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

Sponsor

Nationwide Children's Hospital (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02930538

Collaborator

(none)

Enrollment

Location

59.3

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea	Other: Survey

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 Design

Study Type:

Observational

Actual Enrollment :

0 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Actual Study Start Date :

Nov 22, 2016

Actual Primary Completion Date :

Nov 2, 2021

Actual Study Completion Date :

Nov 2, 2021

Arms and Interventions

Arm	Intervention/Treatment
Children undergoing surgery Children ages 3-18 undergoing a surgical procedure at Nationwide Children's Hosp.	Other: Survey Completing a survey on RedCap

Arm

Intervention/Treatment

Children undergoing surgery

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

Other: Survey

Completing a survey on RedCap

Outcome Measures

Primary Outcome Measures

Liters of Oxygen [1 hr post-op]
The patient's oxygen requirement while in the PACU.

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nationwide Children's Hospital	Columbus	Ohio	United States	43205

Sponsors and Collaborators

Nationwide Children's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Vidya Raman, Clinical Associate Professor of Anesthesiology, Nationwide Children's Hospital

ClinicalTrials.gov Identifier:

NCT02930538

Other Study ID Numbers:

IRB16-00491

First Posted:

Oct 12, 2016

Last Update Posted:

Feb 14, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Additional relevant MeSH terms:

Sleep Apnea, Obstructive

Study Results

No Results Posted as of Feb 14, 2022