If you have a BVM (Bag Valve Mask resuscitator), you should not need naloxone. The problem is inadequate respiration, not inadequate naloxonation.

- Rogue Medic

Dr. Ken Grauer on Killing Patients Just to Get a Temporary Pulse With Epinephrine – Part I

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Dr. Grauer,

I love your ACLS 2nd edition and learned more about ACLS from your book than from any other source. You and Daniel Cavallaro did a great job of presenting the material in a way that encourages thinking and assessment. I think that your presentation of the rationale behind the possible treatments ahead of the 1992 ACLS was a great service to those who were able to read your book. I used it long after your third edition came out, because of the way you analyzed the treatments.

-

Dr. Grauer wrote a lot in two comments, in response to Killing Patients Just to Get a Temporary Pulse With Epinephrine, with only the abstract as a reference for the first comment. I will try to address a point, or two, at a time without distorting his meaning.

-

Observational studies are just that – observations – NOT proof. Based on observational studies done on large numbers of women we routinely treated with estrogen for many years – until controlled, prospective trials were done and showed the fallacy of that previously uniformly accepted observational dogma …

This is the primary difference in our views of the research.

I am not stating that we should use observational data to add an unexamined treatment.

No, I want much better evidence that any treatment works. It would not be good patient care to treat patients based only on observational data, but what we have to support the use of epinephrine in cardiac arrest epinephrine is not even as good as observational data.

An observational study showing a benefit from the use of epinephrine would be a tremendous contribution to the research supporting epinephrine in cardiac arrest, because there is no outcomes research supporting epinephrine in cardiac arrest. Nothing.

We have several studies showing harm from epinephrine, but no studies showing any benefit. 50 years of absolute failure to produce a single study showing improved outcomes with epinephrine. What is wrong with us?

-

We are treating patients based only on surrogate endpoints. Improved circulation in the laboratory and improved ROSC (Return Of Spontaneous Circulation).

Surrogate endpoints are only useful for generating hypotheses about possible outcomes studies. Surrogate endpoint studies are much lower quality than observational studies.

When surrogate endpoints are examined, they consistently fail to demonstrate improvement in outcomes.

We are not helping our patients if we do not pay attention to any studies that consistently show harm.

First, do no harm, is supposed to be an important consideration. No harm is impossible,[1] but we should minimize the potential harm.

After 50 years, where is any evidence of improved survival from epinephrine?

 

How useless is a drug, that after 50 years of use we cannot show ANY benefit?

 

The goal is not to produce a temporary pulse. The goal is to produce survivors.

 

Where are the survivors?

 

With epinephrine, 2,786 patients had ROSC.

Only 805 patients were alive one month later.

Why do almost all of the patients who get epinephrine die very quickly?

Only 205 patients had good brain function.

Why do almost all of the patients not killed by epinephrine end up with severe brain damage?

93% of the ROSC patients were dead or disabled with epinephrine.

More ROSC, but they don’t survive. All of the research has the same result.

If this is not the typical epinephrine response, then somebody needs to prove it.

We need to stop killing patients with epinephrine.

50 years of trust us, it works, means 50 years of killing patients just to get a quick pulse that often does not even last until the emergency department.

-

Footnotes:

-

[1] A piece of my mind: the harm of “first, do no harm”.
Shelton JD.
JAMA. 2000 Dec 6;284(21):2687-8. No abstract available.
PMID: 11105155 [PubMed - indexed for MEDLINE]

Much of the rest of the world operates on sensible risk/benefit principles and by embracing error. But medicine tries to operate on impossible zero-tolerance principles and by denying error. Paradoxically, the old concept leads to too much harm.

.

Killing Patients Just to Get a Temporary Pulse With Epinephrine

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Today in JAMA there is a non-randomized observational study of epinephrine vs. no medicine in 417,188 EMS cardiac arrest patients. I will be writing about this study in more detail, but I have already written a lot about the earlier studies that demonstrate the harm of epinephrine in cardiac arrest.

We never had a good reason to make epinephrine the standard of care in cardiac arrest.

 

Never.

 

The goal of resuscitation is NOT to get a pulse back.

But . . . but . . . but . . . if we don’t get pulses back, we can’t resuscitate patients.

Yes, but that does not mean that it does not matter how much harm we do in order to get pulses back.

Just because epinephrine increases the rate of return of pulses does not mean that epinephrine increases the rate of survival to discharge.

In the treatment of cardiac arrest, nothing is more important than survival to discharge.

OK, survival to one month is more important. Survival to one year is more important. Survival to ten years is more important.

A pulse for a few days is not important. A pulse for a few hours is not important. A pulse for a few minutes is not important. There is a word to describe these patients who never leave the hospital – dead.

-

only 1.4% of patients in the epinephrine group had good neurological outcomes, despite a 5.4% survivalrate (Table 1). Thus, only about 25% of survivors had good neurological outcomes.[1]

Thus, properly evaluating this traditional therapy now seems necessary and timely and should consist of a rigorously conducted and adequately powered clinical trial comparing epinephrine with placebo during cardiac arrest. Such a trial has previously seemed unethical, and investigators who have attempted to perform this comparison have received unwarranted criticism in their communities.17,19 [2]

The only thing unethical has been the resistance from those defending the Standard Of Care, that was nothing more than a refusal to examine tradition.

While awaiting results of such a definitive trial, physicians and other practitioners involved in cardiac resuscitation must consider carefully whether continued use of epinephrine is justified.[2]

How can we justify a treatment that has never been based on any study of survival? We do not have any good reason to expect that the results of a randomized placebo-controlled study will support continuing use of epinephrine.

Epinephrine should only be used in cardiac arrest as a part of controlled studies.

-

Expert recommendations must come with an expiration date.

 

No exceptions.

 

If the expert recommendation is not followed by appropriate research, then the expert recommendation should not be treated better than the patients.

-

ROSC (Return Of Spontaneous Circulation) is nice, but ROSC is only a surrogate endpoint. If we are creating a dangerous condition by transporting the patient to the hospital; if the patient never wakes up; if we create false hope for the family; if we generate huge bills that may bankrupt the family; if we takes hospital staff away from the treatment of other patients – where is the benefit?

But . . . but . . . but . . . the family will be able to say goodbye to their loved one while the person has a pulse.

Really?

How many millions of dollars is that worth to make us feel good, regardless of what the family wants?

Why do we assume that this is what the family wants? Do we ask? Of course not – we don’t want to risk learning the truth.

-








 

50 years of tradition, unimpeded by progress.

 

Forget it, Jake. It’s Chinatown.

 

There is also audio of an interview with Dr. Calloway, who wrote the accompanying editorial.[3]

Thank you to William Toon, PhD. of the EMS EduCast for bringing this to my attention.

-

Footnotes:

-

[1] Prehospital Epinephrine Use and Survival Among Patients With Out-of-Hospital Cardiac Arrest
Akihito Hagihara, Manabu Hasegawa, Takeru Abe, Takashi Nagata, Yoshifumi Wakata, Shogo Miyazaki
JAMA. 2012;307(11):1161-1168.
doi:10.1001/jama.2012.294

Free Full Text in PDF format

-

[2] Questioning the Use of Epinephrine to Treat Cardiac Arrest
Clifton W. Callaway
JAMA. 2012;307(11):1198-1200.
doi:10.1001/jama.2012.313

-

[3] Questioning the Use of Epinephrine to Treat Cardiac Arrest
Clifton W. Callaway
JAMA: March 21, 2012; Vol 307, No. 11,
Author Interview
podcast in mp3 format (06:29, 3.7 MB)

-

.

Is It Possible To Be Alert And Oriented With 10/10 Pain – Part II

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Continuing from Part I. Unfortunately, with my protocols, an altered level of consciousness prohibits me from giving opioid pain medication on standing orders for burns or for musculoskeletal trauma.

-

-

d. Patient has altered level of consciousness [1]

Isn’t the problem the severity of the pain?

If I have pain that is truly 10 out of 10, is it possible for me to NOT have an altered level of consciousness?

For example, if I were using a wood chipper and had an arm dragged into the blades before I could hit the safety bar (the orange rail around the opening), I would not expect to be able to provide reasonable answers to any of the level of consciousness questions we routinely ask.

-


Image credit.

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What is my name?

Maybe I can get that one right.

Where am I?

I’m stuck in a chipper. There might be some superfluous adjectives included in my response, but is that question really appropriate at this time?

Do I know what day it is today?

Could today be the day I engage in a bit of justifiable homicide? I ordinarily look at my cell phone to find out the date. My hand appears to be occupied, so I may not have easy access to my phone – assuming that I even want to answer the question.

We do want to know about allergies and medical conditions, but the only reason to ask level of consciousness questions is a misguided effort to treat the protocol at the expense of the patient.

Are there any signs of a head injury? That would be much more useful information than Alert and Oriented Times Three.

The truth of severe pain is that level of consciousness improves AFTER several doses of pain medicine.

We should expect level of consciousness and vital signs to improve after treatment with high doses of medications that would be expected to worsen level of consciousness and vital signs in people who do not have severe pain.

Pain medicine can be morphine, fentanyl, hydromorphone (Dilaudid, Palladone), or other opioid medication. Another possibility to help in extricating me from the wood chipper, that is less likely to produce respiratory depression, is ketamine.

-

Imagine that extreme amount of pain, the pain continuing at about the same level, then having to reverse the wood chipper to get my arm out.

Do you imagine that there would be a normal level of consciousness on my part?

Is that an acceptable reason to deny me treatment?

Is that an acceptable reason to deny me treatment that will probably improve my level of consciousness?

Suppose that I had severe burns, rather than musculoskeletal trauma. Would the concern about level of consciousness be any different?

-

-

What do you think?

-

Footnotes:

-

[1] Musculoskeletal Trauma 6003 and Burns 6071
Pennsylvania Statewide Advanced Life Support Protocols
7007 – ALS – Adult/Peds
Page 73/128 and Page 80/128
Free Full Text PDF of All ALS Protocols

.

Comment on Immobilization or not that is the question – EMS Garage Episode 156

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In response to Immobilization or not that is the question – EMS Garage Episode 156, is this comment from mpatk

“Where is ANY research to contradict this study?”

There is nothing to contradict. This study says NOTHING about the effect of pre-hospital immobilization. Absent the comparison of pt condition on-scene vs. hospital arrival vs. discharge, all it tells us is that people in Malaysia were 1/2 as likely to have spinal damage from traumatic accidents.

Even if this study had not been done, there would definitely be something to contradict. The null hypothesis.

 

The default conclusion is always that the treatment is NOT beneficial – for every treatment, until clearly demonstrated otherwise.

 

When studied, almost every treatment has failed to demonstrate any benefit.

Many treatments are great as ideas, but horrible in practice.

-

“This study is much better than all of the studies that do not exist.”

Something is not always better than nothing. Your quote by Niels Bohr about understanding true and false things applies here. This study is IMHO misleading and not merely flawed.

Misleading?

The study is only misleading if it leads to false conclusions. We would need to have evidence of benefit and evidence of safety to be able to claim that this study is misleading.

Someone needs to demonstrate that the results of this study are incorrect for it to be misleading. Where is there any evidence that this study leads to incorrect conclusions?

-

As for the lack of studies and who is responsible? IMHO that’s politics, public opinion, and liability resulting in bad science.

In this case, the result is science with limitations.

-

If removing a “standard of care” for an experiment resulted in statistically significant increase in permanent neuro deficits, the result would be the injured parties crying havok and letting slip the ambulance chasers of liability;

Why is it acceptable for any lawyer to practice medicine without a medical license?

Where is any evidence that applying rigid collars and strapping people onto backboards provides any benefit?

We can always make excuses for doing the wrong things to patients.

In the absence of evidence of benefit, it is foolish to assume that there is any benefit

-

God forbid there was any question of informed consent with any of the bad outcome patients. The attitude of the Powers That Be will always be a twist on the title of the older podcast (which I’m still trying to find on iTunes): “If even one person is harmed by not immobilizing the spine…” :-/

The Powers That Be are just the embodiment of the fear of doing the right thing.

I’d love to get definitive evidence one way or another; I doubt most medics are sadistic enough to want to immobilize patients on a hard board unless necessary. I think unfortunately that we’d need to have a first study to show that the immobilization is done correctly (i.e. proper padding of voids, proper movement onto the board, etc…) before you can convince anyone to study whether the technique itself is valid.

How do we know what the correct way is?

Many of us have become careless in EMS, at least compared to what we were taught in school, but that does not mean that what we were taught in school was the correct way to immobilize

We need to study what we do by initially looking at the effect on surrogate endpoints, then study anything that appears to improve the surrogate endpoints to find out if it improves the outcomes that matter. If surrogate endpoints mattered, we would not call them surrogates.

Just because dumping fluids into patients with uncontrolled bleeding may raise their blood pressures sometimes does not mean that it improves survival. We no longer dump fluids into these patients, except in the most backward systems.

Just because furosemide (Lasix) to patients with acute CHF (Congestive Heart Failure) may fill their bladders sometimes does not mean that it improves survival. We no longer give furosemide to these patients, except in the most backward systems.

Just because bleeding patients with almost any complaint may relieve that complaint sometimes does not mean that it improves survival. We no longer bleed these patients, except in the most backward systems.

-


Image credit.

.

Immobilization or not that is the question – EMS Garage Episode 156

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Chris Montera, Scott Keir, Dr. Dave Ross, Sam Bradley, Patrick Lickiss, and I discuss the lack of evidence of any benefit from spinal immobilization.

Immobilization or not that is the question: EMS Garage Episode 156

 

Any standard of care that does not have evidence of benefit needs to have an expiration date.

 

What do we do that causes the most stress on an unstable spinal fracture?

Placing a cervical collar on the neck and strapping the patient to a board increases the stress on any unstable spinal injury.

-

Why do we let a superstition become the Standard Of Care?

Because we can’t tell the difference between superstition and medicine.

-

-

There is no evidence that spinal immobilization ever provided any benefit to anyone.

There is evidence that spinal immobilization doubles the rate of disability among people with spinal injuries – exactly the people it is supposed to protect.[1]

Spinal clearance protocols do cut down on the pain and suffering of those without spinal injuries.

Spinal clearance protocols make it more likely that the people with spinal injuries will be endangered by manipulating their spines into rigid EMS collars and onto rigid boards.

Making the patient fit the board, rather than making the board fit the patient, is not good medicine. It does not even make sense.

Without evidence of safety, spinal immobilization should be stopped.

Without evidence of benefit, spinal immobilization should be stopped.

-

Go listen to the podcast.

Also listen to – A Change of the Dogma – If spinal immobilization helps only one . . .

-

Footnotes:

-

[1] Out-of-hospital spinal immobilization: its effect on neurologic injury.
Hauswald M, Ong G, Tandberg D, Omar Z.
Acad Emerg Med. 1998 Mar;5(3):214-9.
PMID: 9523928 [PubMed - indexed for MEDLINE]

.

Is It Possible To Be Alert And Oriented With 10/10 Pain – Part I

-

Unfortunately, with my protocols, an altered level of consciousness prohibits me from giving opioid pain medication on standing orders for burns or for musculoskeletal trauma.

-

-

I can call command for permission to treat the patient, just as I can call for permission to treat abdominal pain or other exclusions from my standing orders. My patient does have to wait for me to go through the Mother May I? ceremony of ignorance. This requirement encourages medical directors to authorize incompetent paramedics and distracts paramedics from patient assessment, but it appeals to the insecurities of the hands-off medical directors.

As if appropriately treating pain aggressively is dangerous.

-


Image credit.

-

What do you think?

If this is your arm, is pain medicine a bad idea?

Let’s look at the exclusions –

a. Oxygen saturation ≤ 95% [1]

Give supplemental oxygen and give the pain medicine. Unfortunately, waiting for the sat to rise may cause the patient more pain. We should be raising the patient’s sat to 95% anyway, but the low sat may help to decrease alertness and awareness of pain a little bit.

Is hypoxia really a problem when giving fentanyl?

Assessment of the 522 administrations in 279 non-intubated patients revealed no difference in the mean SpO 2 readings before (98.8%, 95% CI 98.5–98.9) and after (98.6%, 95% CI 98.3–99.0) fentanyl administration. There were no instances of hypoxemia in these non-intubated patients receiving fentanyl (one-sided 97.5% CI for 0/279: 0–1.3%). [2]

No cases of hypoxia caused by fentanyl, even though these patients were given large doses. The average total dose was 3.0 μ/kg.

3.0 μ/kg is the maximum total dose available on standing orders in my protocols, but 3.0 μ/kg was just the average total dose for these patients who never experienced any hypoxia.

-

b. SBP < 100 for adults

c. SBP < 70 + 2(age in years) for children < 14 y/o [1]

Is hypotension really a problem when giving morphine?

Sometimes.

Is hypotension really a problem when giving fentanyl?

of 2129 patients receiving an opioid (fentanyl), only 12 (0.6%) had a medication-related vital sign abnormality and an intervention was required only once (in a patient who had no sequelae)(8) [3]

Overall, in 45 cases (4.3% of 1055), fentanyl was administered to patients who were hypotensive. [2]

Oh, no!

They’re all going to die!

In 53% of these cases, hypotension (predictably) remained after the opioid was given—but in 47% of cases in which fentanyl was administered to hypotensive patients, the next SBP exceeded 90. [2]

Inconceivable!

Is hypotension really a problem when giving fentanyl?

No.

There is no good reason to avoid giving fentanyl for severe pain with hypotension.

 

The best thing to do for hypotension may be to give fentanyl.

 

-

d. Patient has altered level of consciousness [1]

This will be the topic in Part II.

-

Footnotes:

-

[1] Musculoskeletal Trauma 6003 and Burns 6071
Pennsylvania Statewide Advanced Life Support Protocols
7007 – ALS – Adult/Peds
Page 73/128 and Page 80/128
Free Full Text PDF of All ALS Protocols

For people working in EMS in Pennsylvania, there is a FREE app that includes BLS protocols and ALS protocols from the University of Pittsburgh Medical Center. Rather than have to go through all of the protocols to find the right one, this allows for very quick searching of individual protocols and for the use of other features. I have found this to be very handy for checking the specifics of a protocol I have not looked at in a while. Please, let me know if there are other similar apps out there.
FREE Android app page.
FREE iPhone app page.

-

[2] Fentanyl in the out-of-hospital setting: variables associated with hypotension and hypoxemia.
Krauss WC, Shah S, Shah S, Thomas SH.
J Emerg Med. 2011 Feb;40(2):182-7. Epub 2009 Mar 27.
PMID: 19327928 [PubMed - in process]

Full Text PDF Download at medicalscg.

-

[3] Safety and effectiveness of fentanyl administration for prehospital pain management.
Kanowitz A, Dunn TM, Kanowitz EM, Dunn WW, Vanbuskirk K.
Prehosp Emerg Care. 2006 Jan-Mar;10(1):1-7.
PMID: 16418084 [PubMed - indexed for MEDLINE]

Free Full Text PDF Download from MSTC.

.

Gathering of Eagles 2012 Preview

-

Fossil Medic posted the schedule for tomorrow’s Gathering of Eagles conference.

I wish I could be there, but it is not in my budget.

What are the most interesting topics?

The Results Are In: The Outcomes of Recent Outcome Studies!

A block of 10 minute summaries of these recent outcomes studies. Unfortunately, I do not think that 10 minutes is appropriate coverage for these, because they have some important, but subtle points that probably cannot be adequately covered in 10 minutes.

-

9:00am-9:10am Epileptic Fix: Hot-Off-the-Press Results from the RAMPART Trial
Jason T. McMullan, MD (Cincinnati)

I have already written a few posts about this.[1]

My 30 second coverage –

This is a well done study that confirms what we should already have been doing. IM (IntraMuscular) midazolam (Versed) works significantly faster and significantly more often than IV (IntraVenous) benzodiazepines (lorazepam [Ativan] in this case).

There was no good reason to avoid using IM midazolam as the initial treatment before this study.

There is much less reason to avoid using IM midazolam as the initial treatment after this study.

-

9:15am-9:25am To ITD or Not To ITD: Reconciling the ROC and ResQ Trial Results
R. J. Frascone, MD (St. Paul)

Dr. Keith Wesley should have a lot to say about this.

I wonder about the wisdom of stopping any trial early because of the appearance no difference in outcomes.

In what way is that a good idea?

A study is supposed to generate the information we need to make decisions about future treatment. If there is no apparent difference, almost no reason to stop the trial early. Most of the money is already spent. There is no increased protection to patients. The people who think the intervention was a good idea will not be satisfied that it has been convincingly shown to be useless. Subgroup analyses that might lead to hypotheses for future studies may not be possible with smaller numbers.

Stopping this early was just a bad idea. Like a kid who does not see immediate results and decides he won’t play any more.

-

9:30am-9:40am CIRCular Arguments: Was It Win, Lose or Draw in the CIRC
Auto-Pulse Trial ?
David E. Persse, MD (Houston)

CIRC (Circulation Improving Resuscitation Care) will probably continue to produce more excuses than benefits.

The problem is the poor quality of human CPR.

The answer is not to get a machine to perform the CPR.

The answer is to improve our understanding of CPR. We do not think about what we are doing when we are compressing the chest. All other parts of CPR are a waste, so our misunderstanding encourages us to ventilate and transport.

Ventilation has not been demonstrated to improve outcomes.

Transportation has not been demonstrated to improve outcomes.

CPR machines have not been demonstrated to improve outcomes.

We have just been making excuses for bad education, bad oversight, and bad outcomes. The AutoPulse does not improve any of these.

-

9:45am-9:55am A Very Cool Way to Save Lives: Intra-Arrest Therapeutic Hypothermia
John P. Freese, MD (New York)

An interesting idea.

Is this a way to decrease the damage done by epinephrine?

Is this something that does improve outcomes?

-

10:10 am-10:30am The Eagles Wing It: Lightning Rounds # 1
with above speakers and several others…
U.S. Metropolitan Municipalities EMS &
Federal Agency Medical Directors

This should be very interesting. Fortunately, it is 20 minutes, rather than just 10 minutes.

-

And a topic I write about a lot –

2:40pm-3:00pm Do You Have the Backbone for this Debate?
Is Spinal Immobilization Really Good for You?
Neal J. Richmond, MD (Louisville) vs.
Jonathan Jui, MD, MPH (Portland)

The question is easy to answer.

 

We have no evidence to support the current use of spinal immobilization.

 

None.

-


Image credit from Voodoo Medicine Man.

-

-

We have evidence of pain, increased neck and back pain, decubiti, and airway compromise.

There is evidence of significantly increased disability with spinal immobilization.

We all want to decrease the rate of disability among people with unstable spinal fractures. There is no reason to assume that the current method of spinal immobilization does what its advocates claim it does – protect patients from worsening injury. There is evidence that it does exactly the opposite.

Out-of-hospital spinal immobilization: its effect on neurologic injury.
Hauswald M, Ong G, Tandberg D, Omar Z.
Acad Emerg Med. 1998 Mar;5(3):214-9.
PMID: 9523928 [PubMed - indexed for MEDLINE]

There is a lot more we should know about spinal immobilization, but this is the best available evidence.

Any advocate of spinal immobilization MUST come up with better evidence to justify continuing this demonstrably harmful practice.

Anything else is unethical.

-

Footnotes:

-

[1] Intramuscular Midazolam for Seizures
Rogue Medic

Part I

Part II

Part III

Part IV

.

Psychic vs. RAD-57

Also posted over at Paramedicine 101 (now at EMS Blogs).

-

Continuing what I wrote Tuesday and Wednesday about the repeated failure of Masimo’s RAD-57 to correctly discriminate between CO (Carbon monOxide) poisoning and no exposure to CO.[1], [2]

Given the whimsical nature lack of reliability of the RAD-57, should this be an example of what ambulances will look like?

Maybe I should ask a psychic.

-


Image credits – 1, 2, and 3.

-

There are two big advantages that the RAD-57 has over the psychic.

1. Many cases of CO poisoning are probably not diagnosed due to vague symptoms that go away when the person leaves the environment.

2. Sometimes the RAD-57 does seem to get it right, but only sometimes.

-

There is one big disadvantage of the RAD-57 compared to the psychic.

Nobody is going to send a firefighter back to fight a fire based on the word of a psychic – at least I hope not.

Firefighters are probably being screened to safety with the RAD-57.

How many hospitalized firefighters, or dead firefighters, will it take to demonstrate that the RAD-57 is not accurate enough to use to screen for CO poisoning?

-

MK, from Probie To Practitioner, writes –

We have the RAD-57, and I would agree that it’s a fairly unreliable device. I once put it on my finger to try it out on the way to a call, and it gave me a reading of 7%. I have never smoked a day in my life, and before getting on the ambulance, I had spent almost 4 hours doing station chores outside.[3]

This is above the 6.6% cut-off for CO poisoning recommended in the most recent study.[4]

Maybe MK did not use the RAD-57 correctly.

-

Quick and easy-to-use—requires no user calibration and does not require patient cooperation or consciousness.[5]

While Masimo is not exactly stating that the RAD-57 is So easy a caveman could use it, ease of use and simplicity are emphasized in their sales pitch.

Claims of operator error demonstrate dishonesty on the part of Masimo.

Is the RAD-57 easy to use, or do we have to align it with the patient’s chi forces, when the moon is just right, after doing a voodoo dance?

The Masimo slogan appears to be –

Trust Masimo. It’s always operator error, never equipment failure.

-

-

Too Old To Work, from Too Old To Work, Too Young To Retire, writes –

Funny you should bring this up. A few months ago we were sent to a “possible CO leak” with mulitple patients. The only problem was the the FD got readins of 0 when they tested the air for CO. Which was confusing to say the least because the first unit on scene with a RAD 57 got a reading of 18 ppm on an elderly gentleman who had some dypnea and chest pain.

The supervisor was convinced that the FD didn’t know what they were doing because of the RAD 57 readings.

Too Old To Work goes on to provide more details in the rest of his comment.[6]

The problem identified in the Touger study was that the RAD-57 was not sensitive enough. The Rad-57 missed most of the actual cases of CO poisoning.[7] The solution seems to be to increase the sensitivity to the point where saying, Carbon monoxide, will set it off.

The question still unanswered is –

 

How many cases of CO poisoning does the RAD-57 miss?

 

We will probably only learn this from the lawyers, because Masimo has not been providing useful information.

-

Footnotes:

-

[1] Accuracy of Noninvasive Multiwave Pulse Oximetry Compared With Carboxyhemoglobin From Blood Gas Analysis in Unselected Emergency Department Patients
Rogue Medic
Tue, 21 Feb 2012
Article

-

[2] Mass sociogenic illness initially reported as carbon monoxide poisoning.
Rogue Medic
Wed, 22 Feb 2012
Article

-

[3] Mass sociogenic illness initially reported as carbon monoxide poisoning.
Paramedicine 101
02/22/2012 at 13:44

Comment by MK

-

[4] Accuracy of noninvasive multiwave pulse oximetry compared with carboxyhemoglobin from blood gas analysis in unselected emergency department patients.
Roth D, Herkner H, Schreiber W, Hubmann N, Gamper G, Laggner AN, Havel C.
Ann Emerg Med. 2011 Jul;58(1):74-9. Epub 2011 Apr 2.
PMID: 21459480 [PubMed - indexed for MEDLINE]

Annals of Emergency Medicine podcast
Podcast Download in MP3 Format

Because a false-negative reading could have serious medical consequences, this device should be tested in a much larger number of poisoned patients to confirm the generalizability of our stated cutoff values.

-

[5] RAD-57
Masimo
Product information page

-

[6] Mass sociogenic illness initially reported as carbon monoxide poisoning.
Paramedicine 101
02/23/2012 at 03:00
Comment by Too Old To Work

-

[7] Performance of the RAD-57 pulse CO-oximeter compared with standard laboratory carboxyhemoglobin measurement.
Touger M, Birnbaum A, Wang J, Chou K, Pearson D, Bijur P.
Ann Emerg Med. 2010 Oct;56(4):382-8. Epub 2010 Jun 3.
PMID: 20605259 [PubMed - indexed for MEDLINE]

Free Full Text Article from Ann Emerg Med with links to Free Full Text PDF Download

The RAD device correctly identified 11 of 23 patients with laboratory values greater than or equal to 15% carboxyhemoglobin (sensitivity 48%; 95% CI 27% to 69%).

Less than half?

.