NCT01462539

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

October 27, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 31, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

November 30, 2012

Status Verified

November 1, 2012

Enrollment Period

10 months

First QC Date

October 27, 2011

Last Update Submit

November 29, 2012

Conditions

Adenotonsillectomy

Outcome Measures

Primary Outcomes (1)

  • Length of stay (LOS)

    1 Day (Day of Surgery)

Secondary Outcomes (1)

  • Cause of increased Length of stay (LOS)

    1 Day (Day of Surgery)

Study Arms (2)

OSAS group

Non-OSAS group

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing adenotonsillectomy only with no concurrent surgery

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Study Officials

  • Vidya Raman, MD

    Nationwide Childrens Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman Dept. of Anesthesiology & Pain Medicine

Study Record Dates

First Submitted

October 27, 2011

First Posted

October 31, 2011

Study Start

October 1, 2011

Primary Completion

August 1, 2012

Study Completion

October 1, 2012

Last Updated

November 30, 2012

Record last verified: 2012-11

Locations

US(1)