Adenotonsillectomy and Obstructive Sleep Apnea Study

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. Identifier: NCT01462539
Recruitment Status : Completed
First Posted : October 31, 2011
Last Update Posted : November 30, 2012
Information provided by (Responsible Party):
Joseph D. Tobias, Nationwide Children's Hospital

Brief Summary:
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.

Condition or disease

Study Type : Observational
Actual Enrollment : 200 participants
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
Study Start Date : October 2011
Primary Completion Date : August 2012
Study Completion Date : October 2012

OSAS group
Non-OSAS group

Primary Outcome Measures :
  1. Length of stay (LOS) [ Time Frame: 1 Day (Day of Surgery) ]

Secondary Outcome Measures :
  1. Cause of increased Length of stay (LOS) [ Time Frame: 1 Day (Day of Surgery) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
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

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 identifier (NCT number): 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

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
First Posted: October 31, 2011    Key Record Dates
Last Update Posted: November 30, 2012
Last Verified: November 2012