NCT02930538

Brief Summary

The proposed research will determine whether a 6-item screening questionnaire previously shown to correlate with moderate or severe OSA is useful for predicting postoperative outcomes in children undergoing surgery under general anesthesia.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2016

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 12, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

November 22, 2016

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2021

Completed
Last Updated

February 14, 2022

Status Verified

February 1, 2022

Enrollment Period

4.9 years

First QC Date

September 15, 2016

Last Update Submit

February 3, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Liters of Oxygen

    The patient's oxygen requirement while in the PACU.

    1 hr post-op

Secondary Outcomes (2)

  • Narcotic usage in mg

    1 hr post-op

  • PACU length of stay

    1-2 hr post-op

Study Arms (1)

Children undergoing surgery

Children ages 3-18 undergoing a surgical procedure at Nationwide Children's Hosp.

Other: Survey

Interventions

SurveyOTHER

Completing a survey on RedCap

Children undergoing surgery

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children having surgery at Nationwide Children's Hosp (NCH).

You may qualify if:

  • The study will include all who are presenting for surgery to the main operating room, ambulatory surgical center or procedure center at Nationwide Children's Hospital.

You may not qualify if:

  • Emergency surgery and any caregiver or patient refusal.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor of Anesthesiology

Study Record Dates

First Submitted

September 15, 2016

First Posted

October 12, 2016

Study Start

November 22, 2016

Primary Completion

November 2, 2021

Study Completion

November 2, 2021

Last Updated

February 14, 2022

Record last verified: 2022-02

Locations