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NCT05138536 Clinical Trial

CT Change Management in Trauma Patients

Trauma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05138536
Other study ID # 024.TRA.2016.D
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 6, 2020
Est. completion date March 6, 2020

Study information
Verified date November 2021
Source Methodist Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 510
Est. completion date March 6, 2020
Est. primary completion date March 6, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Pan-Computer Tomography
trauma centers use the pan-computed tomography (CT) scan (head, neck, chest, and abdomen/pelvis) for the evaluation of blunt trauma.

Locations
Country Name City State
United States Methodist Dallas Medical Center Dallas Texas

Sponsors (1)
Lead Sponsor Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of trauma patients with no known neurologic deficits who underwent a CT the benefit of pan-CT with no neurologic deficits April 2006 - April 2016
Secondary 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 April 2006 - April 2016
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