The Undersea and Hyperbaric Medical Society (UHMS) and the American College of Hyperbaric Medicine (ACHM) have endorsed an updated position statement on the use of HBO2 for COVID-19 pneumonia (follow this link for the full statement).
It’s long statement but worth reading. These societies are now on record that HBO2 can be used for COVID-19 related hypoxia outside of an IRB approved clinical trial, on a case by case basis. HBO2 (which I abbreviate “HBOT” – sorry for the variations) makes obvious physiological sense in the treatment of hypoxia. In fact, HBOT has been used for a variety of hypoxic conditions for many decades. (Read this post for more on the physiology.)
We need and want prospective trials to be performed which will enable us to determine whether HBOT can improve the outcome of patients at risk for COVID-19 related intubation. (Here are the results of one preliminary study). However, given how safe HBOT is, we don’t want patients to be denied the chance to undergo treatment if they are near a facility that feels it can provide it — simply because there’s no formal research protocol in place. Even though COVID-19 is an “off-label” indication for HBOT per the FDA, it is NOT unethical for a physician to adminster HBOT for off-label indications. Physicians use medications and devices “off-label” nearly every day. That’s considered the practice of medicine. The key to providing off-label HBOT in an ethical way is to focus on the elements of the informed conset. I have reviewed this in detail.
We are not encouraging the use of HBOT for patients who are severely hypoxic with COVID-19 pneumonia, but both hyperbaric professional societies have stated that it is a reasonable and ethical option, regardless of whether the institution has an IRB approved research protocol. Although we may not have access to data on the outcome of patients treated on a case by case basis (since they are not part of a clinical study), the thing we care about most right now is saving lives.
Unfortunately, we can’t be sure that the necessary research on HBOT will even be possible. Oxygen is not made by a pharmaceutical company so there is no corporate sponsorship for clinical trials. HBOT is not part of the current Congressional funding for COVID-19 research. It’s a treatment that has no power-brokers behind it. While I am saddened by the lack of funding for HBOT research, I am glad to see this position statement about off-label use come out. I hope that practitioners and hospitals will read it as “permission” to use HBOT on a case by case basis as clinically appropriate, if their facility feels it is able to do so.
See these articles in popular press for more information: