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Clinical Trials/NCT02930538
NCT02930538
Withdrawn
N/A

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

Nationwide Children's Hospital1 site in 1 countryNovember 22, 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Obstructive Sleep Apnea
Sponsor
Nationwide Children's Hospital
Locations
1
Primary Endpoint
Liters of Oxygen
Status
Withdrawn
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 22, 2016
End Date
November 2, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Vidya Raman

Clinical Associate Professor of Anesthesiology

Nationwide Children's Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Liters of Oxygen

Time Frame: 1 hr post-op

The patient's oxygen requirement while in the PACU.

Secondary Outcomes

  • Narcotic usage in mg(1 hr post-op)
  • PACU length of stay(1-2 hr post-op)

Study Sites (1)

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