Dangers and Deceptions of Soft Hyperbaric Chambers

Portable air pressure bags (sometimes called soft hyperbaric chambers) were created and approved to treat mountain climbers suffering from altitude sickness. Portable bags are used as the initial treatment until the affected climbers can be evacuated to the nearest hospital. Presently, these air pressure bags have been “re-purposed” and incorrectly marketed for use in hyperbaric oxygen therapy. Promoters of air bags have directly targeted the parents and families with children affected by autism and cerebral palsy. Fundamentally, it is not possible to deliver hyperbaric oxygen therapy in these devices. The benefits of actual body tissue repair only result from the increased oxygen saturation in a person’s plasma that is achieved with HBOT. This does not happen below 1.5 atmospheres of pressure (ATA) breathing 100% oxygen. In this issue of the newsletter, we will highlight the main differences between hyperbaric oxygen chamber and air pressure bags.

A portable hyperbaric chamber is an inflatable bag that is filled with normal room or enriched air under pressure to a maximum of 1.3 ATA. The Undersea and Hyperbaric Medical Society defines hyperbaric oxygen treatment as breathing 100% oxygen delivered at pressures greater than 1.4 ATA. Portable hyperbaric bags can reach a maximum of 1.3 ATA and administer only room air. This, by definition, means that these bags do not provide hyperbaric oxygen therapy. Neither do they provide mild HBOT, which is a term used to describe treatments given between 1.5 and 1.75 ATA with 100% oxygen. Any alterations to the bag to provide more oxygen are not approved as safe. Many desperate operators try to increase oxygen levels by adding extra oxygen using oxygen concentrators. However this has a minimal affect on the actual level of oxygen as room air is used to pressure the bag and any added oxygen combines quickly with the air. Great safety concerns result when “home-made” ingenuity plays a role in attempting to deliver medical treatments.

1. Portable hyperbaric bags are FDA approved ONLY for use in treating acute altitude sickness and when air pressure is used. They are NOT FDA approved to be used for any other treatment or in any other way.
2. Some of the safety concerns involving the use of portable bags include:
   • Air Supply
     • As the air intake to the bags is from the environment directly surrounding the bags it is susceptible to contaminated air sources,
   • Fire Safety
     • No grounding system in place to prevent typical electrical charges from starting a fire. This is especially true where operators try to increase oxygen levels in the bags
   • No Operating Safety Standards
     • Air pressure bags are approved for use with a maximum pressure of 1.3 ATA. This is mainly intended to treat acute high altitude sickness. There are some recent reports of portable chamber explosions when they were operated above the approved pressure. Based on these incidents, the FDA has issued warning letters as shown in these links:
       • http://www.hyperbarics.info/1/post/2012/10/fda-reports-second-chamber-explosion-grand-dive-vertical-hyperbaric-chamber-healing-dives-summit-to-sea-hyperbaric-options-sold-known-unsafe-hyperbaric-chamber.html
       • http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm191719.htm
       • http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2682191
3. Many treatment protocols require pressures greater than 1.5 to provide an effective treatment in order to reach a minimum threshold of oxygen delivered. Treating these conditions, regardless of the number of treatments given, without administering this amount of oxygen will not provide results.
4. For hyperbaric oxygen to be effective, it has to reach a plasma saturation of 1000 mmHg which cannot be achieved using the soft chambers by any means, the following graph shows the difference between different chambers:

At the Nardella Clinic, our naturopathic doctors use hyperbaric chambers manufactured by Perry Baromedical. These chambers are approved by the FDA and Canadian authorities to be used for medical purposes. If you have detailed questions about hyperbaric medicine, please contact the clinic by phone or email.