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A low-cost ventilator based on the Ambu Bag (do you think a “Gold Standard” Placebo control is needed . . . )

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Ventilators are a key treatment for Covid-19, and there has been a wave of interest concerning development of low-cost ventilators; especially with a projected Covid-19 wave in excess of 100 millions for Africa. Here, then, is the Israel developed AmboVent, one of something like 300 fast-track initiatives to develop such globally:

Video:

This is of course one of several designs pivoting on the nearly ubiquitous manual respirator bulb, as per a suggestion that has been on the table for some time. Now we see a [near-?] commercial product. Video on the suggestion:

Their blurb:

The AmboVent initiative is led, by the Israeli Air Force (IAF) 108 electronic depot in partnership with Magen David Adom (MDA) (Israel’s red cross). The R&D phase was backed by a large community of innovators, to include: makers from First Robotics Israel (mentors and students), physicians from leading Israeli hospitals such as Tel Aviv Sourasky and Hadassah JLM as well as other medical centers, Engineers from Haifa Technological Center and The garage program by Microsoft Israel, IAF Unit 108, and more. All have joined the endeavor on a voluntary basis. This Ad hoc team work together as an open organization aiming at providing in an ultra-short time a viable, usable, simple and intuitive to use mechanical ventilator.

This is obviously globally deployable and could readily be set up in even an Ambulance. As a news article suggests:

“This can ventilate millions in Africa when no other machine is around,” Eliram was quoted by the Times of Israel as saying. “In Africa, they haven’t fully woken up to the coronavirus and there are hardly any ventilators, so this can make a huge difference.”

World Health Organization statistics show that there are only 2,000 ventilators in the whole of Africa – less than the amount in Israel. Some African countries don’t have any. A report by the UN Economic Commission for Africa said the continent, which is a few weeks behind Europe in regards to the spread of the pandemic, will likely be dealing with 122 million infections.

AmboVent is also producing 20 prototypes to send to other countries on a limited budget of $200,000. The team is also launching a crowdfunding campaign.

“The situation with ventilators is dire,” Eliram said. “Even with some of the ventilators you can get, you can’t get the valves anymore, so people are calling and saying we want this machine that isn’t dependent on sourcing supplies after it is made.”

AmboVent uses a robotic arm to operate a bag-valve mask, like the kind used in ambulances, the connects to the patient through an intubation tube.

“It’s a second-choice compassion device,” Eliram said. “This is your plan B in the hospital, once you’ve exhausted all your $40,000 machines.”

Of course, one is tempted to ask as to whether there will be a demand for double-blind, placebo control group testing to “prove” the efficacy of such a device before it should be deployed.

To which the obvious answer is, no. No, as it would be unethical to treat someone dependent on artificial respiration with a deliberately ineffective treatment (apart from “belief kills and belief cures”). No, because the obvious near- Business as Usual baseline is a very tight stock of US$ 40 – 50,000 ventilators and/or to deploy a huge proportion of skilled staff to manually pump ventilators on a 24/7 basis (manually pumped Ambu-Bags are designed for short term emergency or bridging use), when they could be better deployed to other urgently needed tasks. No, because we can trace the dynamics at work and can see the rationale’s soundness.

In short, the Gold Standard fallacy is exposed yet again.

There is no one size fits all cases and circumstances Gold Standard way to validate innovative treatments.

What is arguably a more valid approach is to extend a SWOT-driven, sustainable development strategic decision model to the context of deciding whether a medical treatment innovation credibly offers an improvement over the BAU-baseline expected future, then using this to drive a robust strategic change process. As I have illustrated:

I trust this note will be helpful.

Let’s trust that this and similar devices can reach Africa in good time, with the sort of magnitude of Covid wave being feared. END

PS: This video is very similar to the recent one on using UV to kill pathogens in breathing passages; it even extends to the similar context of assisted breathing. Is YT going to “kill” this one too for violating its [nebulous?] “standards”?

29 Replies to “A low-cost ventilator based on the Ambu Bag (do you think a “Gold Standard” Placebo control is needed . . . )

  1. 1
    kairosfocus says:

    A low-cost ventilator based on the Ambu Bag (do you think a “Gold Standard” Placebo control is needed . . . )

  2. 2
    kairosfocus says:

    Do we see how the SWOT-based, BAU vs ALT strategic decision making model (as opposed to one size fits all “Gold Standard” Placebo Control frameworks) applies to the decision to develop, evaluate and then deploy this or a similar innovation?

  3. 3
    kairosfocus says:

    Countdown to banning?

  4. 4
    martin_r says:

    speaking about low-cost instruments, have a look at another one,

    it almost sounds like a joke:

    “Snorkel masks transformed into HIGH-GRADE protection by researchers from The Czech Institute of Informatics”

    https://www.reuters.com/article/us-health-coronavirus-czech-snorkel-mask/european-researchers-retrofit-snorkel-masks-for-coronavirus-fight-idUSKBN21H2Z5

    how much do these snorkel masks cost? $14.95 ? :)))

  5. 5
    kairosfocus says:

    MR, that’s a conversion into a gas mask:

    To help healthcare workers, a team from the Czech Technical University (CVUT) worked with volunteers to add military-grade filters to snorkel masks, which are meant for holiday swimming and typically sell for around 600 crowns ($24) in local stores.

    The researchers said that tests had showed the retrofitted masks surpassed the protection of masks carrying FFP3, considered one of the highest grade filters.

    KF

    PS: Would you demand double blind placebo control testing before taking such as credible?

  6. 6
    Seversky says:

    The idea of adapting snorkeling masks occured to me after seeing a clip from the movie Avatar. If you remember, humans on the alien planet had to wear close-fitting breathing masks when they went outdoors which looked a lot like snorkeling masks. The problem, it seemed to me, was that such a tight-fitting whole face mask would get very uncomfortable if worn over an extended period.

    Designing low-cost ventilators is an excellent idea and, as you say, it seems to have inspired a lot of innovative approaches.

    The “gold standard” when applied to the testing of novel therapeutic agents is not a fallacy, Best practice in clinical trials should always be to strive for the most rigorous application of measures designed to exclude any confounding influences – basically, to filter out as much “noise” as possible so that the clearest possible “signal” emerges, if there.

  7. 7
    kairosfocus says:

    Sev, when used in an exclusionary or unethical way, it becomes a fallacy. KF

  8. 8
    jerry says:

    I believe that 95% of people in New York City over 65 with C19 who were put on a ventilator died. So how effective is it?

  9. 9
    Latemarch says:

    Martin@4:
    You can pick one up at your local Walmart for $29.95. The filter will run another $10 or $11 and need to be replaced each day. There will also be costs to decontaminate the mask after each use. The outside will be contaminated with virus and there’s almost no way to remove it that won’t result in the inside of the mask picking some up. A bath in bleach water should do it. But all in all pretty cheap.

    KF@5
    What would the placebo be? A mask with a fake filter?
    I almost feel like you’re setting up a strawman argument here. Of course no one would do a double blind placebo trial against a potentially lethal virus. I guess that is your point.

    In the real world you would compare it to current best practice which would include an N95 mask , full face respirator, and positive pressure suit. All three probably provide good protection when properly used. It’ll probably come down to factors like cost, comfort and ease of proper use.

    I can’t imagine a double blind placebo controlled trial of that ventilator against what? The same ventilator without the valves as placebo? Hard to blind it. Everyone attending the patient would still know which was which from just cursory observation. Some proposed trials just can’t be physically or ethically done.

    A lot of new drugs are done the same way. Compared against current best practice rather than placebo. The calls for a double blind placebo study of HCL would appear to be a cynical political ploy.

  10. 10
    jerry says:

    A lot of new drugs are done the same way. Compared against current best practice rather than placebo. The calls for a double blind placebo study of HCL would appear to be a cynical political ploy

    The current best practice to treat C19 is to do nothing. And let immune system fight disease. So this study for HCQ has been done. The use of ventilators is just an attempt to prolong life in the hope the immune system wins.

    How callous/cynical is this given there are known effective treatments out there?

  11. 11
    kairosfocus says:

    LM,

    >>You can pick one up at your local Walmart for $29.95. The filter will run another $10 or $11 and need to be replaced each day. There will also be costs to decontaminate the mask after each use.>>

    As an asthmatic etc, I am using an industrial mask and using glasses as eyeshields [I got cheap swimming eyecups if I have to go there]. We are using the cartridge as a particulate filter so unless one is in a high exposure envt daily replacement is needless in my view.

    What I do is I have a spray bottle with 91% — 70% is probably better as it evaporates more slowly — isopropyl alcohol and spray inside and out, strap and cartridge on removal until visibly wet. The cartridge absorbs alcohol and that likely sanitises it too inside. (A second mask has a felt-like filter which when I use it for lighter duty, I treat similarly.)

    I gather rubbing alky may be hard to get. I suggest Everclear 150 to 190 proof or the like neutral grain spirits. For, I gather liquor shops are still open.

    Or, good old J Wray and Nephew “tamed” overproof at 63% ethanol by volume [the old version was notorious for men drinking a flask and dropping dead]. Charley’s has the real deal still at Nope, you got to go the distillery route looks like, 190+ proof, Johncrow ******* — don’t ask for the rest of that story!

    I think there are straight out gas masks on sale too.

    I also suggest home made cloth face masks with a filter pocket, with any reasonable filter. I figure the felt-like paper-cloth in some wet wipes should be good enough for droplet control. We are not talking N95 here.

    I find the N95 used at lower intensity could be similarly treated (for nurses etc, change x times per shift makes sense) . . . I have one too, but don’t like how it forms a pocket of palpably hot and humid air. I see a lot of people almost unconsciously sliding it off the nose due to discomfort.

    >>What would the placebo be? A mask with a fake filter?>>

    That would work

    >> I almost feel like you’re setting up a strawman argument here.>>

    I only wish that were so. I am exposing just how ill advised the Gold Standard fallacy is in the face of a highly contagious, fast moving, lethal plague.

    >> Of course no one would do a double blind placebo trial against a potentially lethal virus. I guess that is your point.>>

    Substitute, HCQ + Azithro-based cocktails and the Raoult etc case studies and, BINGO!

    >>In the real world you would compare it to current best practice>>

    DOUBLE-BINGO!

    That is precisely what I have argued for as the proper way to view the case series data being developed, with the near business as usual baseline of treat it like Flu with complications. Note here: https://uncommondescent.com/ethics/are-double-blind-placebo-controlled-studies-the-rightful-gold-standard-so-that-whatever-does-not-measure-up-can-be-discounted-or-dismissed/and the example of Gold Standard Fallacy at Guardian here: https://uncommondescent.com/ethics/guardian-exemplifies-the-placebo-control-gold-standard-fallacy/ with my further discussion here https://uncommondescent.com/ethics/on-scientific-methods-and-alternatives-to-the-placebo-control-is-the-gold-standard-view-in-the-face-of-pandemics/

    Hence, the decision making framework in the OP.

    >> Some proposed trials just can’t be physically or ethically done.>>

    Again, precisely.

    >>A lot of new drugs are done the same way. Compared against current best practice rather than placebo. >>

    Yup, that’s common sense decision making.

    >>The calls for a double blind placebo study of HCL would appear to be a cynical political ploy.>>

    I am afraid you may have an all too serious point. And, with lives and a viable economy [thus, lives again, this time by the dozens to hundreds of millions if depression triggers war] on the line.

    KF

  12. 12
    kairosfocus says:

    Jerry, you tell me. KF

  13. 13
    Bob O'H says:

    Jerry @ 10 –

    How callous/cynical is this given there are known effective treatments out there?

    No there aren’t! There are claims that some treatments are effective, but the evidence isn’t convincing. On another post, Denyse wrote

    After the smoke clears, we need to address the fast that we were constantly told to trust experts who were often wrong.

    At the moment, it’s possible that Zelenko and Raoult will be two of those incorrect experts. It’s only through proper trials that we’ll find out if thy were wrong or not. Although at the moment it’s not looking great for HCQ as a treatment, the evidence isn’t definitive.

  14. 14
    kairosfocus says:

    BO’H: The issue in a trial of fact is not so much whether a claim is possibly wrong — as is in principle true of most of science — but whether it has enough warrant to be credibly right so that with serious issues in the stakes, one would rightly treat it as established. In this case, we are talking of 1,000s of cases cumulatively, showing a consistent pattern that early treatment with a cocktail reduces fatalities by perhaps 90+ percent relative to the baseline de facto treatment. Also, where there is clear evidence of strong, progressive response over several days, backed up by known chemical capability and ability to go into the body and its tissues in active concentrations. Several mechanisms are on the table, where at least some may be working in parallel. Also, side effects are manageable as shown by 65 years of clinical use. KF

  15. 15
    jerry says:

    No there aren’t! There are claims that some treatments are effective, but the evidence isn’t convincing.

    Yes, there is. There is a fairly large amount of reported data, all positive.

    Although at the moment it’s not looking great for HCQ as a treatment, the evidence isn’t definitive.

    Everything I have seen points the opposite way. I’ve seen nothing negative so far.

    Again and again. Same irrelevant and wrong statements.

  16. 16
    kairosfocus says:

    F/N: David Gornowski’s note on the US “Gold Standard” process for drugs trials:

    New drugs cost a billion dollars and 10-15 years to make it through the FDA approval process. This regulatory hurdle precludes natural substances that cannot be patented from being properly researched and tested for illnesses because companies cannot afford the cost to prove the efficacy of something that any organization would be able to sell afterwards. This top-down monopoly approach to medicine can leave the world on its heels—not enough clinical trials on natural substances and patent-dependent, new FDA-d drugs and vaccines years away—during a pandemic like the one we are in now.

    That’s called, ceding the OODA loop to any viral pandemic pathogen that comes along. Such as SARS2.

    The system is patently broken and desperately needs to be fixed.

    We need to go back to the ethics, epistemology and inductive logic related to creating credible, empirically grounded knowledge and come up with a sounder solution.

    KF

  17. 17
    Seversky says:

    Raoult and Zelenko may be right or may be wrong. There’s only one way to find out for sure. Yes, trials are slow, maybe too slow, but just taking them at their word is being too credulous in my view. People get things wrong, even with the best of intentions. Think Andrew Wakefield.

  18. 18
    JVL says:

    Kairosfocus: The issue in a trial of fact is not so much whether a claim is possibly wrong — as is in principle true of most of science — but whether it has enough warrant to be credibly right so that with serious issues in the stakes, one would rightly treat it as established.

    Surely in a trial of fact the issue is what is true and what works.

    In the case of HCQ I hope we will know soon. And hopefully all participants here will accept the results whatever they are. I’m trying my best to take all the data in, evaluate it for quality and build an evolving conclusion. Evolving because we must accommodate new data.

  19. 19
    kairosfocus says:

    JVL, our problem is that inductive generalisations or explanatory frameworks are always open to adjustment, identification of limitations, corrections and outright replacement. That is a weak form of the pessimistic induction. We can recognise empirical reliability so far, and may see there is a chance or even credibility of truth, but an abstraction of a pattern will always be provisional. In significant cases that may rise to moral certainty so that one would be derelict to treat as false on evidence in hand, but explanatory constructs such as scientific theories or forensic conclusions etc are open ended. That is part of the challenge we face as human knowers. In short, credibility and/or certainty of empirically rooted conclusion comes in degrees. KF

  20. 20
    kairosfocus says:

    Sev, Dr Raoult and Dr Selenko et al are seeing such a strong and repeated pattern that it is highly unlikely to be a chance fluctuation. It is credible, at this stage, that early intervention with a cocktail involving HCQ and Azithromycin [or similar compounds] with Zn supplements and vits C and D, is an effective treatment for Covid-19. Where, BTW, DV I need to follow up a bit on Azithromycin, on some info recently noted on its activity patterns beyond “simply” being an antibiotic. KF

  21. 21
    JVL says:

    Kairosfocus: our problem is that inductive generalisations or explanatory frameworks are always open to adjustment, identification of limitations, corrections and outright replacement.

    Yes, which is why I wait for solid, viewer-independent results.

    We can recognise empirical reliability so far, and may see there is a chance or even credibility of truth, but an abstraction of a pattern will always be provisional. In significant cases that may rise to moral certainty so that one would be derelict to treat as false on evidence in hand,

    Yes again, which is why I hold out for results that are view-point neutral.

    but explanatory constructs such as scientific theories or forensic conclusions etc are open ended.

    Yes, true of all data which has to be looked at and evaluated.

    That is part of the challenge we face as human knowers. In short, credibility and/or certainty of empirically rooted conclusion comes in degrees.

    I’d like to think we’re both looking in the same direction. I hope so anyway. We both want to be sure of what is real and true and what is not. Sometimes we have to make preliminary judgments but we have to acknowledge that our views might have to change based on the arrival of new, solid data.

    I suspect we might disagree, sometimes, on what is solid data but generally we have a similar value system. Like you I am hopeful that HCQ turns out to be efficacious and genuinely beneficial to those suffering from COVID-19. Where we disagree, I think, is when we are both sure it is beneficial.

    I don’t want to argue about that since we seem to have different ‘lines in the sand’. We’re not going to change each others’ minds or greatly affect the decisions various governments make. And I promise that I will not be overtly belligerent if my view turns out to be more better nor will I make lame excuses if your perspective is closer to the truth.

    All I can say is: until there are some good, solid, double-blind clinical trials then I, personally, am not going to make a final call. I will try my best to stay open minded in the mean time. Fair enough?

  22. 22
    Bob O'H says:

    kf @ 14 –

    In this case, we are talking of 1,000s of cases cumulatively, showing a consistent pattern that early treatment with a cocktail reduces fatalities by perhaps 90+ percent relative to the baseline de facto treatment.

    [citation needed]

    Jerry @ 15 –

    Yes, there is. There is a fairly large amount of reported data, all positive.

    Except for the stuff that’s not, of course. For example, the VA study. Really, be more careful about making statements you know are false.
    kf @ 20 –

    Dr Raoult and Dr Selenko et al are seeing such a strong and repeated pattern that it is highly unlikely to be a chance fluctuation.

    Indeed, but how do we know it’s not a bias on their part?

  23. 23
    kairosfocus says:

    JVL, case studies are objective enough. Especially by the thousands. I wonder, have you investigated to see just what Dr Didier Raoult is? KF

  24. 24
    kairosfocus says:

    BO’H, the facts and references behind that comparison have been repeatedly given and have appeared in tabulations here at UD. Second, did you note i/k/o exchanges for some days, the significance of EARLY intervention with a cocktail of active drugs? The VA study is in fact an example of how not to do a serious evaluation, as has been pointed out to you and explained. The bottomline I see is that when toxic polarisation enters and receives major media trumpeting, it clouds, poisons and distorts. KF

  25. 25
    daveS says:

    KF,

    I wonder if people are thinking about ways to integrate this technology that is being developed to create pop-up hospitals, similar to the ones the Chinese built at the start of this thing, but much more portable. Suppose SARS3 has just appeared in a remote location. Military cargo aircraft could transport and install such facilities virtually anywhere on the planet within 24 hours (perhaps that’s more in the realm of science fiction, but it might be a worthy goal).

  26. 26
    jerry says:

    Except for the stuff that’s not, of course. For example, the VA study. Really, be more careful about making statements you know are false.

    This is essentially a repeat of what KF has been saying to you. And I know that my statements have not been false. I suggest you keep away from such rhetoric.

    The VA survey is irrelevant. Also it is not a study but a survey of what different people did long past the time when the drugs should have been first administered. There was no attempt to classify at what stage of the disease that the drug was administered. Which makes if faulty even as a measure of late stage use of the drug. We also know they were the most severe but not by how much. So it is not negative information. It is bad information that you are claiming I am making false statements about. Even if it was good information, it would be irrelevant information. You have been told that.

    HCQ and HCQ and zinc are meant to be administered early in the infection to prevent hospitalization. Symptoms usually show up around 5 days after infection unless the infected person is asymptomatic. Hospitalization usually occurs after 12 days but is sometimes longer before they enter. It is during this time between 5-12 days when HCQ and HCQ and zinc will be most effective obviously better the sooner.

    Zelenko claims near 100% success. You should listen to him sometime. He has been on a. lot of podcasts with his information. I do not know the status of Raoult’s tests. Take that up with Kairofocus who has been paying close attention to it. A lot of this started when a renown US infectious disease doctor in late March/early April reported he was getting almost 100% success keeping patients off of ventilators after given them hydroxychloroquine/azithromycin combo.

  27. 27
    Bob O'H says:

    Jerry –

    There was no attempt to classify at what stage of the disease that the drug was administered.

    Except where there was. From the manuscript: “To examine the association with ventilation, the time of hydroxychloroquine and azithromycin dispense was coded dynamically, before or after ventilator support.”

    We also know they were the most severe but not by how much.

    Except that we do. There’s a whole section of the manuscript called “Covariates” about this. These were used to estimate the propensity scores:

    Both sets of propensity scores were estimated via multinomial logistic regression of treatment group. All baseline covariates were included in the propensity score models. The propensity scores were entered into the outcome models with restricted cubic splines.

    You might want to read the pre-print carefully before commenting again.

    Zelenko claims near 100% success.

    He does, but his inclusion criteria seem to be so broad as to be meaningless: being in a high risk group, or having shortness of breath. How many of his patients in those groups actually have COVID-19?

  28. 28
    kairosfocus says:

    BO’H, ventilation directly implies a late stage in the disease, far beyond when the cocktail should be given to achieve high success. KF

  29. 29
    kairosfocus says:

    BO’H, he notes that his clinical diagnoses on cluster of signs/symptoms is about 90% against the lab test patterns, maybe the pandemic context is a factor in that high correlation. Raoult is working with lab confirmed numbers and is in the same range. All of this is telling a lot about whow we perceive issues, reason, come to and hold conclusions. Red flags are going up. KF

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