provider Pediatric Cardiac Arrest Algorithm for the Single Rescuer ^[1]

Click on the image for full size.

AHA – COVID-19 Recommendations – PALS Pediatric Cardiac Arrest Algorithm ^[1]

Click on the image for full size.

Footnotes:

^[1] Interim Guidance for Basic and Advanced Life Support in Adults, Children, and Neonates With Suspected or Confirmed COVID-19: From the Emergency Cardiovascular Care Committee and Get With the Guidelines®-Resuscitation Adult and Pediatric Task Forces of the American Heart Association in Collaboration with the American Academy of Pediatrics, American Association for Respiratory Care, American College of Emergency Physicians, The Society of Critical Care Anesthesiologists, and American Society of Anesthesiologists: Supporting Organizations: American Association of Critical Care Nurses and National EMS Physicians.
Edelson DP, Sasson C, Chan PS, Atkins DL, Aziz K, Becker LB, Berg RA, Bradley SM, Brooks SC, Cheng A, Escobedo M, Flores GE, Girotra S, Hsu A, Kamath-Rayne BD, Lee HC, Lehotzky RE, Mancini ME, Merchant RM, Nadkarni VM, Panchal AR, Peberdy MAR, Raymond TT, Walsh B, Wang DS, Zelop CM, Topjian A.
Circulation. 2020 Apr 9. doi: 10.1161/CIRCULATIONAHA.120.047463. [Epub ahead of print]
PMID: 32270695

Free Full Text from the American Heart Association in PDF format

This page is the abstract from the American Heart Association. It has a tab for PDF/EPUB, but the link only provides the PDF link above.

Filed Under: ACLS, Airway Management, Cardiac Arrest, COVID-19, DNR, Ethics, Heresy, PALS, Pharmacology, Resuscitation Theater, Toxicology

Association of ventilation with outcomes from out-of-hospital cardiac arrest

Wed, 31 Jul 2019 11:00:38 -0400 by Rogue Medic

Does this study compare chest compressions with pauses for ventilation (regular CPR [CardioPulmonary Resuscitation]) against continuous chest compressions with no ventilations (compression-only CPR)?

Absolutely not.

This only compares compressions with pauses for good ventialtions against compressions with pauses for bad ventilations.

Will this be used to justify including ventilations in CPR, in spite of the absence of any valid evidence that ventilations improve outcomes?

Yes. It already has in the editorial about the study, published in the same issue.^[1]

The authors of the paper were clear about the actual comparison in the discussion.

Why did so few patients in our study receive ventilation during CPR? Ventilation with a BVM device is a difficult skill to perform properly and must be practiced to maintain proficiency.²² The person performing ventilation must extend the neck, or place an oral airway, and/or perform a jaw thrust maneuver in order to maintain an open airway, a tight mask seal on the face must be maintained to prevent air from leaking around the mask, and the rescuer must then simultaneously squeeze the manual ventilator over 1 to 1.5 s. Our study showed no significant difference in the number of pauses between Group 1 and Group 2 patients (11 vs. 12 pauses). However, Group 2 patients received significantly more ventilations than Group 1 patients (8 vs. 3 ventilations). The study suggests that the rescuers in both Groups attempted ventilation about the same number of times per patient, but these attempts frequently did not result in lung inflation in Group 1 patients.^[2]

In other words, this is a study of 30 compressions with a pause for 2 adequate ventilations to 30 compressions with a pause for 2 inadequate ventilations. This is important to know, but it has nothing to do with compression-only resuscitation.

Were the ventilations in the bad ventilation group going into the stomach? There are not a lot of possibilities, but not much of the ventilations were not going into the lungs or the ventilations were very shallow.

The authors do not mention if there is any difference in the rate of vomiting, aspiration, or other side effects expected from bad ventilation, between the groups.

The authors appear to be measuring the quality of ventilation, which is has never been shown to improve outcomes over compression-only resuscitation.

There is research showing that ventilations do not improve 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.

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Footnotes:

–

^[1] Ventilation during cardiopulmonary resuscitation-Only mostly dead!
Mosesso VN Jr.
Resuscitation. 2019 Aug;141:200-201. doi: 10.1016/j.resuscitation.2019.06.274. Epub 2019 Jun 22. No abstract available.
PMID: 31238035

^[2] Association of ventilation with outcomes from out-of-hospital cardiac arrest.
Chang MP, Lu Y, Leroux B, Aramendi Ecenarro E, Owens P, Wang HE, Idris AH.
Resuscitation. 2019 Aug;141:174-181. doi: 10.1016/j.resuscitation.2019.05.006. Epub 2019 May 18.
PMID: 31112744

Filed Under: Cardiac Arrest, Critical Judgment, EBM, Heresy, Mythology, Research, Resuscitation Theater

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

Tue, 28 Aug 2018 16:05:09 -0400 by Rogue Medic

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

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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, MRes^1,2; Sarah Black, DClinRes²; et al Stephen J. Brett, MD³; Madeleine Clout, BSc⁴; Michelle J. Lazaroo, MSc⁴; Jerry P. Nolan, MBChB^5,6; Barnaby C. Reeves, DPhil⁴; Maria Robinson, MOst²; Lauren J. Scott, MSc^4,7; Helena Smartt, PhD⁴; Adrian South, BSc (Hons)²; Elizabeth A. Stokes, DPhil⁸; Jodi Taylor, PhD^4,5; 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, MS^1,2; Robert H. Schmicker, MS³; Mohamud R. Daya, MD, MS⁴; et al Shannon W. Stephens, EMT-P²; Ahamed H. Idris, MD⁵; Jestin N. Carlson, MD, MS^6,7; M. Riccardo Colella, DO, MPH⁸; Heather Herren, MPH, RN³; Matthew Hansen, MD, MCR⁴; Neal J. Richmond, MD^9,10; 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.

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^[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.

Filed Under: ACLS, Airway Management, Cardiac Arrest, Common Sense, Critical Judgment, Ethics, Heresy, Intubation, Research Blogging, Resuscitation Theater

A Randomized Trial of Epinephrine in Out-of-Hospital Cardiac Arrest – Part I

Thu, 19 Jul 2018 14:40:46 -0400 by Rogue Medic

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

The results are in from the only completed Adrenaline (Epinephrine in non-Commonwealth countries) vs. Placebo for Cardiac Arrest study.

Even I overestimated the possibility of benefit of epinephrine.

I had hoped that there would be some evidence to help identify patients who might benefit from epinephrine, but that is not the case.

PARAMEDIC2 (Prehospital Assessment of the Role of Adrenaline: Measuring the Effectiveness of Drug Administration in Cardiac Arrest) compared adrenaline (epinephrine) with placebo in a “randomized, double-blind trial involving 8014 patients with out-of-hospital cardiac arrest”.

More people survived for at least 30 days with epinephrine, which is entirely expected. There has not been any controversy about whether giving epinephrine produces pulses more often than not giving epinephrine. As with amiodarone (Nexterone and Pacerone), the question has been whether we are just filling the ICUs and nursing home beds with comatose patients.

There was no statistical evidence of a modification in treatment effect by such factors as the patient’s age, whether the cardiac arrest was witnessed, whether CPR was performed by a bystander, initial cardiac rhythm, or response time or time to trial-agent administration (Fig. S7 in the Supplementary Appendix). ^[1]

The secondary outcome is what everyone has been much more interested in – what are the neurological outcomes with adrenaline vs. without adrenaline?

The best outcome was no detectable neurological impairment.

the benefits of epinephrine that were identified in our trial are small, since they would result in 1 extra survivor for every 112 patients treated. This number is less than the minimal clinically important difference that has been defined in previous studies.29,30 Among the survivors, almost twice the number in the epinephrine group as in the placebo group had severe neurologic impairment.

Our work with patients and the public before starting the trial (as summarized in the Supplementary Appendix) identified survival with a favorable neurologic outcome to be a higher priority than survival alone. ^[1]

Click on the image to make it larger.

Are there some patients who will do better with epinephrine than without?

Maybe (I would have written probably, before these results), but we still do not know how to identify those patients.

Is titrating tiny amounts of epinephrine, to observe for response, reasonable? What response would we be looking for? Wat do we do if we observe that response? We have been using epinephrine for over half a century and we still don’t know when to use it, how much to use, or how to identify the patients who might benefit.

I will write more about these results later

We now have evidence that, as with amiodarone, we should only be using epinephrine as part of well controlled trials.

–

Also see –

How Bad is Epinephrine (Adrenaline) for Cardiac Arrest, According to the PARAMEDIC2 Study?

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Footnotes:

–

^[1] A Randomized Trial of Epinephrine in Out-of-Hospital Cardiac Arrest.
Perkins GD, Ji C, Deakin CD, Quinn T, Nolan JP, Scomparin C, Regan S, Long J, Slowther A, Pocock H, Black JJM, Moore F, Fothergill RT, Rees N, O’Shea L, Docherty M, Gunson I, Han K, Charlton K, Finn J, Petrou S, Stallard N, Gates S, Lall R; PARAMEDIC2 Collaborators.
N Engl J Med. 2018 Jul 18. doi: 10.1056/NEJMoa1806842. [Epub ahead of print]
PMID: 30021076

Free Full Text from NEJM

All supplementary material is also available at the end of the article at the NEJM site in PDF format –

Protocol

Supplementary Appendix

Disclosure Forms

There is also an editorial, which I have not yet read, by Clifton W. Callaway, M.D., Ph.D., and Michael W. Donnino, M.D. –

Testing Epinephrine for Out-of-Hospital Cardiac Arrest.
Callaway CW, Donnino MW.
N Engl J Med. 2018 Jul 18. doi: 10.1056/NEJMe1808255. [Epub ahead of print] No abstract available.
PMID: 30021078

Free Full Text from NEJM

Filed Under: 2018 ACLS Guidelines, ACLS, Common Sense, Critical Judgment, Drug Shortages, Epinephrine, Ethics, Evidence, Heresy, Intubation, Lasix, Mythology, Narrative Fallacy, Oxygen, Pharmacology, Placebo, Potentially Reversible Causes, Probability, Research, Research Blogging, Resuscitation Theater, tPA

Dr. Kudenchuk is Misrepresenting ALPS as ‘Significant’

Tue, 12 Apr 2016 17:00:18 -0400 by Rogue Medic

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.

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

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^[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.

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^[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

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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

Filed Under: Cardiac Arrest, Critical Judgment, EBM, Evidence, Heresy, Pharmacology, Research Blogging, Resuscitation Theater

Amiodarone, Lidocaine, or Placebo in Out-of-Hospital Cardiac Arrest

Mon, 04 Apr 2016 18:15:53 -0400 by Rogue Medic

I wrote about the start of the ALPS (Amiodarone, Lidocaine, Placebo Study) in 2012^[1] and the results are now in.

In this randomized, double-blind, placebo-controlled, prehospital trial, we found that treatment with amiodarone or lidocaine did not result in a significantly higher rate of survival to hospital discharge or favorable neurologic outcome at discharge than the rate with placebo after out-of-hospital cardiac arrest caused by shock-refractory initial ventricular fibrillation or pulseless ventricular tachycardia. There were also no significant differences in these outcomes between amiodarone and lidocaine.^[2]

The primary endpoint is that amiodarone does not improve survival to discharge and neither does lidocaine. However, the results are a bit more complicated than just throw out the drugs.

Two subgroups did have better outcomes, but as the authors appropriately point out, subgroup analysis requires a higher level of significance, because you are essentially getting extra shots at the goal for every subgroup. The more subgroups we have, the more likely that one of them will reach the p value of <0.05.

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.^[2]

Another important point is that the possibility of an effect was probably overestimated by the researchers. A much larger study would be needed to show this smaller effect.

Finally, the point estimates of the survival rates in the placebo group and the amiodarone group differed less than anticipated when the trial was designed, which suggests that the trial may have been underpowered. If amiodarone has a true treatment effect of 3 percentage points, approximately 9000 patients across the three trial groups would be needed to establish this difference in outcome with 90% power. Though seemingly small, a confirmed overall difference of 3 percentage points in survival with drug therapy would mean that 1800 additional lives could be saved each year in North America alone after out-of-hospital cardiac arrest.^[2]

How could the top doctors in the field be so far off in their estimate?

We dramatically overestimate the good we do and we dramatically underestimate the harm we do. We are unreasonably optimistic.

Image credit.

We still do not have any evidence that anything other than compressions and defibrillation improve outcomes for adult patients with cardiac arrest, but we insist on using these treatments, because we believe in magic pills.

Should we consider giving amiodarone or lidocaine to only witnessed cardiac arrest patients or only EMS-witnessed cardiac arrest? Yes, but that is really just limiting the use of these drugs to those who have some weak evidence of benefit.

We are already giving too many treatments to too many patients, based on too little evidence.

That is assuming that we have any valid evidence at all. Medical ethics appears to be only for other people, because we don’t care enough to find out if our treatments work. We just make excuses for the harm we cause to our patients.

–

Footnotes:

–

^[1] What Will Be the Next Standard Of Care We Eliminate
Wed, 28 Mar 2012
Rogue Medic
Article

–

^[2] Amiodarone, Lidocaine, or Placebo in Out-of-Hospital Cardiac Arrest
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

Filed Under: Pharmacology, Research Blogging, Resuscitation Theater

Narcan in Cardiac Arrest – Safe as Long as I Don’t Understand Safety

Tue, 13 Jan 2015 23:30:47 -0500 by Rogue Medic

How can I justify exposing patients to the risks of a treatment that has no known benefit?

Here is one way –

I give Narcan in arrest. You might not. Neither of us are wrong. Yet.

Narcan (naloxone) is one of the safer drugs we use. Suppose that I give a drug in a way that has not been found to be beneficial because I think it is safe as long as I can’t think of a specific problem I can cause. Does that make the inappropriate drug administration safe? Or is it just an example of my ignorance?

If a lack of knowledge were a good thing, we should not teach anything about pharmacology.

The less I know, the safer it is. Ignorance is safety.

We should not teach about the adverse effects of drugs, because as long as I don’t know about the danger, there is no danger. It is only after the danger is known that the danger is real, so don’t tell me about any dangers.

In the ACLS (Advanced Cardiac Life Support) guidelines, the American Heart Association tells us that it is wrong to give Narcan during cardiac arrest.

Naloxone is a potent antagonist of the binding of opioid medications to their receptors in the brain and spinal cord. Administration of naloxone can reverse central nervous system and respiratory depression caused by opioid overdose. Naloxone has no role in the management of cardiac arrest.^[1]

Naloxone has no role in the management of cardiac arrest.

Why did I give Narcan? Because ACLS told me not to.

Don’t think, just do something. If I do not know of a danger, there is no danger. If I have been told that it is wrong, do it anyway.

Image credits – 1 – 2 – 3

Repeat the mindless sequence as often as necessary, until the desire to understand patient care has been destroyed.

But Narcan reverses respiratory depression and apnea.

Narcan can reverses respiratory depression or apnea in a living patient. A patient in cardiac arrest due to a heroin overdose should be treated for a respiratory cause of cardiac arrest. Children and patients with respiratory causes of cardiac arrest should be ventilated and oxygenated. These patients will also be receiving epinephrine (Adrenaline in Commonwealth countries) in the early part of the standard treatment of cardiac arrest. Narcan does not add anything to these treatments the patient is already receiving.

But Narcan is safe – and I can’t make the patient any worse.

Naloxone is one of the safer drugs we can give to a patient when there is an indication to give naloxone. Even when given inappropriately, naloxone is not very likely to cause harm.

There are several problems.

If I am pushing drugs because I don’t know what to do, I should be trying to figure out what treatments I can give that might actually help the patient. There is no reason to believe that naloxone might actually help the patient. If I am giving drugs that provide no benefit, I am distracting myself from assessment, which might provide information that can help me resuscitate the patient.

As long as I don’t know what I’m doing, I am not wrong.

No.

As long as I don’t know what I’m doing, I am both wrong and dangerous.

Reducing Interruptions – How To Send The Wrong Message

Thu, 14 Jan 2010 19:09:30 -0500 by Rogue Medic

The less time off the chest, the better the results for the victim of out-of-hospital cardiac arrest. Educating EMS providers in performing high-quality CPR possible is crucial. (Photo Ryche Guerrero)^[1]

JEMS has a good article, and it is on an important topic, but whoever decided to use the picture (above) that accompanies the article needs to cut back on the use of the crack pipe, just a little bit, or maybe just cut back while at work.

The article is about the importance of quality in the performance of chest compressions, but the picture seems to have been staged to demonstrate as many errors as possible. Maybe this is not at all representative of what this crew normally does, but somebody should have looked at it, giggled let out a heavy sigh of despair, and looked for something that does not contradict the message of the article.

Is this a trauma code? The immobilization may be a part of the movement by some in EMS to have us put collars on intubated patients, rather than have us pay attention to the way we move patients. If the goal is to just prevent the tube from being dislodged, we should not tape the head down as, well. The collar does not make a dislodged tube impossible, so if the tube is dislodged, now (depending on the amount and type of tape used) we might wish we hadn’t applied tape.

So I will assume that this is a trauma code, which raises the question – What century are we in? Why are we doing compressions on a trauma code? Why are we transporting a trauma code?

We have four people and a dead body. Each is in his/her own little world, doing his/her own little thing.

Someone behind the door is bagging the patient through the endotracheal tube, because this is about how much more important compressions are than ventilations.

Monitor Guy is doing something monitorish, because otherwise there might not be anything to do – except relieve the guy attempting compressions.

Headset Guy appears to be pushing drugs, because drugs have not been shown to improve outcomes in cardiac arrest.

Headset? Why do we have headsets? Well, it appears that the fashionable attire of Monitor Guy and Headset Guy includes some dandy little flight patches. So, not only does this appear to be an inappropriate transport of a dead guy, but it appears to be an inappropriate flight of a dead guy. On the plus side, the flight is not for mechanism only. Lemonade anyone?

Maybe the flight crew was called for the patient while the patient was still alive and they are only assisting the ambulance crew to the ambulance with the patient. Nobody flies dead people, at least not in this century. Right? Or should this flight service be known as Corpse Flight – nobody is too dead for low altitude at high prices!

One guy left. The guy who is actually doing compressions. Maybe I shouldn’t use the words actually, or doing, since at the angle demonstrated, Arnold Schwarzenegger would have trouble generating effective compressions.

But we don’t have a better way of performing compressions while loading the patient in the ambulance, for the ride to the landing zone, for the flight to the helipad, for the elevator ride(s) (or is it another ambulance ride) to the ED, where someone may feel the need to continue the code for a little while, just to avoid hurting the feelings of everyone who has worked so hard to get him here.

This is resuscitation theater, not medicine.

This is not about the patient, but about putting on a show – and in this case it does not even appear to be a good show.

Why are we endangering all of these people, just to put on a show? Ground crews deserve better. Flight crews deserve better.

Compressions are important. Interruptions in compressions lead to worse outcomes.

it’s clear that educating EMS providers in performing the best quality CPR possible and monitoring those efforts to ensure that these skills are not deteriorating over time is also a crucial component that EMS systems need to direct time and resources to in order to increase OOHCA saves.^[1]

I think this is a picture of an interruption of compressions.

This is not CPR.

Is this anything other than just going through the motions?

Educating EMS providers in performing high-quality CPR possible is crucial.^[1]

And it should be continuous.

Footnotes:

^ ¹ Reducing Interruptions – Continuous chest compression CPR and minimally interrupted CPR result in improved survival
By David P. Keseg, MD, FACEP
2010 Jan 1
JEMS.com
Article

Updated Article Link 7-15-10

The article was also selected by JEMS as one of its Best of JEMS series, where they chose what they believe to be their best article of the year. This is their choice for 2010 – as of the Ides of March, 2010. Late addition – 7-15-10 19:48

Filed Under: Helicopters, Heresy, Resuscitation Theater Tagged With: Helicopters, Heresy, Resuscitation Theater

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

Interim Guidance for Basic and Advanced Life Support in Adults, Children, and Neonates With Suspected or Confirmed COVID-19 – April 9, 2020

Association of ventilation with outcomes from out-of-hospital cardiac arrest

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

A Randomized Trial of Epinephrine in Out-of-Hospital Cardiac Arrest – Part I

Dr. Kudenchuk is Misrepresenting ALPS as ‘Significant’

Amiodarone, Lidocaine, or Placebo in Out-of-Hospital Cardiac Arrest

Narcan in Cardiac Arrest – Safe as Long as I Don’t Understand Safety

Reducing Interruptions – How To Send The Wrong Message

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