Study to Determine Incidence of Hypoventilation in Patients Who Have Undergone Gastric Bypass - NCT00316446-33606 (Clinical Trial 140981)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy140981.aspx
|
** Please review additional "Nearby Studies" on right ----->
|
|
 |
 |
|
| City: |
|
Tampa |
|
State:
|
|
FL |
| Zip Code: |
|
33606 |
| Conditions: |
|
Morbid Obesity - Bariatric Surgery |
| Purpose: |
|
The purpose of this study is to determine if gastric bypass patients experience
hypoventilation in the immediate postoperative period, and to what degree.
|
| Study summary: |
|
We propose to determine if patients with clinically significant obesity (body mass index,
BMI, between 40 kg/m2 and 85 kg/m2), who have undergone gastric bypass procedures under
general anesthesia hypoventilate during the initial twenty-four hour postoperative period,
and if so, to what degree. Adequacy of ventilation will be assessed by serial arterial
blood analyses. Patients will be monitored for SpO2 in the preoperative holding area, in
the operating room, and the post-anesthesia care unit (PACU) by conventional and study pulse
oximeters. SpO2 data will be collected continuously and recorded on the study pulse oximeter
for the entire study period. Arterial blood samples will be drawn for analysis every four
hours by in-dwelling arterial catheter, using standard sterile technique. Hypoventilation is
defined as an increase in PaCO2 five or more mm Hg above patient's baseline. |
| Criteria: |
|
Inclusion Criteria:
- Male and female subjects 18 to 65 years of age
- Clinically significant obesity with a BMI between 40 and 85
- Candidates approved for gastric bypass surgery at Tampa General Hospital (*Please
note: authorization for gastric bypass will be completed prior to enrollment in
study; this study does not pay for the cost of the operation.)
- American Society of Anesthesiologists (ASA) Physical Status Classification I-III
- Able to understand and sign informed consent
Exclusion Criteria:
- Patients not able to understand the informed consent process, or unable to understand
the research protocol
- Patients in which placing an arterial catheter would pose a clinically unacceptable
health risk, e.g., bleeding disorders, radial artery malformation |
|
|
|
| Study is available at: |
|
University of South Florida, Department of Surgery at Tampa General Hospital
Tampa, FL 33606
United States
Primary Contact:
Tracy A Torrella, MA
Email: ttorrell@health.usf.edu
Phone: 813-844-8454
Secondary Contact:
Tracy A Torrella, MA
Email: ttorrell@health.usf.edu
Phone: 813-844-8454 |
|
|
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
|
| Trials Alerts: |
|
If you would like to be
notified of new clinical trials as they become available please
register for a free account.
|
|
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
February 15, 2010 |
Modifications to
this listing: |
|
Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
|
|
|
|
|