Adenotonsillectomy and Obstructive Sleep Apnea Study | NCT01462539

Studies
Adenotonsillectomy and Obstructive Sleep Apnea Study

NCT01462539

Sponsor

Nationwide Children's Hospital

Status

Completed

Last Update Posted

Nov 30, 2012Estimated

Enrollment

200Actual

Phase

Not provided

Conditions

Adenotonsillectomy

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2011

Primary Completion Date

Aug 2012Actual

Completion Date

Oct 2012Actual

First Submitted Date

Oct 27, 2011

First Submission Date that Met QC Criteria

Oct 28, 2011

First Posted Date

Oct 31, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 29, 2012

Last Update Posted Date

Nov 30, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Joseph D. Tobias, Chairman Dept. of Anesthesiology & Pain Medicine, Nationwide Children's HospitalPrincipal Investigator

Lead Sponsor

Nationwide Children's HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Length of stay (LOS)		1 Day (Day of Surgery)

Secondary Outcomes

Measure	Description	Time Frame
Cause of increased Length of stay (LOS)		1 Day (Day of Surgery)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Preoperatively requiring additional respiratory support
scheduled for concurrent surgery that could increase total general anesthetic time
recurrent adenotonsillitis as sole indication for surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

6 Years

Standard Ages

Child

Study Population

Patients undergoing adenotonsillectomy only with no concurrent surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vidya Raman, MD	Nationwide Childrens Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nationwide Children's Hospital		Columbus	Ohio	43205	United States

Label	Type	Description	Intervention Names
OSAS group
Non-OSAS group