Trials / Withdrawn
WithdrawnNCT02930538
Can Postoperative Outcomes be Predicted From Asking OSA Screening Questions Pre-operatively?
- Status
- Withdrawn
- Phase
- —
- Study type
- Observational
- Enrollment
- 0 (actual)
- Sponsor
- Nationwide Children's Hospital · Academic / Other
- Sex
- All
- Age
- 3 Years – 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Survey | Completing a survey on RedCap |
Timeline
- Start date
- 2016-11-22
- Primary completion
- 2021-11-02
- Completion
- 2021-11-02
- First posted
- 2016-10-12
- Last updated
- 2022-02-14
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02930538. Inclusion in this directory is not an endorsement.