InTroduction: Lessons Passed Down From A Leader

  William Fife, my father, passed away on October 13, 2008 at the age of 90. He was a hyperbaric physiologist, so I have been around chambers all my life. My earliest memories (late 1960s) were of the chambers at the School of Aerospace Medicine where he and luminaries like Jeff Davis performed research which laid the foundation for the field of hyperbaric medicine. Although it all seemed routine at the time, a new medical field was being born. Men we knew as friends and colleagues we currently refer to as “The Father of … ,” now that the histories of such things are written. That means that in one ‘clinical generation’ we have identified the physiological rationale for this therapy, defined in large part its clinical spectrum of use, and have begun to establish its cost benefit ratio. It began with a fairly simplistic understanding of tissue hypoxia. However, we now know that the mechanism of hyperbaric oxygen therapy (HBOT) is far more complex—it can even mitigate ischemia reperfusion injury. This has all happened in less than 50 years—a time where the field of medicine has changed dramatically—including how we gather and weigh scientific evidence.

  Over time the community’s understanding of wound care has evolved dramatically. However, improved local wound care, better control of bioburden, and other advances have not made hyperbaric oxygen obsolete. I recently reviewed the entire wound healing studies published from 1996–2006 and discovered that out of all of them (and there were hundreds), the only trials that did not exclude patients with critical ischemia, were hyperbaric oxygen studies. To date, hyperbaric oxygen therapy is the only non-invasive therapy which has been demonstrated (in RCTs) to raise tissue oxygen levels sufficiently to effect healing in patients with ischemia.

  It is important to remember that HBOT is unique in that it requires both the use of a drug (oxygen) and a device (a hyperbaric chamber). The optimal dose of the drug oxygen for each indication is still being determined, while the Food and Drug Administration regulates the use of the device. Unlike any other drug in use for wound care, oxygen is not made by a pharmaceutical company, substantially affecting the way in which research is funded. Furthermore, physics significantly limit how randomized controlled trials are performed. Without going into the math here, it is not possible to use compressed ‘air’ as a control because subjects at pressure are still breathing an increased partial pressure of oxygen, and the nitrogen present in the air can put subjects at risk of decompression sickness. Despite these challenges, thanks to the Baromedical Research Foundation, a large RCT on the use of HBOT in soft tissue radionecrosis has recently been completed.

  Hyperbaric oxygen therapy could also be a victim of its own success. Because it has been limb and life saving for many, patients hope to extrapolate its benefits to indications not yet proven. Perhaps in the future some of these indications will be substantiated, but in the mean time, how is the physician to respond to requests to treat unproven indications? Facility and staff certification processes are addressed in this issue. These topics are critical because there is still the feel of the ‘frontier’ concerning this specialty. The same would have been true for radiotherapy 50 years ago. Some day we may look back on this issue and say to ourselves, “A time when not every facility was accredited? Imagine that!” But for now, we must chart a course for our facilities and our staff members as this new field of medicine matures in the 21st century. We hope this issue will help you do that.