Adenotonsillectomy and Obstructive Sleep Apnea Study

This study has been completed.
Information provided by (Responsible Party):
Joseph D. Tobias, Nationwide Children's Hospital Identifier:
First received: October 27, 2011
Last updated: November 29, 2012
Last verified: November 2012
Adenotonsillectomies are one of the most common childhood surgeries and are first-line treatment to correct childhood obstructive sleep apnea syndrome (OSAS). This is a study comparing patients with and without OSA looking at the length of stay following adenotonsillectomy and the factors affecting length of stay.


Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Factors That Increase Length of Stay After Outpatient Surgery of 3-6 Year Olds With OSAS Symptoms Versus Without OSAS Symptoms After Adenotonsillectomy

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

Primary Outcome Measures:
  • Length of stay (LOS) [ Time Frame: 1 Day (Day of Surgery) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cause of increased Length of stay (LOS) [ Time Frame: 1 Day (Day of Surgery) ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: October 2011
Study Completion Date: October 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
OSAS group
Non-OSAS group


Ages Eligible for Study:   3 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing adenotonsillectomy only with no concurrent surgery

Inclusion Criteria:

  1. history of snoring/gasping/ or pause in breathing reported by caregivers.
  2. age 3-6 years old
  3. undergoing adenotonsillectomy only no concurrent surgery
  4. scheduled as outpatient and plan for discharge home

Exclusion Criteria:

  1. Preoperatively requiring additional respiratory support
  2. scheduled for concurrent surgery that could increase total general anesthetic time
  3. recurrent adenotonsillitis as sole indication for surgery
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Please refer to this study by its identifier: NCT01462539

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

No publications provided

Responsible Party: Joseph D. Tobias, Chairman Dept. of Anesthesiology & Pain Medicine, Nationwide Children's Hospital Identifier: NCT01462539     History of Changes
Other Study ID Numbers: IRB11-00364
Study First Received: October 27, 2011
Last Updated: November 29, 2012
Health Authority: United States: Institutional Review Board processed this record on November 25, 2015