Perioperative Factors Impacting Surgical Risk and Outcomes in Children

NCT03436667 | Withdrawn

• 1 other identifier: IRB18-00068
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Surgery; Orthopedic Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Orthopedic surgery

Pediatric patients presenting for ambulatory orthopedic procedures

Diagnostic Test: Spirometry; Diagnostic Test: Reaction Time

Interventions

Spirometry DIAGNOSTIC_TEST

Lung volumes will be measured using spirometry.

Orthopedic surgery

Reaction Time DIAGNOSTIC_TEST

PVT-192 Psychomotor Vigilance Task Monitor is a hand-held, self-contained system used for repetitive reaction time measurement.

Orthopedic surgery

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing ambulatory orthopedic surgery at Nationwide Children's Hospital.

You may qualify if:

• 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)

You may not qualify if:

• Spinal fusion

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Musculoskeletal Diseases

Interventions

Spirometry; Reaction Time

Intervention Hierarchy (Ancestors)

Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Psychological Techniques; Investigative Techniques; Behavioral Disciplines and Activities; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Vidya Raman, MD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: February 12, 2018
• First Posted: February 19, 2018
• Study Start: September 19, 2018
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: September 14, 2022

Record last verified: 2022-09

Locations

US (1)