Can Postoperative Outcomes be Predicted From Asking OSA Screening Questions Pre-operatively?

February 3, 2022 updated by: Vidya Raman, Nationwide Children's Hospital
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The survey will be administered preoperatively in the ENT clinic or the preoperative surgical unit. The following data will also be recorded: patient demographics (age, gender, BMI), surgical procedure, length of procedure and anesthetic, and smoking exposure. Based on differences in postoperative outcomes (e.g., supplemental oxygen requirement in the PACU) observed in the derivation cohort for the 6-item questionnaire, the study will enroll 1,000 patients to attain sufficient power for evaluating the 6-item questionnaire in the overall cohort and in demographically or clinically defined subgroups.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Emergency surgery and any caregiver or patient refusal.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Children undergoing surgery
Children ages 3-18 undergoing a surgical procedure at Nationwide Children's Hosp.
Other: Survey
Completing a survey on RedCap

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Liters of Oxygen
Time Frame: 1 hr post-op
The patient's oxygen requirement while in the PACU.
1 hr post-op

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Narcotic usage in mg
Time Frame: 1 hr post-op
The patient's opiod requirement while in the PACU.
1 hr post-op
PACU length of stay
Time Frame: 1-2 hr post-op
1-2 hr post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nationwide Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2016

Primary Completion (Actual)

November 2, 2021

Study Completion (Actual)

November 2, 2021

Study Registration Dates

First Submitted

September 15, 2016

First Submitted That Met QC Criteria

October 10, 2016

First Posted (Estimate)

October 12, 2016

Study Record Updates

Last Update Posted (Actual)

February 14, 2022

Last Update Submitted That Met QC Criteria

February 3, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB16-00491

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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