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WithdrawnNCT03436667Updated Sep 14, 2022

Perioperative Factors Impacting Surgical Risk and Outcomes in Children

An observational study in Surgery and Orthopedic Disorder, sponsored by Nationwide Children's Hospital. Withdrawn at 1 site in United States. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2022-09-14.

Sponsored by Nationwide Children's Hospital · Observational

Why this study was withdrawn
PI left the institution
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
6 Years to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Surgery
  • Orthopedic Disorder
03

Who can participate

Ages eligible
6 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

  • Spinal fusion
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • Orthopedic surgery

    Pediatric patients presenting for ambulatory orthopedic procedures

    Diagnostic Test: Spirometry · Diagnostic Test: Reaction Time

Interventions

  • Diagnostic testSpirometry

    Lung volumes will be measured using spirometry.

  • Diagnostic testReaction Time

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

05

What researchers measure

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

    Time frame: Immediately post-op

06

Study locations

1 site
  • Nationwide Children's Hospital
    Columbus, Ohio 43205, United States
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03436667
Lead sponsor
Nationwide Children's Hospital
Responsible party
Vidya Raman (Clinical Associate Professor, Nationwide Children's Hospital) — Principal investigator
First posted
Feb 19, 2018
Start date
Sep 19, 2018
Primary completion
Jun 1, 2022
Completion
Jun 1, 2022
Last update
Sep 14, 2022

Study contacts

Vidya Raman, MD
principal investigator · Nationwide Children's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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