Clinical Trials

Clinical Trial – A Study Comparing Two Spinal Techniques for for Cesarean Delivery Anesthesia

The purpose of this study is to compare single shot versus sequential bolus spinal technique
via a catheter in patients undergoing Cesarean Section. We aim to determine which technique
results in less blood pressure reduction and subsequent vasopressor use.

Other study endpoints include the incidence of maternal post dural puncture headaches and
nausea and vomiting. In addition blood and CSF will be collected to see if biochemical
mediators are related to wound hyperalgesia and healing.

Clinical Trial – Hyperbaric Hyperoxygenation With Radiotherapy and Temozolomide in Adults With Newly Diagnosed Glioblastoma

Standard treatment for glioblastomas includes radiation and chemotherapy with a drug called
temozolomide (Temodar); however, glioblastomas frequently develop resistance to standard
treatment and recur or progress. Glioblastomas are known to have decreased levels of oxygen
compared to normal tissues. There is evidence that these lower oxygen levels in glioblastomas
may contribute to their ability to resist treatment effects of radiation and chemotherapy. In
this study we will look to increase the oxygen concentration within the glioblastoma by
adding hyperbaric treatments (the experimental part of this study) to standard treatment with
radiation and temozolomide in order to see whether increasing the oxygen concentration within
the tumor increases the tumor-killing ability of standard radiation and chemotherapy.

In addition, the investigators are interested to evaluate the effect of this treatment
protocol on a person’s quality of life and level of stress, and, therefore, the investigators
will ask subjects to complete several brief questionnaires while they are on-study.

Clinical Trial – Atropine to Prevent Nausea and Vomiting After Spinal Anesthesia for Caesarean Section

The aim of this study is to assess the efficacy of atropine in preventing nausea and vomiting
after spinal anesthesia with local anesthetic and morphine for elective Caesarean section.

Patients enrolling in the study will be assigned to one of three groups. One will receive a
small dose of intrathecal atropine; another will receive small-dose intravenous atropine; the
third group will receive placebo.

Clinical Trial – Flexitouch Treatment for Venous Ulcers

This is a study to compare the healing process of venous stasis ulcers when the Flexitouch®
system is added to the standard treatment of venous ulcers. We hypothesize that adding the
Flexitouch® system to standard venous ulcer treatment will result in

1. greater complete healing

2. greater percentage reduction in ulcer area

3. reduced time to complete healing, as compared to the use of standard treatment alone

4. a greater reduction in affected leg volume as compared to standard treatment alone.

Clinical Trial – Carbon Monoxide Monitoring and Emergency Treatment

Carbon monoxide (CO) has been called a "silent killer", and those patients who survive CO
poisoning are at risk of neurological damage, which may be permanent. CO is a leading cause
of unintentional poisoning deaths in the United States, and the odorless gas results in an
estimated average of 20,636 emergency department (ED) visits each year. Oxygen is the
antidote for CO poisoning, and it acts both by attenuating toxic effects and enhancing
elimination. A fractional inspired concentration of oxygen (FiO2) of 0.7 to 0.9 may be
achieved by administration of 100% oxygen delivered using a reservoir with a facemask that
prevents rebreathing. Hyperbaric oxygen therapy may provide added benefit for patients with
CO poisoning, but this therapy is unavailable in many parts of the United States including
Vermont. Use of a continuous positive airway pressure (CPAP) mask may achieve an FiO2 of 1.0,
but the effects of delivering an FiO2 of 1.0 compared to 0.7 in CO poisoning are unknown.
CPAP, by comparison, is inexpensive, portable, and available in most EDs. In this study, the
investigators are testing the hypothesis that oxygen delivered by CPAP will improve both CO
washout kinetics and functional outcomes, compared to the standard therapy of oxygen
delivered by non-rebreathing facemask. Specific Aim 1 will provide toxicokinetic data to
support a potential benefit in the use of CPAP for CO poisoning, by comparing CO elimination
kinetics in response to oxygen therapy delivered by non-rebreathing facemask versus CPAP. The
20 patients expected in our first year will provide adequate power to detect a 20% fall in
half-time of CO elimination. While CPAP may increase CO washout rates, as predicted in
Specific Aim 1, demonstration of real functional benefit will be tested in Specific Aim 2.
This Aim seeks to determine functional (neuropsychological) outcomes in patients with CO
poisoning treated with oxygen therapy delivered by non-rebreathing facemask versus CPAP. Data
showing a therapeutic benefit from CPAP in CO poisoning would have clinical implications.
Compared to hyperbaric oxygen therapy, CPAP therapy can begin earlier, including the
pre-hospital setting, for patients with known exposure. With the frequent nature of CO
poisoning and the widespread availability of CPAP, a potential benefit could lead to improved
outcomes for the 20,000+ patients who present to EDs annually.

Clinical Trial – Hyperbaric Oxygen Therapy in Chronic Stable Brain Injury

The purpose of this study is to discover the feasibility of conducting clinical research in
individuals with chronic sequelae following brain injury who are given hyperbaric oxygen.
This study will also look at the outcome of individuals with a chronic stable brain injury
due to trauma, anoxia (lack of oxygen to the brain), or stroke, who are given hyperbaric
oxygen. Outcome measures testing cognitive (memory, etc.) and functional (balance, strength,
etc.) measures will be performed before the hyperbaric sessions, immediately following them,
and 6 months later. The subject will receive 60 hyperbaric sessions, 60 minutes in the
chamber, to a pressure of 1.5 ATA, once daily, Monday through Friday.

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