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

- Rogue Medic

Safety and Effectiveness of Field Nitroglycerin in Patients with Suspected ST Elevation Myocardial Infarction

Mon, 12 Aug 2019 17:46:11 -0400 by
 

Is prehospital use of NTG (NiTroGlycerin; GTN GlycerylTriNitrate in Commonwealth countries) safe for treating prehospital suspected STEMI (ST segment Elevation Myocardial Infarction) patients?

The evidence is limited, but does not suggest that prehospital NTG produces enough harm to discourage use in suspected STEMI. These researchers looked at the emergency department assessments of patients following prehospital NTG for suspected STEMI.  

Despite the theoretical risk, the limited retrospective studies of NTG in the prehospital setting for multiple indications suggest that the medication is safe.(10-13) However, with regard to NTG use for STEMI, the AHA International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care concluded that there was not enough evidence to determine the benefit or harm of out-of-hospital use of NTG.(14) Given the high false positive rates for STEMI identified in the field, an additional concern is that many patients treated with NTG for presumed STEMI will ultimately have an alternate etiology for their pain.(15, 16) Therefore, it is not clear that the benefits outweigh the risks of administering NTG to all patients with suspected STEMI in the field.[1]
 

This paper helps to show the safety of prehospital NTG for suspected STEMI, providing evidence that blood pressure changes were similar in suspected STEMI patients with an SBP (Systolic Blood Pressure) of 100, or higher, regardless of whether they were treated with NTG. The study is a retrospective chart review, so we do not know why some of the patients were not treated with NTG.

One reason mentioned, but not discussed, is that only 22% (96 of 440) suspected STEMI patients not treated with NTG are documented to have had pain, but there is no information on the type of pain or other cardiac symptoms of the patients. Were the paramedics avoiding treating atypical chest pain, such as pressure, heaviness, gastric discomfort, difficulty breathing, et cetera? We do not know. Was only chest pain being documented, rather than shoulder, or arm, or jaw, pain? We do not know. Did the pain resolve prior to EMS arrival? We do not know. Were the paramedics correctly recognizing when the machine interpretation of the ECGs (ElectroCardioGrams) were wrong? We do not know.

The median Initial Pain Score is documented as 8, with an IQR (Inter-Quartile Range) of 5-9 for those treated with NTG. For those not treated with NTG the Initial Pain Score is documented as 0, with an IQR of 0-0. We do not know the Initial Pain Score of those who did have pain, but were not treated with NTG. All of these patients were in an IQR that was not documented in the paper. The good news is that the suspected STEMI patients not treated with NTG act as a control group, although possibly with important differences that are not discussed in the paper.

Click on the image of the LA County protocol to make it larger.[2]

What about the 17% of suspected STEMI patients with SPB <100 mmHg who were treated with NTG?

Was medical command (California has certified MICNs [Mobile Intensive Care Nurses] providing medical command on the radio, with physicians available, as well) contacted for authorization to deviate from the protocol? If so, that is something that should be documented in the charts, which were reviewed for this paper. That information is not included in this paper. Those patients are much more interesting to me.

I do not object to using NTG to treat suspected STEMI with an SBP below 100 mmHg, but the authors seem to think that EMS should not even consider it. Do the outcomes of those patients support the approach of the authors? We do not know.

I suspect that the fears of bottoming out the blood pressure are very exaggerated, but it would be nice to have some evidence either way.

An important secondary end point was the differences between those with inferior/right ventricular STEMI, but treated with NTG.  

By vasodilating all blood vessels, and the venous system in particular, it causes a drop in blood pressure and preload. Thus, there is concern for precipitating hypotension in ACS involving the right ventricle.(1-3) Contraindications to the use of NTG, as outlined by the American Heart Association (AHA) Guidelines on the treatment of ACS, include right ventricular infarction.(4) This raises concern for use in inferior ST-segment elevation myocardial infarction (STEMI) in the prehospital setting, since many inferior STEMI result from proximal right coronary artery (RCA) occlusion and 50% involve the right ventricle.(3) Traditional 12-lead ECG is focused mainly on the left side of the heart and typically EMS protocols do not include acquisition of right-sided ECG leads. Further, in many systems, Basic Life Support (BLS) protocols allow for administration of NTG without differentiating the location of STEMI. There is also risk of other adverse events including bradycardia and cardiac arrest.(5-9)[1]
 

I have aggressively promoted the use of NTG for even hypotensive CHF/ADHF (Congestive Heart Failure/Acute Decompensated Heart Failure). Many physicians are not comfortable with that, even though the available evidence shows that aggressive IV NTG doubled the survival rate for these hypotensive patients. More research is needed on the use of NTG, especially in hypotensive patients.  

Further, we did not find an increased risk of hypotension among patients with proximal or mid RCA occlusions confirmed on coronary angiography. There are several possible reasons for our findings. First, while right ventricular involvement in inferior STEMI is common, hemodynamic instability is actually rare due to the right ventricle’s more favorable oxygen supply-demand ratio compared to the left heart and more extensive collateral flow.(3, 22) In addition, left heart occlusions may also involve the right ventricle and result in a preload dependent condition.(23-25) While limited by sample size, our results suggests that specifically avoiding NTG use in inferior STEMI, which is common in EMS systems, may be misguided. One quarter of the local EMS agencies in the state of California, for example, currently prohibit the use of NTG in inferior STEMI.(26) This analysis would benefit from additional study with a larger sample size and specific information about the infarct territory. Further studies are needed to determine which patients, in particular, are at increased risk for hypotension when treated with NTG.[1]
 

Perhaps NTG is also safe for treating patients with inferior ischemia and even right ventricular ischemia.

Footnotes:

[1] Safety and Effectiveness of Field Nitroglycerin in Patients with Suspected ST Elevation Myocardial Infarction.

Bosson N, Isakson B, Morgan JA, Kaji AH, Uner A, Hurley K, Henry TD, Niemann JT.

Prehosp Emerg Care. 2018 Dec 17:1-9. doi: 10.1080/10903127.2018.1558318. [Epub ahead of print]

PMID: 30556765

[2] Treatment Protocol: Chest Pain */ Acute MI

Reference No. 1244

LA County Paramedic Protocols

Los Angeles County Department of Health Services – Emergency Medical Services

Protocol

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Filed Under: ACLS, ACS, Assessment, Cardiology, Chest Pain, Critical Judgment, EBM, Evidence, GTN, Heresy, NTG, Research, RVI

Protecting Systemic Incompetence – Part I

Thu, 28 Feb 2019 15:01:12 -0500 by

We demand the lowest standards, because we are willfully ignorant and we do not want to understand. The surprise is that so many of us survive our devotion to incompetence. The loudest voices tend to dominate the discussions and the loudest voices demand that their excuses for incompetence be accepted. The rest of us don’t oppose incompetence enough.

A nurse was told to give 2 mg Versed (the most common brand of midazolam in the US) for sedation for a scan, intended to give 1 mg Versed, but actually gave an unknown quantity of vecuronium (Norcuron is the most common brand in the US). The patient was observed to be unresponsive and pulseless by the techs in the scan. A code was called. The family learned the details from a newspaper article, not from the hospital.

A Tennessee nurse charged with reckless homicide after a medication error killed a patient pleaded not guilty on Wednesday in a Nashville courtroom packed with other nurses who came in scrubs to show their support.[1]

The nurse intended to give a medication that should be limited to patients who are monitored (ECG and waveform capnography), because different patients will respond in different ways. This is basic drug administration and deviation from that basic competence may even have been common in this Neuro ICU (Neurological Intensive Care Unit). We demand low standards, because we do not want to understand.

We don’t need to monitor for that, because that almost never happens.

Except these easily preventable errors do happen. And we lie about it. We help to cover it up, because we demand low standards, regardless of how many patients have to suffer for the benefit of our incompetence.

This is a common argument used by doctors, nurses, paramedics, . . . . It makes no sense, but we keep demonstrating that we don’t care.

The people in charge should act responsibly, but they delegate responsibility and we reward them.

Back to the hospital, Vanderbilt University Medical Center (VUMC) is a university medical center, so the standards should be high. VUMC was founded in 1874 and is ranked as one of the best hospitals in America.

There is a drug dispensing machine, from which less-than-skilled nurses can obtain almost anything and administer almost anything, without understanding enough to recognize the problem. This is an administrative problem. This was designed by someone with no understanding of risk management.

The over-ride of the selection is not the problem, because emergencies happen and it is sometimes necessary to bypass normal procedures during an emergency. Ambulances are equipped with lights, sirens, and permission to violate certain traffic rules for this reason.

Some of the many blatant problems are:

* The failure of the nurse to have any understanding of the medication supposed to be given

* The failure of the nurse to recognize that the drug being given was not the drug ordered.

* The failure of the nurse to monitor the patient being given a drug for sedation.

* Most of all, the failure of the hospital – the nurses, the doctors, the administrators, to try to make sure that at least these minimum standards are in place.

* How often do nurses in the Neuro ICU give midazolam?

* Why is a nurse, who is clearly not familiar with midazolam, giving midazolam to any patient?

* How is a nurse, working unsupervised in a Neuro ICU not familiar with midazolam?

* What kind of qualifications are required for a nurse to give sedation without supervision?

* Since this nurse was orienting another nurse, what qualifies this nurse to orient anyone?

* Given the side effects of midazolam, why was midazolam ordered without monitoring?

* Given the side effects of midazolam, was it the most appropriate sedative for use in a setting where monitoring is going to be difficult?

* Was it the more rapid onset of sedation, in order to free up the PET scan more quickly and/or avoid having to reschedule the scan, that led to the choice of midazolam?

* How well do any of the doctors understand the pharmacology of midazolam if they are giving orders for a nurse to grab a dose, take it down to the scan, give the drug, and return to the unit, abandoning the monitoring of the patient to the techs in the PET scan?

* This is not a criticism of the techs in PET scan, but are techs authorized to manage sedated patients?

* Even though they will often scan sedated patients, are the techs required to demonstrate any competence at managing sedated patients?
The nurses being oriented apparently thought that it is customary to give sedation:

1. without even looking at the name of the medication

2. without confirming by looking at the name again, it before administration

3. without double checking with a nurse, or tech, that the label matches the name of the drug to be given
How many of the doctors, responsible for the care of ICU patients, would agree to be sedated, without being monitored, and to have their care handed off to PET scan technicians?

Why didn’t the doctors and nurses see this as a problem before it made the news?

If the problems were reported, nothing appears to have been done to address the problems beyond the usual – Nothing to see here. Move along. or That’s above your pay grade.

That is the primary point I am trying to make.

The problem is well above the pay grade of the nurse.
Here is the part that experienced nurses have jumped on immediately:

Why did the nurse think that midazolam needs to be reconstituted?

Vecuronium (most common brand name is Norcuron) is a non-depolarizing neuromuscular-blocker, which comes as a powder, that needs to be reconstituted.

Image source
1. Read label instructions?

This nurse has repeatedly demonstrated a need to be supervised, but those responsible for that supervision have apparently ignored their responsibilities in a way that far exceeds any failures by this nurse.

Is it possible that this is a one time event and that the nurse has behaved in an exemplary manner at all times while around doctors and other nurses before this day? It is possible, but the number and severity of the failures on the part of the nurse strongly suggest a pattern of not understanding, not caring, or both. I suspect that any lack of caring is due to a lack of understanding, because I have not yet lost all hope in humanity.

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Footnotes:

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[1] Nurse charged in fatal drug-swap error pleads not guilty
By Travis Loller
February 20, 2019
Associated Press
Article

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Edited 3/24/2022 at 00:34 to correct spelling from less-than-killed to less-than-skilled and poweder top powder.

Filed Under: Appearances, Assessment, Ethics, Experience, Heresy, Legal Medicine, Malpractice, Midazolam, Mythology, Pharmacology, Risk Management, Rules of safe drug administration, Sedation, Waveform Capnography

This Rhythm is Hilarious

Fri, 04 Jan 2019 12:46:23 -0500 by
 


Click on the image to make it larger.
 

Apparently, the second 12 lead was after 150 mg of amiodarone. The hilarity is the amiodarone.

I received this in an email. It is reported to have been posted on Facebook, but I choose not to have access to Facebook, so I do not have any more details. I am occasionally tempted to set up an account again, but I generally prefer intentional comedy.

Everything you need to know is in the first 12 lead.

Things that do not matter:

Distance to the hospital.

Time of onset.

Last meal.

National Registry certification.

Et cetera.

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Filed Under: ACLS, Assessment, Cardiology, Critical Judgment, Heresy, Pharmacology, Placebo, Understanding, V Tach

Irresponsibility and Intubation – The EMS Standard Of Care

Wed, 09 Aug 2017 11:00:03 -0400 by
 

There is a petition to save EMS intubation, but it claims to be a petition to save patients. The petition is not to save patients.
 


Image source
Details here and here.
 

The petition states that its intent is to protect patients, but it does not provide any evidence. It only makes the same claims that every other quack makes to promote his snake oil.

We are worse than homeopaths, because homeopaths do not actively harm patients by depriving patients of oxygen, as we do when we intubate.
 

 
We are the quack, witch doctor, homeopath, horseshit peddlers Dara O’Briain is describing.

 

Today we are possibly facing the removal of the most effective airway intervention at our disposal as paramedics, endotracheal intubation.[1]

 

Most effective?

There is some evidence that intubation can be – in limited situations, by highly trained, competent people – beneficial. There is also plenty of evidence that intubation is harmful. It is easy to kill someone by taking away the patient’s airway.

Most effective?

No.

This petition does not mention evidence, so it has no credibility when it comes to claims of whether intubation is effective. This petition expects us to believe in a faerie tale of magical improvement with intubation. This petition wants us to clap for Tinkerbell, because If we believe hard enough, it just might come true. Grow up.
 

Please sign this petition so that these patients have a chance to live[1]

 

Prove that requiring higher standards for intubation would take away a patient’s chance to live.

Prove that intubation improves outcomes.

This is a petition to keep standards low for paramedics.

This petition does not mention competence, or even what is involved in competence, because this petition is opposition to competence.

This is the Protect Incompetent Paramedics from Responsibility Petition.

Responsibility is for professionals. In EMS, we reject responsibility.

We are more concerned with whether our shoes are shiny, than whether we are harming, or helping, our patients. The reason EMS exists is to improve outcomes for patients.

We don’t deliver competent care, but only the appearance of competence. We are medical theater, putting on a fancy show. The TSA (Transportation Security Administration) is the same – all appearance and no substance.

Most effective? Maybe intubation is the most effective theater.

The outcomes of our patients are affected, but we refuse to learn if we are helping, harming, or doing equal amounts of harm and help.

We actually oppose learning. We are willfully ignorant – and proud of our defiant stand for ignorance.

How much hypoxia do we cause in our attempts to place the so called gold standard? The actual gold standard is helping the patient to protect his own airway, but who cares what’s best for the patient? Not those who sign the petition.

How much vomiting, and aspiration, do we cause?

How much airway swelling do we cause?

How many airway infections do we cause?

How much harm do we cause?

We don’t know. We don’t care. We oppose attempts to find out.

We are EMS and we believe that our actions should be protected from examination, because we are beautiful and unique snowflakes who demand our participation trophies without doing real work required to be competent.

Go ahead, snowflakes, demonstrate your incompetence by signing the petition, because this protect intubation petition is really a protect incompetence petition.

If we want to continue to intubate, and we want to improve outcomes for our patients, we need to demonstrate that intubation by EMS provides significant benefit and which patients are most likely to benefit. We can’t do that because we don’t care enough about our patients.
 

Brian Behn has a different reason for not signing the petition for low standards – Why I am Not Signing The Petition About Intubation.

Dave Konig also comments on the petition for low standards – Is ET Intubation Joining Backboards In Protocol?

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Footnotes:

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[1] Allow paramedics to continue to save lives with endotracheal intubation!
Anthony Gantenbein United States
Petition site

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Filed Under: Airway Management, Assessment, Critical Judgment, Education, Evidence, Heresy, Intubation, Malpractice, Risk Management, RSI

D10 in the Treatment of Prehospital Hypoglycemia: A 24 Month Observational Cohort Study

Wed, 31 May 2017 23:59:12 -0400 by
ResearchBlogging.org
 

Why treat hypoglycemia with 10% dextrose (D10), rather than the more expensive, potentially more harmful, and less available, but traditional treatment of 50% dextrose (D50)? Why not? The only benefit of 50% dextrose appears to be that it is what people are used to using, but aren’t we used to starting IVs (IntraVenous lines) and running fluids through the IVs?

We should be much more familiar with running in fluid, than in pushing boluses of syrup.

What happens when we have temporary shortages of 50% dextrose? Do we stop treating hypoglycemia? Are we supposed to panic, because we can no longer follow tradition? No. We give the more appropriate, and lower, dose of the much lower concentration of dextrose. We provide better care because of our need.
 

Despite the traditional use of D50, there is a minimal amount of data to support it as the standard of care.[1]

 

Is 10% dextrose the perfect treatment for hypoglycemia? No, but it does appear to be less likely to cause harm than the current overtreatment with 50% dextrose.
 

Seven patients had a drop in blood glucose after D10 administration, all of 10 mg/dL or less except for one patient with a drop of 19 mg/dL who had an insulin pump infusing that was not removed by EMS personnel during D10 infusion.[1]

 

Is that any different from what happens with 50% dextrose? If this is different from D50, how does the potential harm from giving too much dextrose to most hypoglycemic patients compare to the potential harm of giving a first that is too small to fewer than 1% of hypoglycemia patients?
 

There were no reported adverse events related to dextrose infusion. Six patients who received intravenous D10 were pronounced dead in the field during the period of study. On investigator review, all patients had altered level of arousal or were in cardiac arrest prior to arrival of EMS personnel and their deaths were deemed to be unrelated to dextrose administration.[1]

 

Dextrose does not reverse death, so there is no reason to expect a better outcome for dead patients with a higher concentration of a drug that does not reverse death. Go read the excellent review of the evidence on hypoglycemia, death, and the potential of dextrose to improve outcomes from death.[2]

But is 10% really better? We don’t have any good research, but is there any good reason to give all 25 grams of dextrose in a syringe of 50% dextrose if the patient wakes up before the full dose has been administered? Would we continue to give the entire syringe of morphine, or fentanyl, or most of the other drugs that we give, if our assessment shows that the patient no longer meets the protocol criteria for administration of the drug?
 


 

76% of patients received only 10 grams of dextrose, rather than the usual 25 grams. While it is not known if any of these patients required any further dextrose, or oral glucose, while in the hospital, they should have been awake enough to take any further dextrose orally, as they would the rest of the time.

23% of patients received only 20 grams of dextrose, rather than the usual 25 grams.

Fewer than 1% of hypoglycemia patients received a dose as large as we traditionally give.
 

We do not appear to be concerned with harm from administering more aggressive treatment than is justified by the evidence.

We do appear to be concerned about our anxiety of deviating from the traditional too much is not enough approach to hypoglycemia.

–

Footnotes:

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[1] D10 in the Treatment of Prehospital Hypoglycemia: A 24 Month Observational Cohort Study.
Hern HG, Kiefer M, Louie D, Barger J, Alter HJ.
Prehosp Emerg Care. 2017 Jan-Feb;21(1):63-67. doi: 10.1080/10903127.2016.1189637. Epub 2016 Dec 5.
PMID: 27918858
 

Of the 1,323 patients administered D10 during the study period, the 452 patients excluded from the study cohort for the aforementioned reasons were similar demographically to the study cohort. The median initial blood glucose was the same at 37 mg/dL and the median age was also 66. There were slightly more women at 229 (51%) in the excluded group compared to the cohort.

 

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[2] Using Dextrose in Cardiac Arrest
Wednesday, March 14, 2012
Mill Hill Ave Command
Dr. Brooks Walsh
Article

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Hern, H., Kiefer, M., Louie, D., Barger, J., & Alter, H. (2016). D10 in the Treatment of Prehospital Hypoglycemia: A 24 Month Observational Cohort Study Prehospital Emergency Care, 21 (1), 63-67 DOI: 10.1080/10903127.2016.1189637

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Filed Under: ALS, Assessment, Critical Judgment, Dextrose, Evidence, Heresy, Research Blogging

Does use of Lights and Sirens save lives?

Tue, 07 Feb 2017 16:00:21 -0500 by
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

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

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[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

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Filed Under: Assessment, Cardiac Arrest, Critical Judgment, Driving, Evidence, Heresy, Risk Management, Traffic

‘Narcan by Everyone’ Does Not Seem to be Such a Good Idea

Thu, 22 Dec 2016 22:45:48 -0500 by
 
Now that we have almost everyone giving naloxone (Narcan) to suspected heroin overdose patients, the fatality rate must have dropped. The panacea must have worked. My criticism of the Narcan by Everyone programs must have made me a laughing stock.[1],[2],[3],[4]

No.

Does that mean that I am a prophet and that you should worship me?

No.

Explanations exist; they have existed for all time; there is always a well-known solution to every human problem — neat, plausible, and wrong. H.L. Mencken.

I have been pointing out that the plans assumed that there would not be any unintended consequences. I explained what some of the unintended consequences would be. Many people used logical fallacies to justify ignoring the likelihood of unintended consequences. The reasonable thing to do would have been to study the implementation, so that problems would be noticed quickly.

Misdiagnosis – giving naloxone to people who have a change in level of consciousness that is not due to an opioid (heroin, fentanyl, carfentanyl, . . . ) overdose.
 

Six of the 25 complete responders to naloxone (24%) ultimately were proven to have had false-positive responses, as they were not ultimately given a diagnosis of opiate overdose. In four of these patients, the acute episode of AMS was related to a seizure, whereas in two, it was due to head trauma; in none of these cases did the ultimate diagnosis include opiates or any other class of drug overdose (which might have responded directly to naloxone). Thus, what was apparently misinterpreted as a response to naloxone in these cases appears in retrospect to have been due to the natural lightening that occurs with time during the postictal period or after head trauma.[5]

Bold highlighting is mine.

 

Failure to ventilate – not providing ventilations to a patient who is not breathing. These patients are often hypoxic (don’t have enough oxygen to maintain life) and hypercarbic (have too much carbon dioxide to maintain life). If the patient is alive, ventilation should keep the patient alive, even if naloxone is not given or if the naloxone is not effective. If the patient is dead, giving naloxone will not improve the outcome.[6]

But . . . But . . . But . . . Narcan is the miracle drug!
 


Image credit.
 

In Akron, a small Ohio city, medical examiner Dr. Lisa Kohler has seen over 50 people die of carfentanil since July. Police Lieutenant Rick Edwards says his officers are “giving four to eight doses of [naloxone] just to get a response.”[7]

 

“Every day our paramedics start CPR on someone surrounded by empty naloxone vials… people give the naloxone and walk away,” she (Ambulance Paramedics of BC president Bronwyn Barter) said in an interview.[7]

 

Where should we start?
 

All patients considered to have opioid intoxication should have a stable airway and adequate ventilation established before the administration of naloxone.[8]

 

We keep making excuses for solutions that are neat, plausible, and wrong. Why don’t we start acting like responsible medical professionals and do what is best for our patients?
 

Thank you to Gary Thompson of Agnotology for linking to this for me.

Go read Response: ‘What happens when drugs become too powerful for overdose kits’

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Footnotes:

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[1] The Myth that Narcan Reverses Cardiac Arrest
Wed, 12 Dec 2012 20:45:29
Rogue Medic
Article

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[2] Should Basic EMTs Give Naloxone (Narcan)?
Fri, 27 Dec 2013 14:00:22
Rogue Medic
Article

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[3] Is ‘Narcan by Everyone’ a Good Idea?
Tue, 03 Jun 2014 23:00:38
Rogue Medic
Article

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[4] Is First Responder Narcan the Same as First Responder AED?
Wed, 18 Jun 2014 17:15:43
Rogue Medic
Article

–

[5] Acute heroin overdose.
Sporer KA.
Ann Intern Med. 1999 Apr 6;130(7):584-90. Review.
PMID: 10189329 [PubMed – indexed for MEDLINE]

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[6] The Kitchen Sink Approach to Cardiac Arrest
Mon, 16 Feb 2015 16:00:53
Rogue Medic
Article

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[7] What Happens When Drugs Become Too Powerful for Overdose Kits?
Dr. Blair Bigham
Oct 4 2016, 12:11pm
Article

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[8] Naloxone for the Reversal of Opioid Adverse Effects
Marcia L. Buck, PharmD, FCCP
Pediatr Pharm. 2002;8(8)
Medscape (free registration required?)
Clinical Uses

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Filed Under: Airway Management, Assessment, Critical Judgment, Fentanyl, Heresy, Heroin, Naloxone, Narcan, Pharmacology, Research, Risk Management

The PROCAMIO Trial – IV Procainamide vs IV Amiodarone for the Acute Treatment of Stable Wide Complex Tachycardia

Wed, 17 Aug 2016 13:30:50 -0400 by
ResearchBlogging.org
 

This is a very interesting trial that may surprise the many outspoken amiodarone advocates, but it should not surprise anyone who pays attention to research.

ALPS showed that we should stop giving amiodarone for unwitnessed shockable cardiac arrest. The lead researcher is still trying to spin amiodarone for witnessed shockable cardiac arrest, even though the results do not show improvement in the one outcome that matters – leaving the hospital with a brain that still works.[1],[2],[3]

There is an excellent discussion of the study on the podcast by Dr. Salim Rezaie and Dr. Anand Swaminathan REBELCast: The PROCAMIO Trial – IV Procainamide vs IV Amiodarone for the Acute Treatment of Stable Wide Complex Tachycardia.

One problem with the study that they do not address on the podcast is that the patients in the study appear to have had time to watch Casablanca before treatment started. Here’s looking at you, while we’re waiting, kid. This is apparently unintentional one way of doing a placebo washout. If we wait long enough . . . .
 

Time from arrival to start of infusion was 87 ± 21 min for procainamide and 115 ± 36 min for amiodarone patients (P = 0.58).[4]

 

If nothing else, this demonstrates how little we need to worry about immediately pushing drugs for stable monomorphic VT (V Tach or Ventricular Tachycardia). Should we expect much from antiarrhythmic treatment?

Research shows that for stable monomorphic VT (V Tach or Ventricular Tachycardia) amiodarone is not very likely to be followed by an improvement. Only 29%[5] or only 25%[6] or only 15% within 20 minutes, but if we don’t mind waiting an hour it can be as much as 29%.[7] For those of you who are not good at math, that means amiodarone is about the same as doing nothing, only it comes in a syringe. Even though these poor outcomes ignore the side effects, they are the best evidence in favor of amiodarone, so what Kool-Aid are the advocates drinking?

Adenosine, yes adenosine the SVT (SupraVentricular Tachycardia) drug, appears to be more effective at treating ventricular tachycardia than amiodarone – and adenosine is faster and safer than amiodarone.[8]

What if the patient becomes unstable? First start an IV (IntraVenous) line. Then sedate the patient. Then apply defibrillator pads. After the patient is adequately sedated, then cardiovert. We do not need the pads on the patient first. If it takes a while to put the pads on, that is a problem with the ability of the doctors and nurses, not a medical problem.

It does not appear as if any patient received amiodarone or procainamide until after waiting in the ED (Emergency Department) for over an hour. Were some patients cardioverted in well under an hour? Probably. The important consideration is that the doctors and nurses be able to apply the defibrillator pads properly and quickly and deliver a synchronized cardioversion in less than a minute. If the patient has not yet been sedated, the cardioversion should be delayed until after the patient is adequately sedated, so the intervention that depends most on time is the sedation of the patient.
 

VT + Amiodarone Cardioversion
 

Is there a better treatment than amiodarone? Sedate the patient before the patient becomes unstable, then cardiovert. How do the MACEs (Major Adverse Cardiac Events) compare with sedation and cardioversion vs. antiarrhythmic treatment.
 

5.4 Proarrhythmia
Amiodarone may cause a worsening of existing arrhythmias or precipitate a new arrhythmia. Proarrhythmia, primarily torsade de pointes (TdP), has been associated with prolongation, by intravenous amiodarone, of the QTc interval to 500 ms or greater. Although QTc prolongation occurred frequently in patients receiving intravenous amiodarone, TdP or new-onset VF occurred infrequently (less than 2%). Monitor patients for QTc prolongation during infusion with amiodarone. Reserve the combination of amiodarone with other antiarrhythmic therapies that prolong the QTc to patients with life-threatening ventricular arrhythmias who are incompletely responsive to a single agent.[9]

 

All antiarrhythmic drugs can cause arrhythmias. In the absence of information about a specific problem that is best addressed by a specific drug (amiodarone is the opposite of specific), we should avoid treatments that have such a high potential for harm.

Amiodarone doesn’t even do a good job of preventing arrhythmias.
 

Intravenous amiodarone did not prevent induction of sustained ventricular tachycardia in any of five patients inducible at baseline. Of six patients with non-sustained ventricular tachycardia, five had sustained ventricular tachycardia or fibrillation induced after amiodarone infusion.[10]

 

Is anything worse than amiodarone? Even epinephrine, yes epinephrine the inadequately tested cardiac arrest drug, has been followed by improved outcomes from V Tach after amiodarone failed.[11]
 

What is best for the patient?

Sedation, search for reversible causes, apply defibrillator pads, and be prepared to cardiovert.

Maybe sedation isn’t that important? This is by Dr. Peter Kowey, one of the top cardiologists in the world.
 

The man’s very first utterance was, “If it happens again, just let me die.”

As I discovered, the reason for this patient’s terror was that he had been cardioverted in an awake state. Ventricular tachycardia had been relatively slow, he had not lost consciousness, and the physicians, in the heat of the moment, had not administered adequate anesthesia. Although the 5 mg of intravenous diazepam had made him a bit drowsy, he felt the electric current on his chest and remembered the event clearly.

The patient’s mental state complicated the case considerably.[12]

 

How unimportant is sedation? How unimportant is consent?

For sedation, I would recommend ketamine, but etomidate was recommended in the podcast. Both work quickly and the most important obstacle to immediate treatment of a patient who suddenly deteriorates is the time to effect of sedation. Neither drug is expected to interfere with perfusion, which is the main excuse given for avoiding sedation for cardioversion.

This study is very small (not the fault of the authors), but it adds to the evidence that amiodarone is not a good first treatment for the patient.
 

Go listen to the podcast by Dr. Salim Rezaie and Dr. Anand Swaminathan REBELCast: The PROCAMIO Trial – IV Procainamide vs IV Amiodarone for the Acute Treatment of Stable Wide Complex Tachycardia

 

Over the years, I have written a bit about cardioversion and the importance of sedation –

Cardioversion – I’m not doing that, you do it! – Mon, 24 Mar 2008

Cardioversion – 2010 ACLS – Part I – Mon, 25 Oct 2010

Cardioversion – 2010 ACLS – Part II – Sun, 31 Oct 2010

Cardioversion – 2010 ACLS – Part III – Thu, 11 Nov 2010

On the relative wisdom of synchronized cardioversion without sedation – Part I – Thu, 11 Nov 2010

On the relative wisdom of synchronized cardioversion without sedation – Part II – Fri, 12 Nov 2010

Synchronized Cardioversion Without Sedation – Part II Scallywag’s Response – Sun, 14 Nov 2010

On the relative wisdom of synchronized cardioversion without sedation – Part III – Tue, 16 Nov 2010

On the relative wisdom of synchronized cardioversion without sedation – Part IV – Wed, 24 Nov 2010

Comments on Cardioversion – 2010 ACLS – Part II – Mon, 16 Apr 2012
 

I have also written a bit about amiodarone –

Merit Badge Courses, Amiodarone, and tPA – Fri, 17 Sep 2010

Amiodarone for Cardiac Arrest in the 2010 ACLS – Part I – Wed, 01 Dec 2010

Amiodarone for Cardiac Arrest in the 2010 ACLS – Part II – Fri, 03 Dec 2010

Is Nexterone the Next Amiodarone? – Sat, 04 Dec 2010

Amiodarone for Cardiac Arrest in the 2010 ACLS – Part III – Mon, 06 Dec 2010

Where are the Black Box Warnings on These Drugs – I – Mon, 05 Dec 2011

Where are the Black Box Warnings on These Drugs – II – Sun, 11 Dec 2011

Is Amiodarone the Best Drug for Stable Ventricular Tachycardia – Wed, 14 Dec 2011

V Tach Storm – Part I – Wed, 28 Dec 2011

V Tach Storm – Part II – Thu, 29 Dec 2011

Nifekalant versus lidocaine for in-hospital shock-resistant ventricular fibrillation or tachycardia – Wed, 04 Jan 2012

NIH launches trials to evaluate CPR and drugs after sudden cardiac arrest – Sun, 29 Jan 2012

What Will Be the Next Standard Of Care We Eliminate – Wed, 28 Mar 2012

Happy Adenosine Day – Tue, 12 Jun 2012

Too Much Medicine and Evidence-Based Guidelines – Part I – Tue, 26 Jun 2012

Too Much Medicine and Evidence-Based Guidelines – Part II – Tue, 03 Jul 2012

Ondansetron (Zofran) Warning for QT Prolongation – is Amiodarone next? – Part I – Mon, 02 Jul 2012

Ondansetron (Zofran) Warning for QT Prolongation – is Amiodarone next? – Part II – Thu, 05 Jul 2012

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

Wide variability in drug use in out-of-hospital cardiac arrest: A report from the resuscitation outcomes consortium – Part II – Tue, 18 Sep 2012

How do we measure the QT segment when there are prominent U waves? – Thu, 13 Dec 2012

Woman with Risks for Torsades de Pointes Dying within Hours of Leaving the Emergency Department – Wed, 02 Jan 2013

Examples of Ventricular Tachycardia Caused by Amiodarone – Part I – Tue, 28 May 2013

Publication Bias – The Lit Whisperers – Tue, 11 Jun 2013

Standards Of Care – Ventricular Tachycardia – Wed, 31 Jul 2013

–

Footnotes:

–

[1] Dr. Kudenchuk is Misrepresenting ALPS as ‘Significant’
Tue, 12 Apr 2016
Rogue Medic
Article

–

[2] Amiodarone, Lidocaine, or Placebo in Out-of-Hospital Cardiac Arrest
Mon, 04 Apr 2016
Rogue Medic
Article

–

[3] 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. Epub 2016 Apr 4.
PMID: 27043165

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.

–

[4] 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

Free Full Text from European Heart Journal.

–

[5] Amiodarone or procainamide for the termination of sustained stable ventricular tachycardia: an historical multicenter comparison.
Marill KA, deSouza IS, Nishijima DK, Senecal EL, Setnik GS, Stair TO, Ruskin JN, Ellinor PT.
Acad Emerg Med. 2010 Mar;17(3):297-306.
PMID: 20370763 [PubMed – indexed for MEDLINE]

Free Full Text from Academic Emergency Medicine.

–

[6] Amiodarone is poorly effective for the acute termination of ventricular tachycardia.
Marill KA, deSouza IS, Nishijima DK, Stair TO, Setnik GS, Ruskin JN.
Ann Emerg Med. 2006 Mar;47(3):217-24. Epub 2005 Nov 21.
PMID: 16492484 [PubMed – indexed for MEDLINE]

–

[7] Intravenous amiodarone for the pharmacological termination of haemodynamically-tolerated sustained ventricular tachycardia: is bolus dose amiodarone an appropriate first-line treatment?
Tomlinson DR, Cherian P, Betts TR, Bashir Y.
Emerg Med J. 2008 Jan;25(1):15-8.
PMID: 18156531 [PubMed – indexed for MEDLINE]

–

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

–

[9] AMIODARONE HYDROCHLORIDE- amiodarone hydrochloride injection, solution
DailyMed
5 WARNINGS AND PRECAUTIONS
FDA Label

–

[10] Effects of intravenous amiodarone on ventricular refractoriness, intraventricular conduction, and ventricular tachycardia induction.
Kułakowski P, Karczmarewicz S, Karpiński G, Soszyńska M, Ceremuzyński L.
Europace. 2000 Jul;2(3):207-15.
PMID: 11227590 [PubMed – indexed for MEDLINE]

Free Full Text PDF + HTML from Europace

–

[11] Low doses of intravenous epinephrine for refractory sustained monomorphic ventricular tachycardia.
Bonny A, De Sisti A, Márquez MF, Megbemado R, Hidden-Lucet F, Fontaine G.
World J Cardiol. 2012 Oct 26;4(10):296-301. doi: 10.4330/wjc.v4.i10.296.
PMID: 23110246 [PubMed]

Free Full Text from PubMed Central.

–

[12] The calamity of cardioversion of conscious patients.
Kowey PR.
Am J Cardiol. 1988 May 1;61(13):1106-7. No abstract available.
PMID: 3364364

–

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 (2016). Amiodarone, Lidocaine, or Placebo in Out-of-Hospital Cardiac Arrest. The New England journal of medicine, 374 (18), 1711-22 PMID: 27043165

Ortiz M, Martín A, Arribas F, Coll-Vinent B, Del Arco C, Peinado R, Almendral J, & PROCAMIO Study Investigators (2016). Randomized comparison of intravenous procainamide vs. intravenous amiodarone for the acute treatment of tolerated wide QRS tachycardia: the PROCAMIO study. European heart journal PMID: 27354046

Marill KA, deSouza IS, Nishijima DK, Senecal EL, Setnik GS, Stair TO, Ruskin JN, & Ellinor PT (2010). Amiodarone or procainamide for the termination of sustained stable ventricular tachycardia: an historical multicenter comparison. Academic emergency medicine : official journal of the Society for Academic Emergency Medicine, 17 (3), 297-306 PMID: 20370763

Marill KA, deSouza IS, Nishijima DK, Stair TO, Setnik GS, & Ruskin JN (2006). Amiodarone is poorly effective for the acute termination of ventricular tachycardia. Annals of emergency medicine, 47 (3), 217-24 PMID: 16492484

Tomlinson DR, Cherian P, Betts TR, & Bashir Y (2008). Intravenous amiodarone for the pharmacological termination of haemodynamically-tolerated sustained ventricular tachycardia: is bolus dose amiodarone an appropriate first-line treatment? Emergency medicine journal : EMJ, 25 (1), 15-8 PMID: 18156531

Kułakowski P, Karczmarewicz S, Karpiński G, Soszyńska M, & Ceremuzyński L (2000). Effects of intravenous amiodarone on ventricular refractoriness, intraventricular conduction, and ventricular tachycardia induction. Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology, 2 (3), 207-15 PMID: 11227590

Bonny A, De Sisti A, Márquez MF, Megbemado R, Hidden-Lucet F, & Fontaine G (2012). Low doses of intravenous epinephrine for refractory sustained monomorphic ventricular tachycardia. World journal of cardiology, 4 (10), 296-301 PMID: 23110246

Kowey PR (1988). The calamity of cardioversion of conscious patients. The American journal of cardiology, 61 (13), 1106-7 PMID: 3364364

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Filed Under: ACLS, Adenosine, Assessment, Cardioversion, Critical Judgment, Ethics, Ketamine, Pharmacology, Research Blogging, Sedation, Toxicology, V Tach
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