Clinical Trials

Clinical Trial – Hyperbaric Oxygenation in Athletes: Standard Versus Low Pressure

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
maximal exercise.

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).

Clinical Trial – The Effects of Ilioinguinal Nerve Block on Chronic Pain in Patients in Inguinal Hernia With Spinal Anesthesia

Regional anesthesia is a popular anesthetic method in patients who will undergo an inguinal
hernia operation. Researchers known that pain in the operating area is a complaint that
impairs the quality of life for patients in the long term after the operation. In addition to
regional anesthesia, has planned to investigate the effects of applying another drug near the
surgery area on pain that may develop in the long term.

Clinical Trial – Cognitive Profile of Patients at the Sagol Center for Hyperbaric Medicine and Research

In the investigator’s institute there is ongoing treatment of different patients with
cognitive deficits using Hyperbaric oxygen therapy (HBOT). These patients undergo
neuro-cognitive function computerized tests before and after treatment.

The aim of this study was to retrospectively evaluate the cognitive changes before and after
HBOT in different patients populations.

Clinical Trial – Postoperative Urinary Retention in Orthopedic Patients

The objective of this study is to compare the incidence of postoperative urinary retention
related to spinal anesthesia with morphine and spinal anesthesia associated with peripheral
blockade in orthopedic procedures of lower limbs. Secondary objectives are assessing the
incidence of nausea and vomiting; postoperative pain and opioid consumption at 24 hours after
surgery with each of the techniques. A total of 52 patients submitted to a lower limb
orthopedic procedure were randomized to the intervention groups: spinal anesthesia with
morphine versus spinal anesthesia without opioid associated with peripheral nerve block.
After surgery, bladder ultrasound will be performed in post-anesthesia care unit to identify
urinary retention and patients will be followed for 24 hours to assess outcomes.

Clinical Trial – Autonomic Modulation After Spinal Anesthesia With Depth of Anesthesia and Vital Signs.

Spinal anaesthesia has the advantage that produced nerve block by the injection of local
anaesthetic into cerebrospinal fluid (CSF). However, the greatest challenge in spinal
anaesthesia is to control the spread of local anaesthetic through the CSF to provide a block
which is adequate for the proposed surgery without unnecessary extensive spread, and
increased risk of complications.

Clinical Trial – Measuring Cognitive Enhancement During Hyperbaric Oxygen Treatments

The aim of the current study was to examine the effect of short-term HBOT (hyperbaric oxygen
treatments) on a range of cognitive abilities. The current study examined whether there is a
HBOT-related short-term cognitive improvement and, if so, what specific cognitive abilities
are improved by the intervention.

Participants were randomized to perform cognitive tasks in one of two chambers with two
different clinical environments: (a) HBOT condition: (2 ATA (atmosphere absolute) 100% oxygen
for 90 minutes). (b) Control condition: in which the chamber was not pressurized (Normobaric
condition- 1 ATA for 90 minutes).

Clinical Trial – Effects of HBO on Patients With DM

The purpose of this Research Study is:

1. To determine the reliability and performance of the Dexcom G6® continuous glucose
monitoring (CGM) system in patients with diabetes undergoing hyperbaric oxygen (HBO2)
exposure. The study-specific blood glucose meter and CGM system are approved by the FDA
(U.S. Food and Drug Administration).

2. To determine whether HBO2 exposure causes blood glucose to drop as a result of the
treatment.

3. To determine whether HBO2 causes a change in blood glucagon (a hormone that raises blood
glucose).

Investigators will be comparing changes in blood glucose and glucagon in volunteers with
diabetes who will be exposed to a single hyperbaric oxygen treatment (pressurization to 2.4
atmospheres absolute for 90 minutes) to a control period of 2 hours where volunteers will
simulate a hyperbaric treatment while sitting in an examination room breathing room air at
sea level pressure. Investigators will be measuring blood glucose with a variety of devices
including a continuous glucose monitor, two point-of-care glucometers, and the hospital
inpatient laboratory measurement of venous blood.

Clinical Trial – the Use of Magnesium Sulfate for Prevention of Postspinal Shivering

Shivering is an unpleasant experience after spinal anesthesia. Shivering is defined as an
involuntary, repetitive activity of skeletal muscles. The mechanisms of shivering in patients
undergoing surgery are mainly intraoperative heat loss, increased sympathetic tone, pain, and
systemic release of pyrogens. Spinal anesthesia significantly impairs the thermoregulation
system by inhibiting tonic vasoconstriction, which plays a significant role in temperature
regulation. Spinal anesthesia also causes redistribution of core heat from the trunk (below
the block level) to the peripheral tissues. These two effects predispose patients to
hypothermia and shivering. The median incidence of shivering related to regional anesthesia
observed in a review of 21 studies is 55%. Shivering increases oxygen consumption, lactic
acidosis, carbon dioxide production, and metabolic rate by up to 400%. Therefore, shivering
may cause problems in patients with low cardiac and pulmonary reserves. The best way to avoid
these intraoperative and postoperative shivering-induced increases in hemodynamic and
metabolic demands is to prevent shivering in the first place. Although magnesium is among
several pharmacological agents used for the treatment of shivering, its effects on prevention
of shivering during central neuraxial blockade have not been evaluated to date. Henceforth,
the aim of this study was to evaluate the effect of magnesiume on shivering during spinal
anesthesia.

Aim:

to compare the efficacy of intravenous versus intrathecal magnesium sulphate for prevention
of post spinal shivering in adult patients undergoing elective lower limb orthopedic
surgeries.