Perioperative Factors Impacting Surgical Risk and Outcomes in Children

NCT03436667 — Withdrawn, Nationwide Children's Hospital

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Registry	NCT03436667
Status	Withdrawn - PI left the institution
Study type	Observational
Sponsor	Nationwide Children's Hospital (Other)
Conditions	Surgery, Orthopedic Disorder
Interventions	Spirometry, Reaction Time (Diagnostic test)
Dates	start 2018-09-19, primary completion 2022-06-01, completion 2022-06-01, first posted 2018-02-19, last updated 2022-09-14
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Orthopedic surgery		Diagnostic Test: Spirometry; Diagnostic Test: Reaction Time	Pediatric patients presenting for ambulatory orthopedic procedures

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

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 6 Years to 18 Years

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

+Locations (1)

Facility	City	Country	Status
Nationwide Children's Hospital	Columbus, Ohio	United States

+Investigators

Vidya Raman, MD, Principal investigator, Nationwide Children's Hospital

My Notes

Public

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