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OpenTrials
Completed

NCT Number: NCT00316446

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Tampa, Florida, 33606, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Collaborators

  • Medtronic - MITG

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Apr 20, 2006
Registry last updated
Sep 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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