NCT00316446

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 20, 2006

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

September 20, 2012

Status Verified

September 1, 2012

Enrollment Period

3.8 years

First QC Date

April 18, 2006

Last Update Submit

September 18, 2012

Conditions

Morbid ObesityBariatric Surgery

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Tampa, Florida, 33606, United States

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Scott F Gallagher, MD

    University of South Florida, Department of Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2006

First Posted

April 20, 2006

Study Start

January 1, 2006

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

September 20, 2012

Record last verified: 2012-09

Locations

US(1)