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

Morbid Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00316446
• Other study ID #: USF1
• Status: Completed
• Phase: N/A
• First received: April 18, 2006
• Last updated: September 18, 2012
• Start date: January 2006
• Est. completion date: October 2009

Study information

• Verified date: September 2012
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine if gastric bypass patients experience hypoventilation in the immediate postoperative period, and to what degree.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Bariatric Surgery
• Hypoventilation
• Morbid Obesity
• Obesity, Morbid

Locations

Country	Name	City	State
United States	University of South Florida, Department of Surgery at Tampa General Hospital	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of South Florida	Medtronic - MITG

Country where clinical trial is conducted

United States,