Sunday, February 11, 2007

Vaporized

The Vapotherm machine was a device that allowed neonatologists to give high amounts of humidified oxygen to babies through their noses, higher than we could with any other device except CPAP. I knew that some NICU's were using it in place of CPAP, so when one of my partners said, "Hey, we should get a Vapotherm," I decided to look for studies in neonates using it.

I found none. In fact, I could find reports of its use in only about 5 neonates, and certainly no well done study assessing its safety or effectiveness. I, and others, had concerns that we might be giving too much oxygen and air flow to a baby, without knowing the consequences. At our next neonatologists' meeting we managed to nix further attempts to get a Vapotherm for our unit.

A few months later, reports about an unusual infection in neonates using the Vapotherm began to surface. Shortly afterwards, the company pulled the product and the use of the Vapotherm in neonatology vaporized. I felt relieved that we had never tried it, although it bothered me that one of my partners wanted to get it when there was so little data available about its use in newborns.

This was an example of neonatologists not using evidence based medicine. Rather than looking for well done studies that showed the safety and efficacy of the Vapotherm, too many physicians said, "Hey, that sounds like a good idea," and started using it based on that. Unfortunately, the history of neonatology is littered with examples of good ideas that turned out to be harmful: large amounts of oxygen, steroids for BPD, phenobarbital for prevention of bleeding into the brain, and so on.

I'm not sure why some neonatologists thought it so necessary to use the Vapotherm without waiting for better evidence. It's appropriate that we always look for better ways to treat the babies, but let's evaluate them correctly. I think some neonatologists - and physicians in general - just don't have the scientific discipline to wait to evaluate a new thing before using it. Maybe we just want to be the first on our block with the new gizmo, but it''s better to be later and sure than to be early and cause harm.

20 Comments:

Anonymous chris and Vic said...

ND, if you HAD used Vapotherm (or any of the other unproven meds or treatments), what would you do, besides stopping their use, to follow up? Would you contact former patients who had had the treatments? And what would you say to them? What do you believe is our ethical responsibility if we have used a med or treatment in the past that is subsequently called into question or "outlawed" after it was found to cause harm?
Chris and Vic

10:58 PM  
Blogger Lisa - Mum to Mitch & Harry said...

As a parent I understand that not every medication, procedure etc that occurs in NICU can be thoroughly discussed with the family at the time. Emergency situations necessitate a quick response - and I would much prefer something was done without my consent, than nothing done at all.

HOWEVER, it is frightening that some of the 'treatments' given to the most fragile of patients (prem neonates) are not as a result of evidence based practice - and that parents are kept in the dark as to exactly how experimental these treatments may be.

Surely as parents we have an absolute right to be kept informed of the risks and benefits of all treatments in NICU. And we have the right to demand honesty from health practitioners.

I know in our situation with twin 24.6 weekers we sometimes felt overwhelmed by the amount of information we received each day, but we were grateful for the constant updates. We were also part of discussions when various treatments were being planned for both boys - and we were informed when these treatments were 'experimental' or carried an unknown degree of risk.

Thank you ND for giving us an insight into your own experience.

A grateful premmie mum,
Lisa
mum to Mitch & Harry
now 2 1/2 years old

11:16 PM  
Anonymous Dianne said...

ND: Do you think that there is a certain reluctance to perform randomized controlled trials or, indeed, any kind of clinical trials on premies, perhaps because of fear of what might happen to the group that got the treatment that turned out to be sub-optimal? I've often heard it said that it is difficult to impossible to perform medication trials on pregnant women and children because of fear of the consequences if something bad did happen (who wants to be known as the company with the next thalidomide style disaster?) and have some suspicion that there might be a similar problem in the care of neonates. Of course, in the end, this is worse for everyone, but the immediate consequences of doing a trial in which more babies died in one arm than the other sound daunting.

11:15 AM  
Blogger triantafilo said...

Hi, this is unrelated but here goes. I am interested in possibly pursuing a career in neonatology and was hoping you could share any interesting resources (books, websites etc) that I could look into that would provide information on a career in neonatology. Thank you. I appreciate it.

11:21 AM  
Anonymous Maria said...

My son's NICU used Vapotherm with success. He was born 2 years ago and was on vapotherm for the better part of his stay (113 days)

In the time that they used vapotherm they saw a reduction in NEC, less ROP and vapotherm is much less invasive than cpap.

If youlook at what they found as far as the vapotherm getting little ones sick it wa the water used to add moisture and the inability to clean the machine filter inbetween kiddos.

I am personally grateful that the neos that treated my son used vapotherm.

Oh and vapotherm is back, having been approved for use once again. My sons NICU is back to using them.

11:29 AM  
Blogger Ex Utero said...

Good post! but...

We use new ventilators all the time in the NICU and they're not each subjected to randomized trials. The thing that got the vapotherm in trouble was none of your original concerns, it was a design flaw that could in fact occur with any new ventilator that humidifies the air an infant breathes. They are all potentially resevoirs for bacteria if not designed to be self sterilizing (one that was complicated by the fact that respitory therapist were using tap water instead of sterile water in some institutions). Are we going to require every company to do an RCT before they come to market with a product that is in fact very similar to what already exists? What is that going to do to the cost of care?

It is an error to assume that an RCT will find every flaw and problem with a device or every adverse outcome with a medication. It is in fact, often the case that they cover them up because they aren't looking for those specific adverse outcomes. RCTs are designed to look at specific outcomes. The people who do them don't have crystal balls and cannot predict the unpredictable.

RCTs are the gold standard in research for determining efficacy and even for determining parity between therapeutic options, but it is a widespread falicy that they are the desired means by which we protect ourselves from adverse events. The phase II trial (which assures that there is generall safety with appropiate use) in combination with the registry of adverse events (after devices go to market) are our best methods for doing this. Unfortunately, that means that some patients will see a device (or a drug) that is not absolutely 100% safe, even though they are not enrolled in a trial. Buyer beware. It is true throughout all of medicine.

While I agree with the sentiment that there are some neonatal caregivers that are too eager to jump on the next greatest therapy wave, we cannot test every new "me too" device we bring into the NICU. There has to be some balance.

1:04 PM  
Anonymous Chris and Vic said...

Forgive me if I sound like a broken record (if anybody still remembers records): If some of the treatments and meds are not proven 100% safe and effective, but you might need to use them in a bind, just put that into the consent.
Something like, "According to the most current data available, treatments and meds are generally safe and effective, but there are no absolute guarantees." Or something like that.

As Lisa, Mum to Mitch and Harry, said, she had frequent conversations with neonatology, and good communication will assure parents that their childrens' physician is doing his/her best, analyzing, making hard choices perhaps, at times taking the outside chance.
Chris and Vic

4:26 PM  
Blogger NeoNurseChic said...

We used vapotherm, and did not have any of the problems that were found at the hospital where the bacteria was found, but I agree with what ex utero wrote on this one. We always use sterile water for all of our respiratory equipment, and the bags are changed constantly. We also did routine cultures (lukens) on babies on vapotherm on the same schedule that we do them for vents.

Frankly - I really miss the vapotherm because cpap has a lot of problems that the vapotherm was able to avoid. First off - nasal breakdown and pressure on the eyeballs as they look like they're going to pop out of the head with the cpap on. And also - babies on cpap cannot PO feed, and if an infant needs to be on cpap for a prolonged period of time, then this prevents them from beginning to PO feed, and they may ultimately miss the "window". They can PO feed on vapotherm as long as their respiratory status is stable - and that was a wonderful thing.

On the whole, I really liked the vapotherm and I hope that we will use it again at some point. The high flow nasal cannula cannot go to the PEEP that the VT can get to.

On the subject of trials - I will once again state something that I'm sure I've said before. I mean - somebody has to do it. For these things to have trials done, doesn't somebody have to use them? Some institution has to go ahead and give it a shot. And yes - there are risks, but I agree with what chris and vic has written that there should be better wording in the consent so that parents realize that not all treatments have had extensive clinical trials and there are no guarantees.

I really did like the vapotherm, though!

Take care,
Carrie :)

8:14 PM  
Anonymous Anonymous said...

Two things:
1) I don't believe any baby was actually infected with the vapotherm bug...just the machines themselves...I remember looking at the MMWR...

2) Our NICU does not have "consents" for treatments/admission...how many NICUs do? The only consents are for blood, procedures (surgery), and clinical trials...

8:26 PM  
Blogger NeoNurseChic said...

Our NICU does have a consent to be treated in the NICU, which includes a list of the things that might occur. All babies who receive treatment in our unit must have this signed, even if they are just there for a 48 hour rule out sepsis or a few short hours for hypoglycemia.

I didn't read the study on the vapotherm - so my comments may be off base. But I was just surmising based on what I read here. At any rate - I still do not believe that our hospital had seen the problems that were noted with the vapotherm, but I could be wrong!

Take care,
Carrie :)

9:50 PM  
Anonymous Anonymous said...

I have no preemies (well, a 35 week son but he was fine at birth) but I can totally appreciate the view of evidence based medicine. My son developed Infantile Spasms just a few days after recieving a pertussis vaccination, so is exempt from them, but also, any new vaccine, such as the one for Rotavirus, my pediatrician would rather wait to see more information on them than just handing them out. I'm sure happy about that...the last time one was available she didn't recommend it for my son (he was in fragile health) and later it was found to cause many problems and was pulled.

Anyway...I wish more docs would do as my ped. Maybe some children could be spared some horrific outcomes.

9:22 AM  
Anonymous Bugs said...

Neo Doc, do you consider the new vaccine for HPV to be based on evidence? I'm wondering how they can determine the long range safety of a vaccine designed to prevent something for many years. I've heard it has only been tested for approximately 10 years and only on a small number of girls...can they really tell it is safe with that limited data?

Do you have any thoughts on this?

10:45 AM  
Blogger Laura said...

like neonurse where i have worked we had great success with vapotherm and i grew to prefer it. i was disappointed when the company voluntarily recalled it due to the machines themselves growing out bugs- no babies being infected but better to err on being too conservative.
like neonurse the standard is all humidified equipment uses sterile water which is changed out every 24 hours.
unlike neonurse, we do PO feed our cpap kids with n o issues...well okay feed does back up but we can work around that.
my own ex 24 weeker son spent several weeks on cpap at age 3 months and did just fine with his po feeds.
another aside is we have a set-up that is vapotherm-like. i like to call it ghetto-therm or mcgyver-therm but again the end results for our o2 dependent kids is all around far better than the cpap kiddos.our lead rt tells me that vapotherm is back and our unit is looking into purchasing some.
also for anonymous: the nicus i have worked in do have a condition and general consent for admission into the nicu. blood, surgery and special procedures call for a separate consent but all other standar nicu care in our unit is covered by the initial consents signed upon admission.

11:41 AM  
Blogger neonataldoc said...

I have to chuckle a little bit at the range of comments here. On the one hand, lisa-mum criticizes the use of therapies that are not evidence based, but on the other hand, we have at least three commentators singing the praises of the Vapotherm - all based on anecdotal evidence.

Ex utero has a point. We cannot test every new device,especially when it is only incrementally different from another device. But I think the Vapotherm was different enough that it deserves study. The high flow rates used are untested in these kids. There were some abstracts at the last PAS meeting I went to about the Vapotherm,and I'm guessing there will be more this spring at the next meeting.

Dianne, I don't think there is a reluctance to do good trials in premies. I think that neonatology has made tremendous progress in this area, with many well done, multi-centered trials done, in progress, or being planned.

Bugs, regarding the HPV vaccine (Gardisil), that's not my area and I'm not up on the data about it, but in general I think that most vaccines are safe and I'm going to see that my kids get it. Cervical cancer is no laughing matter.

Chris and Vic, I don't know the answer to your question. Let me think about it!

3:23 PM  
Blogger Lisa - Mum to Mitch & Harry said...

Dear ND,
My point is that if a treatment is experimental or has not been thoroughly researched then this should be made abundantly clear to the parents of your tiny patients.

Alhtough this is a slightly different scenario - When my son Harry required a different approach to ventilation with a ventilator which was being tested (for possible purchase)in the unit - I was faced with the possibility that this may be finally be the treatment which saved him. His lungs suffered enormously and I used to be able to pick out his chest x-ray across the room. My husband and I made the decision we wanted the doctors to try with this new ventilator, but we were aware that the staff had not used this ventilator before.

Maybe I have a simplistic view... BUT I believe communication and honesty made what was a dreadful journey, just a little bit easier.

Lisa
mum to Mitch & Harry

6:49 PM  
Blogger Emily said...

As a parent of a child (24 weeker) who spent a significant amount of time on vapotherm, I am thankful for the technology even if it did have issues. About 4 months into my son's NICU stay one of the neos said that it looked like some of the vapotherm machines at another hospital in town were growing nasty bugs and gave us the option of switching back to C-PAP. We chose the vapotherm because Noah prefered it so much. On C-PAP Noah spent most of his time either screaming or sedated and could not bottle feed. He spent so much time fighting the machine that he gained little if any weight and had no energy reserve for the next issue that came up. On the vapotherm he was noticably more comfortable. Many of the treatments my son received were not without risks, and we understood that. We were not tricked or coersed - we were kept well informed and chose to accept the risks to save our son.

1:55 PM  
Blogger Kristina said...

Your concerns are understandable, but I must say that I'm thankful my daughter was able to be on the Vapotherm. She had no side effects from it, but it made her soooooooo much more comfortable! The CPAP machine bothered her a great deal.

2:13 AM  
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