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Obesity Guidelines for Outpatient Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01655238
First Posted: August 1, 2012
Last Update Posted: January 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Vidya Raman, Nationwide Children's Hospital
  Purpose
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.

Condition Intervention
Obesity Other: BMI

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Have NCH Obesity Guidelines Made an Impact? Differences in Anesthetizing the Obese Child in Outpatient Sites Versus Main OR at NCH.

Further study details as provided by Vidya Raman, Nationwide Children's Hospital:

Primary Outcome Measures:
  • Length of stay [ Time Frame: 1 week ]

Secondary Outcome Measures:
  • Number of subjects with respiratory complications [ Time Frame: 1 week ]

Enrollment: 1327
Study Start Date: July 2012
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
95-99% BMI ASC
Patients having a BMI between 95-99% who are seen in the ambulatory surgery centers.
Other: BMI
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.
Other: BMI
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.
Other: BMI
Screening guideline to assess body mass index.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Obese patients
Criteria

Inclusion Criteria:

  • Patients 95% or over BMI having outpatient surgery.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01655238


Locations
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
Investigators
Principal Investigator: Vidya Raman, MD Nationwide Children's Hospital
  More Information

Publications:
Responsible Party: Vidya Raman, Director of Preoperative Assessment Testing, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01655238     History of Changes
Other Study ID Numbers: IRB12-00324
First Submitted: July 30, 2012
First Posted: August 1, 2012
Last Update Posted: January 8, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms