- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01655238
Obesity Guidelines for Outpatient Surgery
January 7, 2016 updated by: Vidya Raman, Nationwide Children's Hospital
Have NCH Obesity Guidelines Made an Impact? Differences in Anesthetizing the Obese Child in Outpatient Sites Versus Main OR at NCH.
The investigators are concerned about anesthetizing obese children in outpatient locations in case they need prolonged stay, increased respiratory interventions, or need for post-operative narcotics.
The investigators will be using a screening guideline to help us determine the higher risk child based on BMI and co-morbid conditions.
The investigators will also be doing a retrospective chart review of 300 patients with BMI 95% and looking at various factors during the operative and post-operative period.
Study Overview
Study Type
Observational
Enrollment (Actual)
1327
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43205
- Nationwide Children's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Obese patients
Description
Inclusion Criteria:
- Patients 95% or over BMI having outpatient surgery.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
95-99% BMI ASC
Patients having a BMI between 95-99% who are seen in the ambulatory surgery centers.
|
Screening guideline to assess body mass index.
|
|
95-99% BMI NCH main OR
Patients having a BMI between 95-99% who are seen in the main operating rooms.
|
Screening guideline to assess body mass index.
|
|
>99% BMI NCH main OR
Patients having a BMI >99% who are seen in the main operating rooms.
|
Screening guideline to assess body mass index.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Length of stay
Time Frame: 1 week
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of subjects with respiratory complications
Time Frame: 1 week
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Smith HL, Meldrum DJ, Brennan LJ. Childhood obesity: a challenge for the anaesthetist? Paediatr Anaesth. 2002 Nov;12(9):750-61. doi: 10.1046/j.1460-9592.2002.00781.x.
- Nafiu OO, Reynolds PI, Bamgbade OA, Tremper KK, Welch K, Kasa-Vubu JZ. Childhood body mass index and perioperative complications. Paediatr Anaesth. 2007 May;17(5):426-30. doi: 10.1111/j.1460-9592.2006.02140.x.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2012
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
July 30, 2012
First Submitted That Met QC Criteria
July 31, 2012
First Posted (Estimate)
August 1, 2012
Study Record Updates
Last Update Posted (Estimate)
January 8, 2016
Last Update Submitted That Met QC Criteria
January 7, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB12-00324
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.