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

NCT ID: NCT02930538

Last Updated: 2022-02-14

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-22

Study Completion Date

2021-11-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obstructive Sleep Apnea

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Children undergoing surgery

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

Survey

Intervention Type OTHER

Completing a survey on RedCap

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Survey

Completing a survey on RedCap

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Nationwide Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Vidya Raman

Clinical Associate Professor of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB16-00491

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Physical Status of OSA Patients
NCT05051514 COMPLETED