Resuscitative Thoracotomy Practices

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: Enrolling by invitation
• Conditions: Resuscitative Thoracotomy Practices
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

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)	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)	• 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

• Sponsor: Methodist Health System

Publications and helpful links

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

Study Major Dates

• Study Start (Actual): May 18, 2022
• Primary Completion (Estimated): May 18, 2024
• Study Completion (Estimated): May 18, 2024

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): July 13, 2023
• Last Update Submitted That Met QC Criteria: July 6, 2023
• Last Verified: July 1, 2023

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), EAST (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