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Adenotonsillectomy and Obstructive Sleep Apnea Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01462539
First Posted: October 31, 2011
Last Update Posted: November 30, 2012
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):
Joseph D. Tobias, Nationwide Children's Hospital
  Purpose
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
Adenotonsillectomy

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 Joseph D. Tobias, Nationwide Children's Hospital:

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

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

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)
Groups/Cohorts
OSAS group
Non-OSAS group

  Eligibility

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
Criteria

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
  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): NCT01462539


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 Childrens Hospital
  More Information

Responsible Party: Joseph D. Tobias, Chairman Dept. of Anesthesiology & Pain Medicine, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01462539     History of Changes
Other Study ID Numbers: IRB11-00364
First Submitted: October 27, 2011
First Posted: October 31, 2011
Last Update Posted: November 30, 2012
Last Verified: November 2012