Clinical Trials

Clinical Trial – Insulin Sensitivity During Hyperbaric Oxygen Compared to Hyperbaric Air

In a recent series of studies performed by our group, we have shown that exposure to
hyperbaric oxygen (HBO) leads to an increase in insulin sensitivity in male subjects with
type-2 diabetes (T2DM) and in obese and overweight men without diabetes. The aim of this
study is to investigate the relationship between pressure and oxygen in producing this
effect, specifically, is this effect measurable in hyperbaric air or is some higher pressure
of oxygen required?

Aims:

1. To determine whether the insulin sensitising effect of HBO is apparent in hyperbaric air
at the same pressure as HBO.

2. To examine mechanisms underpinning the increase in insulin sensitivity following HBO.

Clinical Trial – GA/Spinal vs. GA/Spinal/NMB for Operative Repair of Hip Fracture

Surgical repair of hip fractures may be performed with various anesthetic techniques, but are
most commonly completed under general anesthesia (GA) or neuraxial anesthesia (NA). Numerous
prospective and retrospective studies demonstrate improved morbidity and mortality when NA is
used; however, many surgeons prefer the use of GA with neuromuscular blockade (NMB) due to
the perception of better operative conditions. This study aims to compare the operative
conditions obtained from the use of combined GA and spinal with NMB vs. the use of GA with
spinal without NMB. 84 patients will all receive a single shot spinal and GA and then will be
randomized to receive either NMB or placebo. The fracture reduction time will be measured.

Clinical Trial – Prognosis and Treatment of Necrotizing Soft Tissue Infections: A Prospective Cohort Study

The investigators will analyze biomarkers related to the prognosis and treatment of
necrotizing soft tissue infections (NSTI). The focus will be on whether certain endothelial
and immune system biomarkers can function as markers of disease severity, mortality as well
as the effects of hyperbaric oxygen therapy (HBOT). Biomarkers will be measured upon
admission to an intensive care unit at Copenhagen University Hospital and during the
following 3 days.

Clinical Trial – Oxygen as a Limiting Factor for Performing Multitasking

The Brain uses 20% of the total oxygen supply consumed by the entire body. Even though, less
than 10% of the brain is active at every given time, the brain utilizes almost all the oxygen
delivered. In order to perform different tasks or more than one task (multi-tasking), the
oxygen supply is shifted from one brain region to another, via modulation of blood perfusion.

The aim of the present study was to evaluate whether hyperbaric oxygen (HBO) environment,
with increased oxygen supply to the brain, will enable better performance of complex and/or
multiple activities.

Methods: a prospective, double blind randomized control, cross over trial including healthy
volunteers. Participants were asked to perform a cognitive task, a motor task and a
simultaneous cognitive-motor task (multi-tasking). Participants were randomized to perform
the tasks at 2 environments: (a) normobaric air (1ATA 21% oxygen) (b) HBO (2ATA 100% oxygen).
Two weeks later participants were crossed to the alternative environment. Blinding of the
normobaric environment was achieved in the same chamber with masks on while hyperbaric
sensation was simulated by increasing pressure in the first minute and gradually decreasing
to normobaric environment prior to tasks performance.

Clinical Trial – Hyperbaric Oxygen and Orthopedic Comprehensive Treatment for Traumatic Incomplete Spinal Cord Injury in the Plateau

To observe modified Barthel index, American Spinal Injury Association (ASIA) impairment scale
grading, sensory score and motor score in patients with incomplete SCI in the plateau using
0.2 MPa HBO combined with pedicle screw fixation and decompressive laminectomy so as to
investigate the effect of HBO therapy on incomplete SCI in the plateau.

Clinical Trial – The Effects of Different Anesthetic Techniques on QT, Corrected QT (QTc), and P Wave Dispersions in Cesarean Section

This study evaluates the effects of different anesthetic techniques on QT, QTc, and Pwd in
cesarean section. Half of participants received general anesthesia, while the other half
received spinal anesthesia Electrocardiography (ECG) recordings were performed at
preoperative, 5, 15, 30 min after initiation anesthesia and 30 min post-operatively.
Hemodynamic state were also recorded at the same time intervals. QT, corrected QT (QTc), QT
dispersion (QTd), QTc dispersion (QTcd), P-wave dispersion (Pwd), corrected JT interval, T
wave (Tp-e), transmular dispersion of repolarization durations were measured from ECG records
at predetermined time intervals of spinal or general anesthesia.

Clinical Trial – Hyperbaric Oxygenation (HBO) in Traumatic Spinal Cord Injury. (EOS) – Pilot Study

Hypothesis of the Study:

Based on the presented results, the investigator hypothesises that HBO preserves neurons that
are not irreversibly damaged (i.e. severed) during initial trauma, thus enabling regain of
their function. The investigator predicts that HBO treatment protects and enhances motor
function in initially paralysed regions, including improvement in function of the extremities
as well as recovery of urinary bladder control and bowel function.

Outline of the Proposed Study:

Within a prospective "proof of principle" trial, a total of 100 patients will be included.
Fifty patients will be recruited at the Division of Thoracic and Hyperbaric Surgery, Medical
University of Graz. In parallel, 50 control patients will be included at the Department of
Orthopaedics and Trauma, Paracelsus University Salzburg, Salzburger Landeskliniken (SALK),
Austria. Thereby, all patients that are admitted at the Medical University of Graz can be
treated and the enrolment of 50 patients into the treatment group can be implemented within
the outlined time frame. The active recruitment period is planned for three years. Both HBO
treated and control patients will undergo the same surgical and nonsurgical procedures. HBO
treatment will be started within 24 hours after the injury. A total of 21 consecutive daily
sessions will be applied, followed by routine rehabilitation programmes. By matching control
and HBO-treated patients, an evaluation of the treatment effect of HBO is possible. The
outcome will be evaluated by implementing the American Spinal Injury Association
(ASIA)-scores and magnet resonance (MR) imaging. Additionally, inflammatory and regenerative
blood markers will be analysed (neuroendocrine markers/neuro-transmitters: S100beta, Brain
Derived Neurotrophic Growth Factor [BDNF], Glial Fibrillary Acidic Protein [GFAP], Reactive
Oxygen Species (ROS), norepinephrine; array of pro- and anti-inflammatory cytokines and
chemokines).

Clinical Trial – Thermal Radiofrequency Versus Neurolytic Saddle Rhizotomyfor Severe Pereneal Cancer Pain

The control of perineal malignant pain is difficult and challenging for pain physicians.
Different modalities have been tried to treat this complex pain syndrome including
pharmacotherapy and interventional therapy.

Neuroaxial phenol rhizolysis is simple and cheap option. However; for patients with pelvic or
rectal neoplasms and intact bowel and bladder sphincteric functions, there are neurosurgical
recomendations of selective sacral nerve roots rhizotomy blockade "as an alternative to
chemical saddle rhizotomy".

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