Study to Determine Incidence of Hypoventilation in Patients Who Have Undergone Gastric Bypass
The purpose of this study is to determine if gastric bypass patients experience hypoventilation in the immediate postoperative period, and to what degree.
|Study Design:||Time Perspective: 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|
|Study Start Date:||January 2006|
|Study Completion Date:||October 2009|
|Primary Completion Date:||October 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00316446
|United States, Florida|
|University of South Florida, Department of Surgery at Tampa General Hospital|
|Tampa, Florida, United States, 33606|
|Principal Investigator:||Scott F Gallagher, MD||University of South Florida, Department of Surgery|