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

Withdrawn

• Conditions: Obstructive Sleep Apnea
• Interventions: Other: Survey

• Registration Number: NCT02930538
• Lead Sponsor: Nationwide Children's Hospital

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.

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 Timeline

• Study First Submitted: 2016-09-15
• Study First Submitted QC: 2016-10-10
• Study First Posted: 2016-10-12
• Study Start: 2016-11-22
• Primary Completion: 2021-11-02
• Study Completion: 2021-11-02
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-03
• Last Update Posted: 2022-02-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children undergoing surgery	Survey	Children ages 3-18 undergoing a surgical procedure at Nationwide Children's Hosp.

Primary Outcome Measures

Name	Time	Method
Liters of Oxygen	1 hr post-op	The patient's oxygen requirement while in the PACU.

Secondary Outcome Measures

Name	Time	Method
Narcotic usage in mg	1 hr post-op	The patient's opiod requirement while in the PACU.
PACU length of stay	1-2 hr post-op

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States