ArticlesMaaret Castrén, Per Nordberg, Leif Svensson, Fabio Taccone,
Jean-Louise Vincent, Didier Desruelles, Frank Eichwede, Pierre Mols,
Tilmann Schwab, Michel Vergnion, Christian Storm, Antonio Pesenti,
Jan Pachl, Fabien Guérisse, Thomas Elste, Markus Roessler, Harald
Fritz, Pieterjan Durnez, Hans-Jörg Busch, Becky Inderbitzen and
Denise Barbut. Intra-Arrest Transnasal Evaporative Cooling.
A Randomized, Prehospital, Multicenter Study (PRINCE: Pre-ROSC
IntraNasal Cooling Effectiveness. Published online in
Circulation (Journal of the American Heart Association). August
2, 2010.
Article (PDF) » •
Editorial by Lance Becker, MD (PDF) » |
Abstracts |
H. Busch, H. Fritz, F. Eichwede, B
.Inderbitzen, D Barbut, T Schwab.
Intra-arrest cooling using a novel intra-nasal cooling method for
immediate induction of therapeutic hypothermia in Germany.
30th Annual International Symposium for Intensive Care & Emergency
Medicine (ISICEM), Brussels; Poster presentation (March 2010). (PDF) Good luck and let me know what you decide to do. Also, let me know what happens with Benechill. You should look over their Board of Directors and management staff and, if you approach them, have a letter perfect proposal that is the essence of professional and preferably tendered by the MOST INFLUENTIAL PERSON YOU CAN MUSTER. A stellar physician (published) and/or someone who KNOWS one of the Directors or Managers would be an enormous help. Believe me, I know whereof I speak. Mike Darwin
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Hi Mike,Thanks for your detailed response. Much appreciated as always. I have taken all your comments on board, and like you I agree a staged approach might be more feasible.I never got the book or CD you were going to send me. I remember you saying you were going to send them through - I think one was going to be a copy of Crippen's memoirs and the other was going to be a photocopy of ?Negovsky's book.Are the graphs you have quoted from the RhinoChill company's website or some other source?Chris CottonIntensive Care ParamedicSouh AustraliaChris,OK, here goes.Mostly, these is just my opinions and prejudices, so take them with a grain of salt. Secondly, my approach to animal and clinical research is IMMENSELY unpopular and considered 'unscientific.' Why? Because I believe in common sense and RESULTS, rather than nice clean papers with easily isolated variables; but where the patients die or fail to benefit maximally. I also like risk!Let's look at your situation, in particular. Good data (considering CPR research) now exist for cold IV saline AND for use of the RhinoChill. Both work to reduce mortality and improve neurologically intact survival. That work has been done already. Now, there is genuine benefit in REPEATING either of these studies to CONFIRM their validity, especially if you (or the world) have doubts about their validity; or you want to make the data more robust to facilitate clinical acceptance. Such studies BORE me to tears; that's a personal quirk. If I had wanted to go about spending my life validating the work of others, I'd have been a medical doctor working in some university setting. I want to explore and break new ground. Having said that, remember that a pioneer is someone with an arrow in his back or some weird and unknown micro-parasite in his body!Now, the fact is that NEITHER chilled IV saline or the RhinoChill are going to give cooling of ~3 deg C in under 15 minutes. The laws of physics, as well as ample animal and human experience, show that it just isn't going to happen. In consequence, if you REALLY want to achieve the Holy Grail of cooling 3 deg C as quickly as possible, you will have to combine modalities. THAT however, is easier said than done. Doing one new thing is difficult, doing two at once in a clinical setting is damn near impossible, but, importantly, NOT impossible. It comes down to how much risk you want to take and how much time and money you have.I think Wake EMS did it exactly right. They clearly understood that several modalities had to be combined to improve survival; high impulse continuous compression CPR, an airway impedance valve and intra-arrest cooling. Considering that most people are morons and intractably stubborn, they quite wisely decided to introduce these three interventions in a phased program, so that each modality could be digested and mastered and, of course, so that they could get a good signal from the data as to effect of each intervention as it was added. Finally, thy had ENOUGH PATIENTS to generate statistically valid data.What should you do? I don't know because I don't have all the facts and cannot be given them; much depends on intangibles like how good your paramedical staff is, what their attitude is, how keen they are to try stacked modalities, how your medical community will react, and so on. Human clinical trials very often live or die by these factors, rather than by their scientific or technical feasibility. If those factors are favorable, I'd do what Wake did; start with the modality you are most comfortable with and then ADD the RhinoChill. If you think you can get away with it, I'd add the gel cooling cap (which can be kept in the cold saline fridge) as a final intervention only after the first two are in place and working smoothly.The nice thing about this study design is that if you have problems, or cannot get enough patients for 'phase II', you can simply stop at phase I. Alternatively, you can do EXTENSIVE training with ALL the personnel involved using BOTH systems PRIOR to the start of the human trial. This is not nearly as good as real world experience, but if you at least have everyone thoroughly familiar with the hardware and protocol, the chances of a logistic meltdown, or revolt against 'complexity' of the whole thing are greatly reduced.All the data I showed, and those that are presented below, are from the published papers. A trick few people seem to know is to set the Adobe viewer to 400% or 800% and then copy the graphic you want to use. This captures the image at a very high resolution. (PDFs are compressed and by expanding the view you are decompressing the data soyou can copy it.) You can then paste it into any editing program of your choice and manipulate it as you like. I use Photoshop, Paint and Powerpoint. Powerpoint is great for adding text and arrows in a hurry. If you can master the basics of Photoshop, the world is your oyster.As to getting a machine from Benechill: GOOD LUCK! My guess is that you will find your limitation in protocol design is your ABILITY TO GET BENECHILL TO GIVE YOU THE TIME OF DAY. This is so because the costs of developing a new modality are so staggeringly high that a company can no longer afford even one negative trial. EVERY trial has to be positive and preferably 'perfect.' This means that the companies go for high profile institutions with big names (and a lot of them) and restrict access to their technology as if it were a CIA or MI5 secret the fate of the free world depended upon. Ironically, this is what, in large measure, sunk the Alliance partial liquid vent trials because centers of excellence tend to do everything well and PFC was thus put up against the VERY BEST of mechanical ventilation. Of course, in the real world MOST centers do a crappy job of preventing baro and volutrauma, and if Alliance had put PLV in those settings, they would have shown positive results AND THEY WOULD HAVE GOTTEN THE NUMBERS THEY NEEDED BEFORE LUNG PROTECTIVE VENTILATION WAS ON THE SCENE. In short, they would have had an approved product on the market today. And, while PLV is not the cat's meow for Tx of ARDS, it has plenty of other great uses that will now not be possible because it was never approved.And yes, you are right that temp measurement is going to be a big logistic problem. I have a number of ideas on how to deal with this, but they are not for discussion here. One approach I've used is to insert a soft vinyl clad TC probe approved for medical use into the external ear canal in a plug of the silicone putty-type swimmers' ear sealing wax. It's quick, effective and gives readings that are as accurate as Ttymps, albeit with a bit more lag. Other solutions are possible.Finally, most people end up taking baby steps because it is so much less work and so much safer. And, often they are forced to by logistics; my bet is Benechill is going to politely say "no," which is vastly better than Alliance's RUDELY saying "f-off!"It's a scary business to make a decision to go with a more complicated higher risk strategy. And, if you have no experience doing field trials, then unless you are VERY good and moderately lucky, you will probably not have a good outcome.Below is part of a book Chapter that deals with the RhinoChill I just wrote. You may find it useful. If you need any of the figures in it, let me know and I'll send them to you as high res JPGs.Mike DarwinPS: did you get the book & CD I sent you some months ago?