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Obesity Guidelines for Outpatient Surgery

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Vidya Raman, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01655238
First received: July 30, 2012
Last updated: August 26, 2014
Last verified: August 2014
  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.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Length of stay [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of subjects with respiratory complications [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: July 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: September 2014 (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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: July 30, 2012
Last Updated: August 26, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 25, 2014