Clinical Trial – Pseudoephedrine Prophylaxis for Prevention of Middle Ear Barotrauma in Hyperbaric Oxygen Therapy
Hyperbaric oxygen therapy (HBOT) utilizes 100% oxygen delivery at a pressure greater than 1 atm for the treatment of various emergent medical conditions including carbon monoxide poisoning. The most commonly associated complication of HBOT is middle ear barotrauma (MEB) which occurs when the eustachian tube does not allow air to enter the middle ear space to equalize the pressure between the ambient environment and the inner ear. Patients experiencing MEB usually feel pressure or pain in their ear(s). The spectrum of symptoms ranges from sensation of ear fullness and muffled hearing to severe pain, vertigo and tympanic membrane rupture. HBOT has not been studied. The investigators plan to perform a randomized double blind placebo control trial to determine if pseudoephedrine is effective in decreasing the rate of MEB during HBOT.
COVID-19 may cause severe pneumonitis that require ventilatory support in some patients, the ICU mortality is as high as 62%. Hospitals do not have enough ICU beds to handle the demand and to date there is no effective cure. We explore a treatment administered in a randomized clinical trial that could prevent ICU admission and reduce mortality. The overall hypothesis to be evaluated is that HBO reduce mortality, increase hypoxia tolerance and prevent organ failure in patients with COVID19 pneumonitis by attenuating the inflammatory response.
Clinical Trial – Effect of Self-acupressure on Middle Ear Barotrauma Associated With Hyperbaric Oxygen Therapy
Middle ear barotrauma (MEB) is the most common complication during hyperbaric oxygen therapy
(HBOT). Though Valsalva and Toynbee maneuvers have been proposed to prevent MEB, still some
patients discontinue HBOT due to severe otalgia, hemorrhage or perforation of tympanic
membrane associated with HBOT. Currently, there is no optimal prophylactic management for MEB
associated with HBOT. The aim of this protocol is to investigate the efficacy of
self-acupressure therapy on MEB associated with HBOT.
Currently, Hyperbaric Oxigen (HBO) is a widely used treatment for several conditions. There
are 14 indications for HBO, officially recognized by the Undersea and Hyperbaric Medical
Society (UHMS), but research is discovering other interesting applications.
HBO plays an important role in enhancing antioxidant defense mechanisms by increasing radical
oxygen species (ROS) and nitric oxide species (NOS). This controlled oxidative stress has
been shown to stop the vicious circle of inflammation – damage – hypoxia already seen in
several diseases. Increased neoangiogenesis has been demonstrated at pressures of 2
atmospheres absolute (ATA), while effects helping ischemic tissues need pressures between 2.5
and 2.8 ATA to develop.
During sports activities, metabolism generates waste products – mostly CO2, lactic acid, but
also ROS. HBO could be useful in modulating antioxidant mechanisms and helping cells in the
recovery after training and sportive competitions.
The authors hypothesize that:
1. HBO can reduce oxidative stress in healthy professional athletes
2. HBO can ameliorate the lactic acid clearance after a maximal exercise
3. HBO at low pressures (L-HBO at 1.45 ATA) is at least comparable to conventional HBO (at
2.5 ATA) in reducing oxidative stress and ameliorating lactic acid clearance after a
The Authors will include healthy athletes. These will be randomly assigned to a control
group, a L-HBO group, or a HBO group. The Authors will assess oxidative stress changes and
lactic acid clearance (testing it after a maximal exercise) before and after 20 L-HBO/HBO
treatments, and after 2 months after the end of treatments.
Clinical Trial – Hyperbaric Oxygen Therapy Compared to Pharmaceutical in Fibromyalgia With Emotional Trauma
The investigators have previously studied the efficacy of hyperbaric oxygen therapy (HBOT) as
a treatment for Fibromyalgia syndrome (FMS) in a prospective, active control, crossover
clinical trial. The results demonstrated significant amelioration of all FMS symptoms, with
significant improvement in life quality; furthermore, the investigators were able to
demonstrate significant neuroplasticity on SPECT imaging, with a decrease of the
hyperactivity in posterior regions and elevation of the reduced activity in frontal areas.
In this study, the investigators intend to both repeat and expand the investigator’s previous
findings, treating FMS patients with history of emotional trauma with HBOT, while performing
an extensive of evaluation both before and after treatment.
In the current study, the investigators plan to compare HBOT to current standard of care of
FMS (pharmacological and non – pharmacological).