- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05944003
Resuscitative Thoracotomy Practices
June 8, 2026 updated by: Methodist Health System
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].
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
500
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
-
-
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
- Child
- Adult
- Older Adult
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.
Description
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.
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 |
|---|---|---|
|
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
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
• 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
|
2 yrs
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Burlew CC, Moore EE, Moore FA, Coimbra R, McIntyre RC Jr, Davis JW, Sperry J, Biffl WL. Western Trauma Association critical decisions in trauma: resuscitative thoracotomy. J Trauma Acute Care Surg. 2012 Dec;73(6):1359-63. doi: 10.1097/TA.0b013e318270d2df.
- Moore EE, Knudson MM, Burlew CC, Inaba K, Dicker RA, Biffl WL, Malhotra AK, Schreiber MA, Browder TD, Coimbra R, Gonzalez EA, Meredith JW, Livingston DH, Kaups KL; WTA Study Group. Defining the limits of resuscitative emergency department thoracotomy: a contemporary Western Trauma Association perspective. J Trauma. 2011 Feb;70(2):334-9. doi: 10.1097/TA.0b013e3182077c35.
- Seamon MJ, Haut ER, Van Arendonk K, Barbosa RR, Chiu WC, Dente CJ, Fox N, Jawa RS, Khwaja K, Lee JK, Magnotti LJ, Mayglothling JA, McDonald AA, Rowell S, To KB, Falck-Ytter Y, Rhee P. An evidence-based approach to patient selection for emergency department thoracotomy: A practice management guideline from the Eastern Association for the Surgery of Trauma. J Trauma Acute Care Surg. 2015 Jul;79(1):159-73. doi: 10.1097/TA.0000000000000648.
- Aseni P, Rizzetto F, Grande AM, Bini R, Sammartano F, Vezzulli F, Vertemati M. Emergency Department Resuscitative Thoracotomy: Indications, surgical procedure and outcome. A narrative review. Am J Surg. 2021 May;221(5):1082-1092. doi: 10.1016/j.amjsurg.2020.09.038. Epub 2020 Oct 2.
- Hughes M, Perkins Z. Outcomes following resuscitative thoracotomy for abdominal exsanguination, a systematic review. Scand J Trauma Resusc Emerg Med. 2020 Feb 6;28(1):9. doi: 10.1186/s13049-020-0705-4.
- Rhee PM, Acosta J, Bridgeman A, Wang D, Jordan M, Rich N. Survival after emergency department thoracotomy: review of published data from the past 25 years. J Am Coll Surg. 2000 Mar;190(3):288-98. doi: 10.1016/s1072-7515(99)00233-1.
- Powell DW, Moore EE, Cothren CC, Ciesla DJ, Burch JM, Moore JB, Johnson JL. Is emergency department resuscitative thoracotomy futile care for the critically injured patient requiring prehospital cardiopulmonary resuscitation? J Am Coll Surg. 2004 Aug;199(2):211-5. doi: 10.1016/j.jamcollsurg.2004.04.004.
- Panossian VS, Nederpelt CJ, El Hechi MW, Chang DC, Mendoza AE, Saillant NN, Velmahos GC, Kaafarani HMA. Emergency Resuscitative Thoracotomy: A Nationwide Analysis of Outcomes and Predictors of Futility. J Surg Res. 2020 Nov;255:486-494. doi: 10.1016/j.jss.2020.05.048. Epub 2020 Jul 1.
- Inaba K, Chouliaras K, Zakaluzny S, Swadron S, Mailhot T, Seif D, Teixeira P, Sivrikoz E, Ives C, Barmparas G, Koronakis N, Demetriades D. FAST ultrasound examination as a predictor of outcomes after resuscitative thoracotomy: a prospective evaluation. Ann Surg. 2015 Sep;262(3):512-8; discussion 516-8. doi: 10.1097/SLA.0000000000001421.
- Soreide K, Petrone P, Asensio JA. Emergency thoracotomy in trauma: rationale, risks, and realities. Scand J Surg. 2007;96(1):4-10. doi: 10.1177/145749690709600102.
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)
May 18, 2022
Primary Completion (Actual)
September 10, 2025
Study Completion (Actual)
September 18, 2025
Study Registration Dates
First Submitted
July 6, 2023
First Submitted That Met QC Criteria
July 6, 2023
First Posted (Actual)
July 13, 2023
Study Record Updates
Last Update Posted (Actual)
June 10, 2026
Last Update Submitted That Met QC Criteria
June 8, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- 015.TRA.2022.D
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD 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.
IPD Sharing Time Frame
with in 1-2 years
IPD Sharing 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), Eastern Association for the Surgery of Trauma, WTA (Western Trauma Association), or similar.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
- CSR
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.