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+--- Thread: EVIDENCE OF AIRFIT P10 VENT OBSTRUCTION CAUSING HYPERCAPNIA (/Thread-EVIDENCE-OF-AIRFIT-P10-VENT-OBSTRUCTION-CAUSING-HYPERCAPNIA)
RE: EVIDENCE OF AIRFIT P10 VENT OBSTRUCTION CAUSING HYPERCAPNIA - mdmarmd - 02-25-2019
Well, I have been using the AirFit P10 since I got the AirSense 10 when I got on Medicare about 4 years ago. I still am using it and have been recommending it to my patients that have OSA. But I must say, now that I know these obstructions are not just an occasional inconvenience, but may present serious health risks, maybe I am creating a medical liability by recommending it.
Up until I got this hard data, I would just keep a backup P10 or my hybrid P10+ Nuance, especially during April and October when I am still using my 5th wheel at the lake. I had hoped, when I first posted my ALERT regarding possible re-breathing issues with Resmed Airfit P10, in December 2016 was that I would have verified if this was really a risk with capnography. Unfortunately, the software problems caused a two year delay in completing this project. If I had demonstrated significant hypercapnia, I had intended to file a MedWatch report with the FDA and let them do what is appropriate. As a physician, I am under no illusion that a company this big would take me seriously.
If anyone else that has experienced these blocked vents is so inclined I would encourage you to file a MedWatch:
MedWatch
With medical devices, as with reports about side effects with medications, you need to reach certain critical mass before the gears begin to move. A Lot of $ is at stake.
I hope to file my data in the next several weeks. I also will send my document to Kaiser Sleep Dept. here in San Jose.
I was restricted by the constraints of posting the report on this site, especially the short window for making edits. So it's kind of mangled. Also, the limits of the jpg files made the magnified photos more blurry than they really are.
I'm going to put together a PDF that will have the report with all the pictures, graphs, and charts so I can send it to Kaiser. If you'd like a copy when it's done, send me a PM.
As many have pointed out, apparently the majority of users are happy campers...
But perhaps a few of the ones who aren't, might have died??
I could see that if someone had a lethal event provoked by hypercapnia, it could easily be misconstrued as a cardio/pulmonary event, a CVA or a bad apnea event. If you have chronic health problems, have diabetes or are even overweight, there a lot of things a terminal event might be blamed on. There is a high association between OSA and other medical conditions.
Hulk is a perfect example of how things could be missed. Though I don't know if he actually experienced hypercapnia, he made a very simple, but accurate observation--over and over again--there is diminished or no expiratory flow through the vents!
As I mentioned earlier, you can prove this by simply holding up the dampened back of your hand near the vent. If it's not cool, there is no flow.
I too had had a terrible time adjusting to the CPAP, but my first symptoms of OSA were profound neuro-cognitive problems. I could talk with a patient I've seen for twenty years. And after 30 minutes, I'd turn around to make an appointment and not remember their name! So I knew I had no choice but to stick it out because, I told myself, "I need my brain!!". But my difficulties were from mouth breathing and profound xerostomia. My sleeping brain eventually said to itself, "keep your bloody mouth shut!" That's why, today, I can use a pillow.
In contrast, Hulk seemed much more distressed clinically with symptoms that didn't line up with the fact that his AHI had improved dramatically.
He posted:
"Over the period of a couple of weeks the fatigue increased to a point where, when I got up from a sleep period with the CPAP equipment, I was suffering fatigue like I have never experienced before and sometimes had a headache. It became dangerous to drive and I could not work. I would dispense with the CPAP equipment and go back to bed until lunchtime. I became concerned there was more going on than just acclimatisation?"
"I noted that I was waking up during the night with a higher respiration rate. Initially I thought it was just agro with the hose, mask head straps, noise etc. However, I also noted that there was venting out of the P10 Mast when breathing in but either very little or none, when breathing out! When I squeezed the tube on the exhale, it was very hard to breath out, upon releasing the tube it was easy to breath out. This lead me to concerns about re-breathing causing hypercapnia (carbon dioxide poisoning)."
He seemed to make every effort to dutifully follow everyone's advice. Yet, he described feeling the next day how I felt after 20 minutes of hypercapnia. It seemed he was even missing work. I don't think I could go to the office after the days of testing.
Yet the advice he received was not particularly helpful:
"...the advice received from Sleep Physicians and CPAP Technicians, getting acclimatised to CPAP is often a difficult process that everyone goes through and patience, tolerance and perseverance is needed."
"As promised, the feedback from the Sleep Technician and Physician in response to the question "is there an issue of re-breathing with the P10?":-
- "unlikely as it would be effecting so many people all over the world""
And he, at least had the benefit of this forum with very earnest and well informed members. Most would not be fortunate enough to have a support group.
Yet I believe only DaveResmed P10 really gave Hulk's concerns a full-throated defence.
Someone less fortunate might end up like the late Supreme Court Justice Antonio Scalia: Found with the hypercapiac equivalence of his, "unplugged CPAP" next to his bed.
So I guess all you P10 users will each have to decide for yourselves how to integrate these findings in your decision making.
Watch for symptoms. I didn't just feel tired or sleepy from the hypercapnia, I felt sick.
I for one, will be paying closer attention to signs of decreased venting. I will regularly "jet wash" my vents and keep them "microscopically" clean. (You can get a good USB microscope for about $35; search Amazon for "plugable digital usb microscope").
At least the element of dust can be reliably minimized. But Hulk's P10 was new as was DaveResmed P10's so there remains some risk from condensation alone it seems, unless these were "manufacturing variations", which Resmed said don't occur. (I didn't have the time to test just a wet P10.)
If yours is new, and failing to vent properly, replace it if you have insurance, but I would hold on to it as this might be the ones that the FDA would like to analyse.
That's about all the advice I can give you at this time.
I am still using mine "watchfully".
Doug
RE: EVIDENCE OF AIRFIT P10 VENT OBSTRUCTION CAUSING HYPERCAPNIA - cate1898 - 02-25-2019
Wow, that is certainly a lot of food for thought. I understood a large part of this post, although a bit of it got pretty technical for me. Thanks for posting all your findings and I will certainly keep this in mind as my most used mask is my P10's.
RE: EVIDENCE OF AIRFIT P10 VENT OBSTRUCTION CAUSING HYPERCAPNIA - Snoring Bear - 02-25-2019
(02-25-2019, 04:40 AM)mdmarmd Wrote: So I guess all you P10 users will each have to decide for yourselves how to integrate these findings in your decision making.
Watch for symptoms. I didn't just feel tired or sleepy from the hypercapnia, I felt sick.
I for one, will be paying closer attention to signs of decreased venting. I will regularly "jet wash" my vents and keep them "microscopically" clean. (You can get a good USB microscope for about $35; search Amazon for "plugable digital usb microscope").
At least the element of dust can be reliably minimized. But Hulk's P10 was new as was DaveResmed P10's so there remains some risk from condensation alone it seems, unless these were "manufacturing variations", which Resmed said don't occur. (I didn't have the time to test just a wet P10.)
If yours is new, and failing to vent properly, replace it if you have insurance, but I would hold on to it as this might be the ones that the FDA would like to analyse.
That's about all the advice I can give you at this time.
I am still using mine "watchfully".
Doug
Doug,
Thanks very much for your reply! Coincidentally, I got all my gear from Kaiser-Santa Clara last week. In fact, I'll be over there later this morning for something else. I just might stop by the Sleep Apnea Dept to ask for possible alternatives.
I suppose I could get the USB Microscope that your suggested and clean the mask daily, but that seems to be a bit of a hassle.
How lucky those of us dealing with Sleep Apnea have folks like you on this forum to help us get through our health challenge. And how lucky we are to have Apnea Board!!! Thanks again Doug!
RE: EVIDENCE OF AIRFIT P10 VENT OBSTRUCTION CAUSING HYPERCAPNIA - mdmarmd - 02-25-2019
Hie Snoring Bear,
I did not mean to imply a such a frequent cleaning schedule was needed.
I a jet wash every 3-4 months would be ample unless you live in a realy dusting environment. I've used two instead of one filter on my CPAP, and I am going to look into getting the hypoallergenic, ultrafine filters for my CPAP.
It takes about 10 jet wash my vents probably even less. The usb camera plugs into your laptop or PC and needs no special drivers. The exam would take a minute.
So the monitoring process would only be about 15 minutes/3-4 months. Not too encumbering I think. Much less time than you take to clean your tubing, etc,. (which I don't do much).
Be interested any feedback you get from your sleep doctor.
Small world, we are practically neighbors!
Doug
RE: EVIDENCE OF AIRFIT P10 VENT OBSTRUCTION CAUSING HYPERCAPNIA - Snoring Bear - 02-25-2019
(02-25-2019, 05:15 PM)mdmarmd Wrote: Hie Snoring Bear,Hi Doug. Thanks for the additional clarification! I talked to a lady this morning who handles the Apnea supplies at Kaiser-Santa Clara. Since they started me off with two masks, Eson2 and Airfit P10, she said I'd need to wait six months to change to another mask. Btw, she mentioned she has been using the P10 for 8 years without any problems. And she also mentioned that a high percentage of people are using the P10. - So I guess she must have thought I was crazy!... lol
I did not mean to imply a such a frequent cleaning schedule was needed.
I a jet wash every 3-4 months would be ample unless you live in a realy dusting environment. I've used two instead of one filter on my CPAP, and I am going to look into getting the hypoallergenic, ultrafine filters for my CPAP.
It takes about 10 jet wash my vents probably even less. The usb camera plugs into your laptop or PC and needs no special drivers. The exam would take a minute.
So the monitoring process would only be about 15 minutes/3-4 months. Not too encumbering I think. Much less time than you take to clean your tubing, etc,. (which I don't do much).
Be interested any feedback you get from your sleep doctor.
Small world, we are practically neighbors!
Doug
And yes, we're very close! I passed the San Jose Kaiser on 85 this morning to get to the Santa Clara Kaiser. I'm probably about 20 minutes or so South of you. Maybe we could meet one day... this is all new to me so I'm trying to learn all I can. Thanks again Doug!
John
RE: EVIDENCE OF AIRFIT P10 VENT OBSTRUCTION CAUSING HYPERCAPNIA - mdmarmd - 02-25-2019
Hi Snoring Bear,
Too bad you are stuck with those two options for awhile. I tried quite a number of nasal mask designs and found them so bulky. The higher anterior profile made them much more vulnerable to displacement if you turn to the side. The shear weight of all the extra silicon/plastic pulls to the side and they have to compensate for it by much beefier straps, using greater tension leading to facial marks (mine didn't fade until mid morning). It a good way to let the public know you have sleep apnea! I especially didn't like the nasal masks with the stabilising post on the forehead. That even left a red dot there that needed to fade as well.
That's why I came back to pillows, and why I felt the P10 had the best design for me. The greater area that contacts your face, the greater the potential for leaks because there is no two face anatomies that are alike. But the area of contact is minimal with pillows--only two little rings around the lip of the nostrils. Notice how apparently putting the extra silicon around the pillows actually seems to exclude the moustached, like myself,
(according to the previous poster regarding the Brevida.)
If the P10 is comfortable for you, I would say stay with it. Statistically, it seems the risk of a critical event is small. If you continue using it, I would recommend you make a faucet flush adapter and check it microscopically every quarter. $35 bucks is not much to pay for peace of mind.
If you don't wake anxiously panting and feeling short of breath and you don't wake feeling really lousy (not just tired) you are probably fine.
If you wake wondering if the vents are functioning, do a quick moist backhand check for flow.
Follow these simple guidelines and I think you are most likely safe.
Yeh, neighbors! I'm off the 85 Camden exit. Ever want to link up over this stuff, let me know.
Doug
RE: EVIDENCE OF AIRFIT P10 VENT OBSTRUCTION CAUSING HYPERCAPNIA - Snoring Bear - 02-25-2019
Doug,
Thanks for the additional info! The F&P Eson2 I have is not really that big. - Yes, it has the head straps like all masks, but they're light weight and relatively thin. However, I was glad to get the P10 last Wednesday as it doesn't hardly seem like a mask at all... very low profile! Plus it's easy to put glasses on over!
One of the good things raised by your research is the importance of keeping the P10, and all masks, very clean! I'll be sure to do that.
At Sleeprider's suggestion, I ordered a soft cervical collar for positional sleep apnea. I'll be trying it out tonight with the hope that it will help to lower my AHI's.
I know the area you're in pretty well. One of my favorite taquerias is at Hillsdale & Ross near Smart & Final. - I'll pm you after while to see if we could meet later this week. Maybe near Almaden...?
Thanks again Doug!
John
RE: EVIDENCE OF AIRFIT P10 VENT OBSTRUCTION CAUSING HYPERCAPNIA - Snoring Bear - 02-25-2019
Deleted duplicate post.
RE: EVIDENCE OF AIRFIT P10 VENT OBSTRUCTION CAUSING HYPERCAPNIA - Sleeprider - 02-25-2019
(02-25-2019, 06:20 PM)mdmarmd Wrote: If you don't wake anxiously panting and feeling short of breath and you don't wake feeling really lousy (not just tired) you are probably fine.
The panic, adrenaline, headaches, and rapid breathing, usually result in a strong reaction. A CPAP user would find immediate relief by removing the mask or nasal cushion. I don't doubt that the P10 mask vents may become occluded under some circumstances as shown in this post, but as far as we know, the problem is rare, and affected users have responded by removing the mask.
I have been using the P10 since 2014 when it was first released, and have not personally experienced this problem. I appreciate that we are finally learning the mechanism of blockage may actually be small particulate matter, rather than moisture or cleaning practices.
RE: EVIDENCE OF AIRFIT P10 VENT OBSTRUCTION CAUSING HYPERCAPNIA - mdmarmd - 02-25-2019
"A CPAP user would find immediate relief by removing the mask or nasal cushion"
SleepRider,
While I think this is true in general, my graphs show that I can sleep right through some of them., I think I know why, in my case, I persist through the hypercapnia events.
As I alluded to, I was struggling with profound neurocognitive deterioration at the time I was diagnosed. I had initially trained in family practice and had been taught there are two ways sleep apnea patients will present:
- They complain of excessive morning or daytime sleepiness despite adequate or even prolonged sleep time.
- The spouse kicks them out of the room and says you can't come back until you get your snoring fixed
But when my memory rapidly declined I got assessed and was told by the sleep doctor I had "mild" sleep apnea and it was up to me if I wanted to treat it. "Mild??" I am going to have to close my practice, can't remember my patient's names (after talking with them 30 minutes), can't drive safely and can't type properly and you classify it as mild?!!
So I bought a CPAP and had the worst possible 4 month adjustment period imaginable. Because I was a mouth breather (and didn't know it), I'd wake with the "parched desert mouth syndrome" where you wonder if you can peel your tongue off the roof of your mouth.
But I truly believed I was facing accelerated dementia and an early death if I didn't master the CPAP. If I woke fighting it, I'd say to myself, "you need your brain!" and I'd force myself to keep the bloody thing on. And once I seemed to teach my sleeping brain to keep my mouth closed (most of the time), it got better. I kept using it diligently for the next four years and never went a night without it. I don't think I ever consciously chose not to use it, such was my fear.
I say all this to say that I think I have very deliberately trained myself to resist opening my mouth or taking my mask off. Of course, I was starting with the Swift FX, and moved on to nasal masks, pillows and full face masks, and I don't think I've probably confronted hypercapnia until I starting using the P10. Adjusting to the quirks of using a CPAP and a particular appliance that doesn't quite fit is one thing but dealing will hypercapnia is entirely different. Yet I am sure I have slept through many events. Maybe, now that I am more enlightened to the risk, my sleeping brain will wake me up more often!
Also, I didn't mention in the main post that another at risk population for hypercapnia are those that use sedating or respiratory depressant medications, or even alcohol.
I have a ton of patients who have to use anxiolytic or sleep promoting medications. In my bipolar patients, I often need to use Seroquel or Ambien as they are notorious for having trouble getting or staying asleep. But the catch 22 is any thing that makes you sleep deeper may worsen apnea since it's more likely to occur in deeper or more relaxed sleep.
Any narcotics would be a risk as they reduce respiratory drive. Muscle relaxants like Flexeril and Robaxin might also be problematic.
All the benzos, Xanax, Ativan, Klonopin, Restoril, Halcion and Valium might reduce sensitivity to a rise in CO2.
It's one reason why, if I even suspect OSA, I get it ruled out so I don't have to worry that my meds will worsen it.
And those with COPD often develop chronically high CO2, which is why they become more dependent on O2 sensors rather than CO2 for respiratory drive. (That's why giving them O2 can turn their drive off.)
They might be way more tolerant of CO2 levels that we could never tolerate--so the bells and whistles might not go off. The high CO2 causes acidosis (high pH) in their blood and the kidneys compensate by making more bicarbonate ions to entrap the CO2.
I had really hoped to get some detailed technical and clinical input for my post. I contacted an anesthesiologist I knew, and I presented my data. But he made a disclaimer--that he had Resmed stocks--and I never heard back from him.
Sorry. As you can see, I can have a problem with verbosity. Maybe I should change my handle to "Verbosity" and you'll know not to open my posts.