The Long-Term Oxygen Treatment Trial

Posted on October 26, 2016 |

The National Heart, Lung and Blood Institute (NHLBI) and the Centers for Medicare and Medicaid Services (CMS) today, announced the publication of the long awaited results from the Long-Term Oxygen Treatment Trial (LOTT) in the New England Journal of Medicine.

Long-term oxygen treatment has already been shown to improve survival and reduce hospitalizations in those with COPD and severely low levels of blood oxygen (i.e. if your saturation rate is equal to or less than 88 percent at rest). Oxygen treatment may also be prescribed if COPD patients have a “moderately low” oxygen saturation rest that falls below 90% with activity or when sleeping. Until now, there was little research that told us whether or not oxygen for this moderate group with moderately low saturation levels at rest (between 89-93 percent) and below 90 percent with activity was beneficial.

LOTT enrolled 738 people with COPD who had moderately low oxygen saturation levels at rest or during activity in a randomized clinical trial where half of the group was prescribed oxygen treatment and half was not. The study found that on average, the patients who were prescribed oxygen treatment received no additional benefit to survival, hospitalizations, worsening symptoms or to quality of life. That means that based on this study, for most COPD patients with moderately low levels of oxygen saturation, oxygen use is not beneficial. At first glance it is easy to be surprised by these results, especially as it relates to those patients who use oxygen during activity. You may fall into this group and find it hard to imagine getting on that treadmill in the morning to get in your steps without sliding on your oxygen.

While researchers, clinicians and we at the COPD Foundation take some time to examine the LOTT publication released this evening, the MOST important thing to know is that the study examined GROUP effect. That means that it measured an average effect for all those in the study and was NOT intended to assess individual responses to oxygen treatment. The decision whether to start oxygen treatment is one that should be an informed, shared decision with your healthcare provider.

Another thing to cross off the list of immediate worries is whether your oxygen will still be reimbursed by CMS. The coverage for oxygen treatment should not change as a result of this study, as current coverage already includes those whose saturation falls below 90% with activity. CMS has indicated that it does not have intentions of reevaluating their coverage standards. We will be sure to reach out to CMS as we digest the LOTT publication to ensure that they understand the importance of continuing to provide flexibility in oxygen coverage and hope that others who pay for healthcare follow their lead.

Lastly, the LOTT publication reinforces the need for investing in COPD research and public health efforts that will help prevent COPD, improve the quality of care for patients and speed the development of new treatments and one day a cure. The COPD National Action Plan will be our platform for seeking those changes over the coming years. We hope you will join us and lend your voice as advocacy activities kick off after the Plan is launched early next year.

You can read more about the LOTT results on the NHLBI website here. Let us know what questions you have as you read more about the study’s results and we will be sure to work with our research and clinical advisors to answer them throughout the week.

23 Comments

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Made Pramana

I think it's good to have a study to assess our oxygen at rest, at exertion and sleep. From the oxymeter, my oxygen saturation at rest is 93. I never have a study to assess my oxygen. I asked my doctor about this and he said that too much oxygen can "harm" you..
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- AlinPerry
  
  I've never heard this and would like to know why???
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- Scott Cerreta, BS, RRT
  
  Made, the comment from your doctor is related to two situations.
  
  1. Oxygen toxicity. This is a phenomenom that may occur in rare situations with high flow and high concentrations of oxygen. Typically, this may occur with long-term ventilator patients in the ICU. This is not associated with low flow oxygen used in teh home for treatment of COPD.
  
  2. The Hypoxic Drive Theory. Basically, the theory states that if patients oxygen levels are too high, then they will lose the impulse to breathe. This is rare and only thought to occur in those known to be CO2 retainers.
  
  This is a very controversial topic. All the evidence I have seen disproves the hypoxic drive theory and frankly that is why the theory has never moved passed "theory" in over 60 years. Unfortunately, the medical community has not embraced the evidence on this theory and it remains controversial today. What really occurs is that a patient goes into respiratory failure and it goes unrecognized because oxygen saturations are in the normal range when the patient becomes unresponsive. Sats are easy to monitor, so if it is normal HCPs thing everything is fine, but there are other assessment values that must be monitored. So, people call this the hypoxic drive effect. I call it unrecognized respiratory failure and a tragedy in patient assessment.
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- PharStarr
  
  Please do not let anyone scare you about the "Hypoxic Drive Theory". it was started by a man on stage talking to a large number of people who believed his "Theory" about a study of just a few people, and the misinformation spread like wildfire. All of the typical medical schools picked up on it and now it threatens the lives of most every COPD patient out there because it is "THEORY" and UNPROVEN.
  Please read here at the following link, and after doing so, please spread others and help try to stop the misinformation and threat to millions of lives that depend on oxygen every day to survive. THANKS!
  https://respiratorytherapycave.blogspot.com/2015/01/why-is-hypoxic-drive-theory.html
  
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- Rachel72
  
  My husband and I were told that for COPD patients high O2 saturation isnt a good thing. The high O2 saturation cause excess/faster build up of CO2 in the lungs. Its the exhaling of the CO2 out of the lungs that is the larger issue. If airsacs are full of CO2, O2 is not absorbed properly regardless of the concentration because the damaged lungs cannot expand fully to accomodate both the buildup of CO2 and the needed O2. We were actually told to keep his O2 saturation at 92-94 and concentrate on deep exhales periodically to help dispell the built up CO2 in the lungs throughout the day. In the hospital, they peg it to max and want it as close to 100 as they can get it! Weve been told this now by two seperate pulmonologists in two different states. As for O2 therapy, its not to "make you feel better" in many cases, its to ensure your brain and body get the correct level of oxygen to keep things healthy and functioning correctly. It helps aide your heart from working overtime and shutting down from over exertion (heart attch!). Some COPD suffers need O2 therapy constantly, others during states of activity and bad days.
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- Jean IA State Captain
  
  Rachel72, please read Scott Ceretta's post above regarding the "hypoxic drive theory". The person who told you that high O2 saturation levels aren't good for COPD patients subscribes to that theory. As a COPD patient and advocate, I believe that theory is responsible for a lot of right heart and brain damage among COPD patients who were told never to turn their O2 up higher than 2 LPM, and as a consequence, had saturation levels low enough to do permanent damage. DO NOT listen to people who make such claims. If a doc, especially a pulmonologist, is making those claims, please move as fast as you can (with COPD, we generally can't run!) and find another doc who keeps up with current research and knowledge.
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HIcopd - Hawaii State Captain

There are a lot of issues about the trial protocol and how patients were selected, which make it difficult to determine how useful the results are to apply to the general population of COPD patients. It is clear that using pulse oximeters are useful tools in being sure to remain properly saturated at all times and avoid health risks that can be associated with being poorly saturated. It is expected that more discussion about this study and results will be released over time, as the study did cover 42 different centers.
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- Curious, what were the issues with the study or is that what will be coming out in due time.
  
  Reply
- Karen Deitemeyer - Florida State Captain
  
  clipper - here's a link to the complete study:
  
  http://www.nejm.org/doi/full/10.1056/NEJMoa1604344
  
  Reply
thank you Karen
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abeeaitch

My oxygen levels fall pretty low during activity, but where-as I feel OK during relaxation and sleep periods (except late night before bedtime when my lungs are just plain tired and stressed out, and my evening dose of Symbicort doesn't work the same as my morning dose) I haven't been tested during down times for years. After many years of resistance I've finally relented and allowed my Dr. to prescribe a generator and tanks. Even though portable I find the hassle of manipulating the tanks and lines to outweigh any possible benefit, so I've not used them. The generator I use occasionally. It's vaguely comforting during instances of outright respiratory distress but it certainly doesn't achieve the glowing and optimistic prognostications as promised by the medical professionals. As it turns out Oxygen Therapy seems not to doesn't increase my capacity, absorption, endurance or capabilities and the nose piece irritates my nostrils. I've told my Dr. several times about my dissatisfaction but he lacks the ability to wrap his mind around it. I'm generally disappointed but this article provides some interesting confirmation of my personal experience. Thank you
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- HIcopd - Hawaii State Captain
  
  Salter has designed new cannulas that are softer for the nose and over the ears which in my opinion are MUCH more comfortable. My O2 provider, Apria provided them to me at my request at no extra charge. They are called 16SOFT-7 (7 foot long cannula). It is a significant improvement I think. It is the only cannula National Jewish uses and soon will be the only type carried by Salter.
  
  How low is "pretty low" that your O2 levels fall to? Do you measure with your oximeter?
  
  Keeping our O2 levels at least above 90% as much as possible is a good way to stay as healthy as possible and avoid complications like heart problems from our heart having to work too hard trying to keep the body oxygenated.
  
  It can take some time getting used to new equipment. If there is a pulmonary rehab program available, try to get referred to one to learn how to use your equipment better or if there is something that might meet your needs better.
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- Dingledorf1
  
  Evidently your COPD is very mild and isn't limiting you in daily activities. I hope you never have to suffer the higher stages but if you do I believe you will change your mind on O2. I am stage 4 and probably wouldn't live thru the day without my O2 and the CO2 build up does happen and will kill you because as stated doctors don't look for it. I almost died from it. Just happens a recent graduate caught my condition in the ER in time. Please give the O2 a chance to become useful. It will sooner or later.
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HIcopd - Hawaii State Captain

Here's a link to Salter's webpage with info about some different types of cannulas, including the softer ones. I can really feel the difference with this one and really prefer it over the older ones that were less flexible and left indentations on my face.

https://www.salterlabs.com/flexi-soft-cannula
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- bjn
  
  I love the softer cannulas. It still leaves a mark on my cheek but not as deep and goes away quicker than the harder ones!
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This is a great post, it was a shocker to my family when we found out my dad had chronic bronchitis, i immediately started looking for things that would help him live a better life despite his condition, and i want to say that what has helped him a lot is purifying the air inside his house, he uses an air & room cleaning system named HYLA (www.hyla-us.com) and he swears by it, my mom uses it to vacuum but it is supposed to clean the air while it vacuums so that's awesome. I know that they also have air-purifying plants inside their home, to get rid of pollutants. I hope this is a good tip for someone who is looking for natural or not-so-natural remedies.
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muddleaged

They are just full of baloney! I have been on O2 for three months for exertion and sleep. Prior to the oxygen, I really tried to do three "things" a day. There was no way I could do four. Examples would be: baking bread, lunch with friends, going to the Y, grocery shopping, using the swiffer, doing two loads of laundry (including one bed change), making a special dinner, cleaning the bathroom. Today I made cookies, lunched with friends, exercised for 40 minutes, made chicken and biscuits (The ATK recipe is super!), went to bank and post office and candy shop. Spouse used to remind me to "take it easy" so I wouldn't get too tired to enjoy life. Alas, now I must hold up my end of the deal. This has made a HUGE difference in my quality of life.

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- emd
  
  how much did your oxygen levels go up with the O2? seems like it gives you alot more energy? I am new to this...so i appreciate hearing other people...thanks!
  
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- emd
  
  hi~~if I am at 90% it will go has high as 97% after 15 minutes on oxygen....has gone as high as 98% which i have not been at that level for probably two years...good luck to you! hopefully one day there will be more cures for this horrible disease.
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bjn

"The study found that on average, the patients who were prescribed oxygen treatment received no additional benefit to survival, hospitalizations, worsening symptoms or to quality of life" !!
Well, I find it is a GREAT benefit to prevent worsening symptoms (SOB) and GREATLY improves MY QUALITY OF LIFE!

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- emd
  
  me too!!
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NjB

I'm on oxygen and although the study says doesn't improve quality of life, or hospitalizations, I disagree!! Haven't had an "exacerbation" where had to go in hospital since I've been on it! Staying out of hospital definitely improves anyone's quality of life. Doctor who first prescribed it told me I'd live longer. Fev 46% now, Copd level 3, (been that level for years), diagnosed with copd 18 yrs ago. On oxygen for 12 years.
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- Jean IA State Captain
  
  Please understand that even the docs who did the study recognize that it was pretty flawed. The biggest flaw was that the study recruited people who were between 88 and 92 SpO2 and they would randomize you to either get O2 or not. There are a truckload of us who self-selected out because we weren't about to lose our O2. We knew the benefits we got from O2 and we weren't about to take a chance on losing our O2! So the people who didn't participate in the study were the exact people who know they benefited from O2 they already had. The people in the study didn't have any idea how they could use it to make life better for themselves......no one told them. So there were a lot of things wrong with the study......even though some idiot occasionally cites is, most of us know enough to know better.
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