A trial to see if an external device (ABSHELL) can reduce the pressure in the abdomen in patients who are obese. Obesity has become an extremely great problem in the United States. In the severely obese, the high pressure inside the abdomen can cause increase in pressure inside the veins draining the kidneys, as well as pushing up the diaphragm. This squeezes the lungs and heart, which leads to shortness of breath and the need to retain salt and water. The new device called ABSHELL generates a negative pressure around the abdomen, which should lower the increased intra-abdominal pressure associated with obesity. This device may improve several medical problems associated with obesity. Visits to the CRC will be for two weeks. On the first and second days, baseline blood pressure, blood and urine tests will be done. On the second day, a catheter will be inserted into the bladder to measure bladder pressure and for urine collection. The catheter will remain in for four days. Patients will be randomly assigned to a group that uses the device or to a group that has no treatment.This will help to determine if rest alone in a non-stressful environment is as effective as the use of the device to lower blood pressure. Those using the ABSHELL device will have it placed outside of the abdomen. A vacuum is applied to the shell, pulling up the abdomen and lowering the pressure inside the area. However, since the ABSHELL is also pulled into the abdomen, and may feel uncomfortable, a counteraction device is then applied which pulls the shell up. This relieves the discomfort and lowers the pressure inside the abdomen even more. Those randomized to use the device will have bladder pressure decreased until it reaches a level seen in non-obese individuals. It will be worn on days 2,4,5,and 6 from 8:00a.m. to noon, and from 1:00 to 5:00p.m. On nights 7 through 11, the device will be worn from 10:00 to 8:00 a.m. when the patient is asleep. Blood will be drawn during the visit. Blood pressure and pulse rate will be measured frequently and the negative pressure will be reduced or released if severe discomfort or a marked fall in blood pressure develops. The blood thinner heparin will be given to prevent blood clots forming in the legs over a long period of bed rest. An ultrasound will be done to evaluate the large blood vessels in the neck and legs and to measure the rate of blood flow. During the second week of the study, patients will wear the ABSHELL at night. They will feel more comfortable, less bloated, and will be able to breathe more easily.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000065-38
Application #
6419297
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
1977-12-01
Project End
2002-11-30
Budget Start
Budget End
Support Year
38
Fiscal Year
2000
Total Cost
Indirect Cost
Name
Virginia Commonwealth University
Department
Type
DUNS #
City
Richmond
State
VA
Country
United States
Zip Code
23298
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