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Resuscitative Thoracotomy PracticesNCT05944003

Resuscitative Thoracotomy Practices

An observational study of Resuscitative Thoracotomy Practices, run by Methodist Health System at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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]. Read more about this study

Who is it for?
Ages 16 to 75 years
Conditions the study is for
Resuscitative Thoracotomy Practices
What is being tested?
Resuscitative thoracotomies
Type of treatment
Surgery or procedure
How many people
500 participants
Where
1 siteUnited States
Study dates
18 May 2022to 18 Sep 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Methodist Dallas Medical Center

    Dallas, Texas, 75203

Other trials in United States

About this study

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].

Read the 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.

Being tested
Resuscitative thoracotomies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Resuscitative thoracotomiesProcedure or surgery

    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-

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 2 years

Secondary outcomes (1)
  1. • 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

    Measured: 2 yrs

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2023
  2. Study start18 May 2022
  3. Primary completion10 Sep 2025
  4. Study completion18 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05944003
Sponsor's protocol ID
015.TRA.2022.D
Status last verified
Apr 2026
First submitted
6 Jul 2023
Last updated
10 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

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.

    PubMed 23188227
  • 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.

    PubMed 21307731
  • 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.

    PubMed 26091330
  • 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.

    PubMed 33032791
  • 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.

    PubMed 32028977
  • 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.

    PubMed 10703853
  • 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.

    PubMed 15275875
  • 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.

    PubMed 32622163
  • 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.

    PubMed 26258320
  • 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.

    PubMed 17461305

Questions about this trial

What is this clinical trial studying?

An observational study of Resuscitative Thoracotomy Practices, run by Methodist Health System at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total number of RT (before and during the COVID-19 pandemic) (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05944003, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026; AzTrials last refreshed its copy on 29 Oct 2026.

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