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Adenotonsillectomy and Obstructive Sleep Apnea Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joseph D. Tobias, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01462539
First received: October 27, 2011
Last updated: November 29, 2012
Last verified: November 2012
History of Changes
  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

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

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)
Groups/Cohorts
OSAS group
Non-OSAS group

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: October 27, 2011
Last Updated: November 29, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
 Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 19, 2013