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NCT02930538 Clinical Trial

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

Obstructive Sleep Apnea Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02930538
Other study ID # IRB16-00491
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date November 22, 2016
Est. completion date November 2, 2021

Study information
Verified date February 2022
Source Nationwide Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date November 2, 2021
Est. primary completion date November 2, 2021
Accepts healthy volunteers No
Gender All
Age group 3 Years to 18 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Survey
Completing a survey on RedCap

Locations
Country Name City State
United States Nationwide Children's Hospital Columbus Ohio

Sponsors (1)
Lead Sponsor Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Liters of Oxygen The patient's oxygen requirement while in the PACU. 1 hr post-op
Secondary Narcotic usage in mg The patient's opiod requirement while in the PACU. 1 hr post-op
Secondary PACU length of stay 1-2 hr post-op
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