CT Change Management in Trauma Patients

November 16, 2021 updated by: Methodist Health System

Does Comprehensive CT Change Management in Trauma Patients With no Neurologic Deficits

In high-volume trauma centers, multi-slice CT scanners have become the routine imaging modality for screening trauma patients due to their speed and accuracy. In trauma patients with no known neurologic deficits, diagnostic CT is often obtained though it remains unclear whether this affects management of the patient [1]. With the growing cost of health care, a careful look at the benefit and cost of CT is needed to determine how to best utilize this modality in the evaluation of trauma patients.

HYPOTHESIS: In trauma patients with absence of neurologic defects, the addition of comprehensive CT does not change overall clinical management.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objectives: The primary objective of this study is to determine the benefit of the CT scan in the clinical management or outcomes of the trauma patients with no neurologic deficits.

Primary Outcome: Percentage of trauma patients with no known neurologic deficits who underwent a CT, any clinically impactful CT findings.

Secondary Outcome: Percentage of benefits CT provides in clinical features, clinical outcomes, injury severity score, GCS, age, sex, ethnicity, cause of injury, mechanism of injury, hospital length of stay, operative vs. non-operative, discharge disposition, radilogy, pathology results and images, any additional morbidities, total cost, 30-day readmission rate, and morality. And when operation does occur, the types of operation and the resulting cost and length of stay.

Study Type

Observational

Enrollment (Actual)

510

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75203
        • Methodist Dallas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All trauma patients from Methodist Health System.

Description

Inclusion Criteria:

  • Age ≥ 18-years-old
  • No localizing neurologic defect
  • Any cause or mechanism of injury
  • Comprehensive CT obtained

Exclusion Criteria:

• Any patients that are pregnant or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of trauma patients with no known neurologic deficits who underwent a CT
Time Frame: April 2006 - April 2016
the benefit of pan-CT with no neurologic deficits
April 2006 - April 2016

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of benefits CT provides in clinical features
Time Frame: April 2006 - April 2016
Clinical outcomes, injury severity score, GCS, age, sex, ethnicity, cause of injury, mechanism of injury, hospital length of stay, operative vs non-operative
April 2006 - April 2016

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Methodist Health System

Investigators

  • Principal Investigator: Joseph Amos, MD, Methodist Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2020

Primary Completion (Actual)

March 6, 2020

Study Completion (Actual)

March 6, 2020

Study Registration Dates

First Submitted

April 3, 2019

First Submitted That Met QC Criteria

November 16, 2021

First Posted (Actual)

December 1, 2021

Study Record Updates

Last Update Posted (Actual)

December 1, 2021

Last Update Submitted That Met QC Criteria

November 16, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 024.TRA.2016.D

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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