ProCESS trial

[Arcan57]

Discuss.

I for one am getting sick of championing for huge resource intensive initiatives that prove to be no better than standard care 5-10 yrs out.

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[name?]

Discuss.

I for one am getting sick of championing for huge resource intensive initiatives that prove to be no better than standard care 5-10 yrs out.

I hear you. It's funny (and sad) that the most important parts are probably just recognition, abx and fluids, which seem pretty straightforward, especially having trained in the EGDT era.

 

[gman33]

I really don't like it when these resources on used on every patient who just meets certain numbers.
The patient who has terrible functional status at baseline should not get this type of agressive treatment.
That's assumming that it actually works, which may not be the case.

 

[Birdstrike]

Discuss.

I for one am getting sick of championing for huge resource intensive initiatives that prove to be no better than standard care 5-10 yrs out.

Like statins, which to this day, show no proof of preventing heart attack death in otherwise healthy people, and never did? This has been known (and largely ignored) for years. Of course, that didn't stop statins from becoming the # prescribe drug class on THE PLANET.

Good article by David Newman on this,

http://www.epmonthly.com/www.epmont...or-healthy-people-a-cocktail-party-manifesto/

Question everything you are taught.

 

[Arcan57]

The assumption is that physician judgment sucks and needs to be replaced with a checklist to eliminate cognitive errors. The checklist incrementally raises sensitivity while significantly reducing specificity and invariably leads to increased resource utilization.

This focus on the disease causes perceived outcomes to improve because it's now "the system" that is taking credit for the patient's outcome. When a patient does well, it's because the protocol was followed and the hospital can crow over it's processes. When a patient does poorly, it can either be because the patient was unsalvageable or because there was a protocol violation. Due to the massive resources these initiatives take, it's unlikely that it's actually possible to follow the protocol completely. This leads to enormous time and effort being spent in tightening up failure points in the protocol that could be spent questioning whether the protocol is improving outcomes.

This process of focusing resources on discrete diseases is perpetuated by the merit-badge accreditation organizations. The expectation that a hospital's resources will be solely focused on one disease (check out the new Chest Pain or Stroke Center requirements) means those resources aren't available for other diseases. Furthermore, many hospitals look at the infrastructure investment to become certified in one of these processes and realize that the maintenance cost of adding a second certification is relatively minimal. Which of course leads to situations where you now have two or three patient populations that all have the highest priority. This means that the doctor has to prioritize resources in order to provide the most good to the most patients. Which of course we were doing before, it's just that now our decisions create "fall-outs" that have to be explained to an organization full of people who we have never met and who haven't cared for a patient in years. Or else the hospital might lose their merit badge and then people with heart attacks, strokes, or major trauma might stop walking into that ED?

 

[Arcan57]

Like statins, which to this day, show no proof of preventing heart attack death in otherwise healthy people, and never did? This has been known (and largely ignored) for years. Of course, that didn't stop statins from becoming the # prescribe drug class on THE PLANET.

Good article by David Newman on this,

http://www.epmonthly.com/www.epmont...or-healthy-people-a-cocktail-party-manifesto/

Question everything you are taught.

Interesting, I'd never even heard of data linking statins to diabetes.

EDIT: Which I guess shows how little I'm following the primary care literature these days. I still see almost everyone with a lone history of hyperlipidemia on a statin, so I guess I'm not the only one ignorant of the risk/benefit ratio.

 

[NinerNiner999]

Amen, and Amen. Having just spent countless hours in meetings with every major hospital department hammering out an agreed protocol for central line insertion, arguing the nuances of EGDT, and dealing with critical care intensivists who prefer to Monday morning quarterback their departments rather than take leadership of their ICU, I cannot understand the logic of putting every "hot topic" into a protocol, other than putting in writing that the "hospital" has "addressed" the issue. Funny thing is that every other hospital seems to be getting these protocols and "seals of approval" for the same things, taking the competition (market share drives these decisions) out of the equation. All it does is leave behind a huge bill for hospitals to maintain their accreditation because losing it means losing their edge.

Wait a minute - why am I worried? Obamacare is going to fix everything.

 

[Birdstrike]

Wait a minute - why am I worried? Obamacare is going to fix everything.

It already has.

 

[doctorFred]

i went to lunch with Yealy a few years back and we talked about ProCESS; i was genuinely excited. i disliked central lines then, and i dislike them now. i am convinced their marginal benefit is limited to a population that is maybe half of the folks who are currently getting them, maybe even less. especially with everything we know about the inability of CVP to predict fluid responsiveness, the ability to give low dose pressors safely through peripheral lines, and the growing availability of PICC lines for difficult and long-term access.. anyway, i've tipped my hand enough.

 

[Birdstrike]

http://www.nejm.org/doi/full/10.1056/NEJMoa1401602#discussion

"In summary, in our multicenter, randomized trial, in which patients were identified early in the emergency department as having septic shock and received antibiotics and other nonresuscitation aspects of care promptly, we found no significant advantage, with respect to mortality or morbidity, of protocol-based resuscitation over bedside care that was provided according to the treating physician's judgment. We also found no significant benefit of the mandated use of central venous catheterization and central hemodynamic monitoring in all patients."

This result does not surprise me. Doctors have always desperately wanted to feel their super cool gadgets actually make any difference. So the fact that they found no benefit from cool invasive catheters is no surprise to me, anyways. It makes me laugh, actually. Mark my words though, nobody will use them any less. Lol. They'll just come up with other biases to justify using them. It reminds me of the part in House of God where they stop all of there treatments, orders and medications on their floor and the patients suddenly all get better and go home. Lol.

EGDT itself was always a big "duh" event for me. The whole concept was equivalent to saying, "You know, it would really help if you did your job." You mean if someone is septic we're supposed to diagnose it? Yes. (Duh). You mean if we've diagnosed someone with sepsis (meaning "very sick") we're supposed to treat them right away, not in 6 hours or next week? Yes. (Duh). You mean we're supposed to pay close attention to abnormal oxygenation, hematocrit, and perfusion (signs of being "sick") and oxygenate if needed, transfuse if needed and give fluids if needed, sooner rather than later? Yes (duh)

But to think that forming some supposedly simple and dummy-proof protocol and pathway and adding a bunch of gadgets and geeky technical tools and lines are going to improve outcomes for the patients of clinicians who were treating these patients with urgency anyways, and recognized they were sick to begin with, always seemed doomed to fail. On the other hand, is a checkbox protocol policy and a mandate to put in a bunch of invasive lines and focus on central venous numbers make a difference for doctors who couldn't recognize sick patients in the first place, at a hospital that won't staff up ratios to allow nurses to give antibiotics quickly when needed, where people are just slammed through as fast as possible to make room for the next easy-collect quick in-and-out level 3 preferred "customer"?

I think not.

If you do your job, diagnose sick patients, treat your sick patients quickly as you should have been all along, I don't think you need some fancy protocol involving lines and fancy equations.

My point: if you know how to recognize and treat sick patients and you're at a place that carries out your orders promptly, you don't need these protocols that tell you what you should already know and be doing. If you don't recognize sick patients, let them crash while focusing on fast track, you're chronically shorted on nurses to pad the hospital profit margin, maybe you do need these protocols with cute names and can put in a bunch of invasive lines to run up the hospital bill by an order of magnitude. However, such people and places that need such such a "protocol" are exactly those who will not or are not capable of following such a protocol to begin with.

 

[Arcan57]

i went to lunch with Yealy a few years back and we talked about ProCESS; i was genuinely excited. i disliked central lines then, and i dislike them now. i am convinced their marginal benefit is limited to a population that is maybe half of the folks who are currently getting them, maybe even less. especially with everything we know about the inability of CVP to predict fluid responsiveness, the ability to give low dose pressors safely through peripheral lines, and the growing availability of PICC lines for difficult and long-term access.. anyway, i've tipped my hand enough.

I think the main use a CVC has is that it signals to my nurses in a clear and unequivocal way that the patient needs to be resuscitated. I'm half thinking there's some hospital policy I haven't been told about that says that nurses can't infuse more then 1.5L of NS through a peripheral IV. Also, they can't kink off by bending the arm. Since noticing that the patient's bent arm has stopped the flow of IV fluids is a physician level procedure, much like EJs or resuscitative thoracotomies, at my shop sometimes it saves time to throw in a CVC. Also, an ED inserted CVC goes a long way towards prophylaxing against being tossed under the bus by your inpatient colleagues when they don't get around to continuing the resuscitation you started in the ED and the patient goes south. YMMV.

 

[Janders]

I just like that the "code sepsis" we put in place in our community hospital-- (1) get a lactate (2) give a bunch of fluids (3) give a bunch of abx, fast! (4) consider CVL if you are considering pressors (5) Admit to ICU (6) consider trending lactate to assist you in assessing response to therapy-- has all of the benefit of the fancy CVP monitoring, SV02, dobutamine package. Makes me feel good that we pushed for reasonable things (hate to watch a septic patient get 250ml/hr via a 22g PIV) without chasing an ideal that turned out to be ridiculous.

 

[Birdstrike]

I just like that the "code sepsis" we put in place in our community hospital-- (1) get a lactate (2) give a bunch of fluids (3) give a bunch of abx, fast! (4) consider CVL if you are considering pressors (5) Admit to ICU (6) consider trending lactate to assist you in assessing response to therapy-- has all of the benefit of the fancy CVP monitoring, SV02, dobutamine package. Makes me feel good that we pushed for reasonable things (hate to watch a septic patient get 250ml/hr via a 22g PIV) without chasing an ideal that turned out to be ridiculous.

What's the gauge and max flow rate on your CVL? A lot of times a large bore peripheral is larger gauge with a much higher flow rate than some of the central catheters (but, I'm sure you know that). 22g is not adequate for resuscitation. A much larger bore might be. The fact the the line is "central" means nothing alone, from the standpoint of max flow rate. It's all about the catheter size (but, I'm sure you know that). It drives me insane when someone puts in some teeny weeny little angel-hair-noodle central line and they think it's real aggressive because it's "closer to the heart," or because it has multiple lumens, when they don't even know the gauge. Nurses will sometimes reflexively go to a smaller bore in a crisis because they feel they have a higher success rate on placement, but you may be stuck with something so small it has pathetic flow.

I'm going to invent a 5 lumen central line, and it will sell. Why? For the same reason the amazing 7-blade razor sells like hot cakes, at 20 times the price. Because it has......





More.


Yeah....more, of anything. Next year, I'll do the shocking, and unexpected. In a secret reveal, with all media present, I'll debut the 6-lumen catheter to dropped jaws. (Secretly, I will have a 7 lumen in the pipeline for the year after that).

"7 lumens = 7 times better"

(But, "shhh...!") Not any faster for resuscitation.

Absurd? Yes, but demonstrates the absurdity of being wowed by gadgets and the fancy (devices with cool names, bells and whistle, but aren't proven to work any better), over things that are really important, like a couple boring, not so flashy large-bore peripherals that can be placed by anyone, and don't need to be placed by anyone with fancy, super-duper cool skills and lots of fancy letters, titles, and new "protocols."


(8 lumens? Don't you dare even think about it. It can't be done!)

Another example of how we are absolute fools for "the fancy," without demanding any proof of "better":

Da Vinci robot:

http://www.medscape.com/viewarticle/802971

 

[Tiger26]

What's the gauge and max flow rate on your CVL? A lot of times a large bore peripheral is larger gauge with a much higher flow rate than some of the central catheters (but, I'm sure you know that). 22g is not adequate for resuscitation. A much larger bore might be. The fact the the line is "central" means nothing alone, from the standpoint of max flow rate. It's all about the catheter size (but, I'm sure you know that). It drives me insane when someone puts in some teeny weeny little angel-hair-noodle central line and they think it's real aggressive because it's "closer to the heart," or because it has multiple lumens, when they don't even know the gauge. Nurses will sometimes reflexively go to a smaller bore in a crisis because they feel they have a higher success rate on placement, but you may be stuck with something so small it has pathetic flow.

I'm going to invent a 5 lumen central line, and it will sell. Why? For the same reason the amazing 7-blade razor sells like hot cakes, at 20 times the price. Because it has......





More.


Yeah....more, of anything. Next year, I'll do the shocking, and unexpected. In a secret reveal, with all media present, I'll debut the 6-lumen catheter to dropped jaws. (Secretly, I will have a 7 lumen in the pipeline for the year after that).

"7 lumens = 7 times better"

(But, "shhh...!") Not any faster for resuscitation.

Absurd? Yes, but demonstrates the absurdity of being wowed by gadgets and the fancy (devices with cool names, bells and whistle, but aren't proven to work any better), over things that are really important, like a couple boring, not so flashy large-bore peripherals that can be placed by anyone, and don't need to be placed by anyone with fancy, super-duper cool skills and lots of fancy letters, titles, and new "protocols."


(8 lumens? Don't you dare even think about it. It can't be done!)

Another example of how we are absolute fools for "the fancy," without demanding any proof of "better":

Da Vinci robot:

http://www.medscape.com/viewarticle/802971

You'd need the EM equivalent of Roger Federer to endorse you 8-lumen line

 

[medic25]

I'm half thinking there's some hospital policy I haven't been told about that says that nurses can't infuse more then 1.5L of NS through a peripheral IV. Also, they can't kink off by bending the arm. Since noticing that the patient's bent arm has stopped the flow of IV fluids is a physician level procedure, much like EJs or resuscitative thoracotomies,

Most accurate statement I've read in a long time...

 

[Janders]

What's the gauge and max flow rate on your CVL? A lot of times a large bore peripheral is larger gauge with a much higher flow rate than some of the central catheters (but, I'm sure you know that). 22g is not adequate for resuscitation.

Please let me get in on the octo-line. Early goal directed TPN, potassium repletion, triple-action-LR+NS+Albumin resucitation, and Vanco+Zosyn+Clindamycin. ALL AT ONCE!

But seriously, I completely agree with you. To me the potential triggers for a CVL in a septic patient: (1) Just horrible access issues (2) Profound sepsis with suspected "long-term" pressor, or multiple pressor requirement. A pair of 18g PIVs or even an 18g + a 20g can run a LOT of fluid resuscitation, more so than a typical CVL.

My typical move is to get two PIVs in. Give broad Abx, and 3L NS as fast as possible (within first hour... our nurses are good about this). If they are still hypotensive, we keep going with the fluids, but start pressors, usually peripherally. Now we're 4L in, with levophed going in through out best PIV, and we can take a minute and consider CVL placement.

Frankly, its rather rare for me to have a CVL in before they have 4L of NS bolused... typically only if access is a massive issue on arrival, or if they come in truly in profound very fluid resistant shock, and we want to start pressors nearly immediately.

 

[DocEspana]

my goal: create a central catheter that begins at the dorsal vein of the penis. Snake that **** up to a few cm from the right atrium. Make it... idk.... 18G, 20G. Then publish numerous studies showing 'non-inferiority' to other peripheral IVs. It checks off all the necessary marks for quick millions in medical equipment manufacturing.

* Doesn't do any job better BUT DOESNT DO IT WORSE!
* Such an obscure method of insertion that you just know no nurse will do it
* Has that appeal with oncology (cause you know. they care far too much about extrav so they'll appreciate you threading that baby all the way to the heart)
* Catchy name (trying to decide if its more like a Cordis, so call it the Peendis, or if its like a PICC, so we can call it a PISS)
* No competition among other "dorsal vein access devices" means its a market waiting to be monopolized.

 

[Birdstrike]

my goal: create a central catheter that begins at the dorsal vein of the penis. Snake that **** up to a few cm from the right atrium. Make it... idk.... 18G, 20G. Then publish numerous studies showing 'non-inferiority' to other peripheral IVs. It checks off all the necessary marks for quick millions in medical equipment manufacturing.

* Doesn't do any job better BUT DOESNT DO IT WORSE!
* Such an obscure method of insertion that you just know no nurse will do it
* Has that appeal with oncology (cause you know. they care far too much about extrav so they'll appreciate you threading that baby all the way to the heart)
* Catchy name (trying to decide if its more like a Cordis, so call it the Peendis, or if its like a PICC, so we can call it a PISS)
* No competition among other "dorsal vein access devices" means its a market waiting to be monopolized.

Just make sure you include some meaningless marketing terms in the name, and it will sell. Like "smart," ie, "Smart-catheter" (like smart-phone,) "evidence based," "clinically proven," or "organic," "gluten-free," "BPA-free," "cloud-based," or "premium." Or call it "Peendis-GT 3," implying it's way better than some previous versions that actually never existed (wait, was there ever a non-GT version? Or GT1, GT 2?).

Marketing goes a long way, in business and especially in medicine.

 

[BoardingDoc]

http://xkcd.com/641/

 

[ORL10]

I don't see why its surprising that CVC don't improve mortality. They are not a therapeutic intervention, and in order to improve mortality they must be coupled to an intervention that does. Since no novel interventions for sepsis have shown a mortality benefit (sorry xigris) in the last 10 years.

Does this mean the CVC is dead? No. The access makes lab draws and infusion of centrally acting pressors and multiple medications in the ICU feasible and less logistically challenging. Remember the study was completed for 6 hours, and ICU care thereafter was dictated by intensivists who likely placed a CVC or had a PICC put in. Please don't send hypotensive patients to the ICU with 22g in the finger, or a DP 20g as your only IV for abx, resuscitation, insulin drips, sedation, vasopressors etc...you see my point

I generally agree that in the ED it is early recognition, early abx, judicious fluids with reassessment of volume probably makes the most difference and that prbc tx, dobutamine, scvo2 monitoring and CVP goals are unlikely to be helpful.

In the unit probably avoiding over sedation (I'm in the no benzo camp), prevention and/or active treatment of delirium, low tidal volumes, and early PT/OT gives you the biggest bang for your buck.

 

[Bostonredsox]

Similar thread going in CC forum if mods want to combine them. Would be great to get the Ed input and the MICU input in the same thread.

 

[Libertas]

Commenting on several of the above posts....serious question (not trying to troll, promise)... I know there have been several threads where EM has discussed how they are the resuscitation experts. Why do EM physicians spend so little time getting deft at peripheral line insertions? Countless times in my lvl1 ED do I see ER nurses/techs infiltrating the proximal veins when there were nice big veins distally, where nobody even tried to look or insert an IV. 16/14g peripherals are faster and safer to insert than a central line, and a short 14g has better flow rate than an 8.5f.

Not to mention another pet peeve...where even if the nurse puts in a 'large' PIV, they put one of those tiny extensions on it that effectively turns it into a 22g. Ugh.

 

[Arcan57]

Because we have nurses that are very skilled at putting in big IVs in little veins on dehydrated/shocky patients and we're dealing with multiple patients at one time. If we were anesthesiologists who had one patient at a time to deal with and +/- nurses that are decent at IVs, it makes sense to become scary good at peripheral IVs. Our best nurses put in ~10 IVs/shift on all comers and it's unlikely I would ever catch up to them in terms of experience. If someone truly needs volume STAT I can whip in a Cordis or make all 4 limbs sprout IOs if my nurses can't get 14s in. That situation is really rare (at least at my shop) and many shops have rules restricting the use of 14 or 16g due to fears of it being used as a punitive measure. As far as the extension tubing, it clearly is more convenient for the nurses than attaching the line straight to a hub so it typically takes reminding the nurse of its flow restriction since they do it by rote.

 

[scummie]

Not sure if this has been mentioned, but there is a new podcast from EmCrit about the trial. Haven't listened to it yet, but should add some perspective.

http://emcrit.org/podcasts/process-trial/

 

[EvoDevo]

Not sure if this has been mentioned, but there is a new podcast from EmCrit about the trial. Haven't listened to it yet, but should add some perspective.

http://emcrit.org/podcasts/process-trial/

It's a really good episode. Very informative and breaks down the trial well with the PI

 

[UnderwaterDoc]

my goal: create a central catheter that begins at the dorsal vein of the penis. Snake that **** up to a few cm from the right atrium. Make it... idk.... 18G, 20G. Then publish numerous studies showing 'non-inferiority' to other peripheral IVs. It checks off all the necessary marks for quick millions in medical equipment manufacturing.

* Doesn't do any job better BUT DOESNT DO IT WORSE!
* Such an obscure method of insertion that you just know no nurse will do it
* Has that appeal with oncology (cause you know. they care far too much about extrav so they'll appreciate you threading that baby all the way to the heart)
* Catchy name (trying to decide if its more like a Cordis, so call it the Peendis, or if its like a PICC, so we can call it a PISS)
* No competition among other "dorsal vein access devices" means its a market waiting to be monopolized.

I LOL'd.

Better yet, call it the Dorsal Peendis (Patent Pending).

 

[Daiphon]

I LOL'd.

Better yet, call it the Dorsal Peendis (Patent Pending).

Nah...

D orsal
I ntravenous
C atheter (not for)
K ids

I like this better. ;-)
-d