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NCT03436667 Clinical Trial

Perioperative Factors Impacting Surgical Risk and Outcomes in Children

Surgery Clinical Trial

Official title:
Perioperative Factors Impacting Surgical Risk and Outcomes in Children

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03436667
Other study ID # IRB18-00068
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date September 19, 2018
Est. completion date June 1, 2022

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

Clinical Trial Summary

This prospective study will measure various factors in children coming in for ambulatory surgery and attempt to create a scoring system that would be able to predict post-operative outcomes.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date June 1, 2022
Est. primary completion date June 1, 2022
Accepts healthy volunteers No
Gender All
Age group 6 Years to 18 Years
Eligibility Inclusion Criteria: - Pediatric patients aged 6-18 years old having ambulatory orthopedic surgery with or without planned postoperative admission. - Patients need to be cooperative to under spirometry testing and reaction time measurement. If unable to perform, we will assess why they were not able (non-cooperative, inability, etc) Exclusion Criteria: - Spinal fusion

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Spirometry
Lung volumes will be measured using spirometry.
• Reaction Time
PVT-192 Psychomotor Vigilance Task Monitor is a hand-held, self-contained system used for repetitive reaction time measurement.

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 Post-anesthesia care unit (PACU) length of stay The investigators hypothesize that spirometry performance will be associated with reduced PACU length of stay Immediately post-op
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