NCT01655238

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,327

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2012

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

July 1, 2012

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 1, 2012

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 8, 2016

Status Verified

January 1, 2016

Enrollment Period

3.4 years

First QC Date

July 30, 2012

Last Update Submit

January 7, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Length of stay

    1 week

Secondary Outcomes (1)

  • Number of subjects with respiratory complications

    1 week

Study Arms (3)

95-99% BMI ASC

Patients having a BMI between 95-99% who are seen in the ambulatory surgery centers.

Other: BMI

95-99% BMI NCH main OR

Patients having a BMI between 95-99% who are seen in the main operating rooms.

Other: BMI

>99% BMI NCH main OR

Patients having a BMI \>99% who are seen in the main operating rooms.

Other: BMI

Interventions

BMIOTHER

Screening guideline to assess body mass index.

95-99% BMI ASC95-99% BMI NCH main OR>99% BMI NCH main OR

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Obese patients

You may qualify if:

  • Patients 95% or over BMI having outpatient surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (2)

  • 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.

    PMID: 12519133BACKGROUND
  • 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.

    PMID: 17474948BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Vidya Raman, MD

    Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Preoperative Assessment Testing

Study Record Dates

First Submitted

July 30, 2012

First Posted

August 1, 2012

Study Start

July 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 8, 2016

Record last verified: 2016-01

Locations