Status:
COMPLETED
Study to Determine Incidence of Hypoventilation in Patients Who Have Undergone Gastric Bypass
Lead Sponsor:
University of South Florida
Collaborating Sponsors:
Medtronic - MITG
Conditions:
Morbid Obesity
Bariatric Surgery
Eligibility:
All Genders
18-65 years
Brief Summary
The purpose of this study is to determine if gastric bypass patients experience hypoventilation in the immediate postoperative period, and to what degree.
Detailed Description
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 hyp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00316446
Start Date
January 1 2006
End Date
October 1 2009
Last Update
September 20 2012
Active Locations (1)
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1
University of South Florida, Department of Surgery at Tampa General Hospital
Tampa, Florida, United States, 33606