Study to Determine Incidence of Hypoventilation in Patients Who Have Undergone Gastric Bypass

NCT ID: NCT00316446

Last Updated: 2012-09-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2009-10-31

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 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.

Conditions

Morbid Obesity; Bariatric Surgery

Study Design

• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medtronic - MITG

INDUSTRY

Sponsor Role: collaborator

University of South Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott F Gallagher, MD

Role: PRINCIPAL_INVESTIGATOR

University of South Florida, Department of Surgery

Locations

University of South Florida, Department of Surgery at Tampa General Hospital

Tampa, Florida, United States

Countries

United States

Other Identifiers

USF1

Identifier Type: -

Identifier Source: org_study_id