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Resuscitative Thoracotomy Practices

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ClinicalTrials.gov Identifier: NCT05944003
Recruitment Status : Enrolling by invitation
First Posted : July 13, 2023
Last Update Posted : July 13, 2023
Sponsor:
Information provided by (Responsible Party):
Methodist Health System

Study Description
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Brief Summary:
Resuscitative thoracotomies (RT) are an effective life saving measure in appropriate populations [1-8]. Unfortunately, when used outside of these populations the mortality rate is typically more than 90% [1-8]. Western Trauma Association and Eastern Association for the Surgery of Trauma have provided guidelines for which trauma patients are a candidate for RT [1-3].

Condition or disease Intervention/treatment
Resuscitative Thoracotomy Practices Procedure: Resuscitative thoracotomies

Detailed Description:
EPIC and trauma registry will be queried for demographic information, admission dates, discharge diagnoses, inpatient cognitive function, routine testing (imaging and labs) reports, and surgical histories to determine number of patients who underwent RT, survived the RT, deficits from their cardiac arrest, and if they were COVID-19 positive. A full list of variables to be extracted from the chart review is in Appendix B. Chart review and data collection for these patients should be completed by December of 2024.
Study Design
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Resuscitative Thoracotomy Practices
Actual Study Start Date : May 18, 2022
Estimated Primary Completion Date : May 18, 2024
Estimated Study Completion Date : May 18, 2024
Groups and Cohorts
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Intervention Details:
  • Procedure: Resuscitative thoracotomies
    Resuscitative thoracotomies is an effective life saving measure in appropriate populations [1-8]. Unfortunately, when used outside of these populations the mortality rate is typically more than 90% [1-8]. Western Trauma Association and Eastern Association for the Surgery of Trauma have provided guidelines for which trauma patients are a candidate for RT [1-

Outcome Measures
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Primary Outcome Measures :
  1. Total number of RT (before and during the COVID-19 pandemic) [ Time Frame: 2 years ]
    Determine the rate of RT at MDMC. Particularly, if there was an increase during the COVID-19 pandemic, which would lead to greater exposure to transmissible disease


Secondary Outcome Measures :
  1. • Cognitive deficits of any survivors of RT (GCS, assessments by neurology, mental status exams, and/or similar assessments documented in the EMR) [ Time Frame: 2 yrs ]
    • Determine the rate of RT at MDMC. Particularly, if there was an increase during the COVID-19 pandemic, which would lead to greater exposure to transmissible disease


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Trauma patients who underwent RT in the emergency department (ED), operating room (OR), or intensive care unit (ICU) from January 1, 2017 to December 31, 2023.
Criteria

Inclusion Criteria:

  • Trauma patients who underwent RT in the emergency department (ED), operating room (OR), or intensive care unit (ICU) from January 1, 2017 to December 31, 2023.

Exclusion Criteria:

  • Trauma patients who did not have a RT in the ED, OR, or ICU or were less than 16 years old from January 1, 2017 to December 31, 2023.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05944003


Locations
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United States, Texas
Methodist Dallas Medical Center
Dallas, Texas, United States, 75203
Sponsors and Collaborators
Methodist Health System
More Information
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Publications:

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Responsible Party: Methodist Health System
ClinicalTrials.gov Identifier: NCT05944003    
Other Study ID Numbers: 015.TRA.2022.D
First Posted: July 13, 2023    Key Record Dates
Last Update Posted: July 13, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Study data or any protected health information will not be shared with anyone that is not delegated to the study. The PI is committed to disseminate research results in a timely fashion. Sharing of results generated by the data analysis during the course of the project will be through presentation at national scientific meetings and/or publication in open access journals. All information obtained will be source de-identified and presented on a large scale and not traceable to any one particular individual.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: with in 1-2 years
Access Criteria: The data will be presented at local, regional, national, and international sites. The research gathered will be analyzed and submitted to relevant peer-reviewed medical journals for publication to add to the body of knowledge in the science community. Our potential list of conferences include: AAST (American Association for the Surgery of Trauma), SWSC (Southwest Surgical Congress), EAST (Eastern Association for the Surgery of Trauma), WTA (Western Trauma Association), or similar.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No