Veterans Special Report

Clinical Trial – Efficacy Study of Riociguat and Its Effects on Exercise Performance and Pulmonary Artery Pressure at High Altitude

by | Dec 18, 2013 | Clinical Trials, HBOT Research, Hypertension, Pulmonary

During ascent to high altitude there is a physiologic response to hypoxia that results in an
elevated pulmonary arterial pressure associated with decreased exercise performance,
altitude-induced pulmonary hypertension, and high altitude pulmonary edema (HAPE). Riociguat
is a novel agent from Bayer Pharmaceuticals that has already demonstrated effectiveness in
the treatment of pulmonary hypertension, and it may prove to be beneficial in cases of
altitude-induced pulmonary hypertension or HAPE. This research study, composed of 20 healthy
volunteers ages 18-40 years, will attempt to mimic the decreased oxygen supply and elevated
pulmonary artery pressures found in conditions of high altitude, allowing observation of the
effects of riociguat and exercise on pulmonary arterial pressure, arterial oxygenation, and
exercise performance. Prior to entering the hypobaric chamber, subjects will have radial
arterial lines and pulmonary artery catheters placed to obtain arterial and pulmonary artery
pressure measurements. Subjects will then enter the hypobaric chamber and perform exercise
tolerance tests at a simulated altitude of 15,000 feet on an electrically braked ergometer
(exercise bike) before and after administration of riociguat. If, after administration of
riociguat and exposure to a simulated altitude of 15,000 feet, the exercise performance is
improved and observed pulmonary artery pressures are lower than those measurements seen prior
to administration of riociguat, this could lead to development of a prophylactic and/or
treatment strategy for HAPE and high-altitude pulmonary hypertension. Statistical analysis
will compare the variables of pulmonary artery pressure, radial arterial pressure,
ventilation rate, cardiac output, PaO2, and work rate at exhaustion before and after
administration of the drug riociguat. The investigator’s hypothesis is that riociguat will
decrease pulmonary artery pressure and improve gas exchange and exercise performance at
altitude.

Clinical Trial – Hyperbaric Bupivacaine and Hyperbaric Levobupivacaine in C/S

by | Dec 12, 2013 | Clinical Trials, HBOT Research, Health Care

Aim of the Study To compare the effects of hyperbaric bupivacaine plus fentanyl with
hyperbaric levobupivacaine plus fentanyl on spinal block quality, haemodynamics and need for
analgesics in patients undergoing elective cesarean section. Our hypothesis is that
hyperbaric levobupivacaine will provide equal block quality, but better haemodynamic
conditions compared to hyperbaric bupivacaine.

Clinical Trial – Hemodynamic Effects of Low Dose Spinal Anesthesia for Cesarean Section

by | Sep 26, 2013 | Clinical Trials, Complications; Cesarean Section, HBOT Research

We propose to study the effects on hemodynamics (blood pressure, cardiac output, and central
venous pressure) of two doses of bupivacaine for spinal anesthesia during cesarean section: a
higher dose of 12 mg to a lower dose of 4.5 mg. We will examine recovery times, incidence of
hypotension, and compare pain control and maternal satisfaction during and after cesarean
section.

We hypothesize that low dose bupivacaine spinal anesthesia will provide equivalent anesthesia
for cesarean section compared to conventional dose bupivacaine, with less hypotension, faster
recovery time, and enhanced maternal satisfaction. Maternal satisfaction will be assessed by
self-reported pain scores, incidence of nausea and vomiting, shivering, and ability to
interact with baby in the OR.