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Adenotonsillectomy and Obstructive Sleep Apnea Study

NCT ID: NCT01462539

Last Updated: 2012-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Adenotonsillectomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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OSAS group

No interventions assigned to this group

Non-OSAS group

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nationwide Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Joseph D. Tobias

Chairman Dept. of Anesthesiology & Pain Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vidya Raman, MD

Role: PRINCIPAL_INVESTIGATOR

Nationwide Childrens Hospital

Locations

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Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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IRB11-00364

Identifier Type: -

Identifier Source: org_study_id