Adenotonsillectomy and Obstructive Sleep Apnea Study
This study has been completed.
Information provided by (Responsible Party):
Joseph D. Tobias, Nationwide Children's Hospital
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.
||Observational Model: Cohort
Time Perspective: Prospective
||Factors That Increase Length of Stay After Outpatient Surgery of 3-6 Year Olds With OSAS Symptoms Versus Without OSAS Symptoms After Adenotonsillectomy
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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||August 2012 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||3 Years to 6 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients undergoing adenotonsillectomy only with no concurrent surgery
- history of snoring/gasping/ or pause in breathing reported by caregivers.
- age 3-6 years old
- undergoing adenotonsillectomy only no concurrent surgery
- scheduled as outpatient and plan for discharge home
- Preoperatively requiring additional respiratory support
- scheduled for concurrent surgery that could increase total general anesthetic time
- recurrent adenotonsillitis as sole indication for surgery
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01462539
|Nationwide Children's Hospital
|Columbus, Ohio, United States, 43205 |
Nationwide Children's Hospital
||Vidya Raman, MD
||Nationwide Childrens Hospital
No publications provided
ClinicalTrials.gov processed this record on November 23, 2014
||Joseph D. Tobias, Chairman Dept. of Anesthesiology & Pain Medicine, Nationwide Children's Hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 27, 2011
||November 29, 2012
||United States: Institutional Review Board