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| Sponsors and Collaborators: |
University of South Florida Nellcor |
|---|---|
| Information provided by: | University of South Florida |
| ClinicalTrials.gov Identifier: | NCT00316446 |
Purpose
The purpose of this study is to determine if gastric bypass patients experience hypoventilation in the immediate postoperative period, and to what degree.
| Condition |
|---|
|
Morbid Obesity Bariatric Surgery |
| Study Type: | Observational |
| Study Design: | Prospective |
| Official Title: | A Prospective Double Blind Pilot Study to Determine the Incidence of Postoperative Hypoventilation in Patients With Clinically Significant Obesity Who Have Undergone Gastric Bypass Procedures Under General Anesthesia |
| Estimated Enrollment: | 20 |
| Study Start Date: | January 2006 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
The study population will include male and female adult patients (age 18-65) with clinically significant obesity (body mass index (BMI) between 40-85 kg/m2), who are approved for gastric bypass surgery for weight loss. Patients must have documented obstructive sleep apnea and use continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP), and have an American Society of Anesthesiologists (ASA) Physical Status Classification I-III.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Tracy A Torrella, MA | 813-844-8454 | ttorrell@health.usf.edu |
| United States, Florida | |
| University of South Florida, Department of Surgery at Tampa General Hospital | Recruiting |
| Tampa, Florida, United States, 33606 | |
| Contact: Tracy A Torrella, MA 813-844-8454 ttorrell@health.usf.edu | |
| Principal Investigator: Scott F Gallagher, MD, FACS | |
| Sub-Investigator: Lynnette G Osterlund, MD | |
| Sub-Investigator: Michel Murr, MD, FACS | |
| Principal Investigator: | Scott F Gallagher, MD | University of South Florida, Department of Surgery |
More Information
| Responsible Party: | University of South Florida ( Scott Gallagher, MD, FACS, Principal Investigator ) |
| Study ID Numbers: | USF1 |
| Study First Received: | April 18, 2006 |
| Last Updated: | December 20, 2007 |
| ClinicalTrials.gov Identifier: | NCT00316446 |
| Health Authority: | United States: Institutional Review Board |
|
Body Weight Signs and Symptoms Obesity Respiratory Insufficiency Respiratory Tract Diseases Respiration Disorders |
Hypoventilation Signs and Symptoms, Respiratory Nutrition Disorders Overweight Overnutrition Obesity, Morbid |
