Perioperative Factors Impacting Surgical Risk and Outcomes in Children

NCT ID: NCT03436667

Last Updated: 2022-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-19

Study Completion Date

2022-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Surgery Orthopedic Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Orthopedic surgery

Pediatric patients presenting for ambulatory orthopedic procedures

Spirometry

Intervention Type DIAGNOSTIC_TEST

Lung volumes will be measured using spirometry.

Reaction Time

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Spirometry

Lung volumes will be measured using spirometry.

Intervention Type DIAGNOSTIC_TEST

Reaction Time

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nationwide Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Vidya Raman

Clinical Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vidya Raman, MD

Role: PRINCIPAL_INVESTIGATOR

Nationwide Children's Hospital

Locations

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Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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IRB18-00068

Identifier Type: -

Identifier Source: org_study_id

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