Comparison of Two Resuscitative Thoracotomy Techniques

NCT04242160 | Completed

• 1 other identifier: C.2017.172e
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Resuscitative thoracotomy (RT) is a life saving procedure for patients who have suffered cardiac arrest or are at significant risk of cardiac arrest following significant trauma. The procedure is ideally performed by a surgeon, but in some circumstance must be performed by non-surgical specialists such as Emergency Medicine physicians. The purpose of this study was to evaluate the optimal RT technique taught to non-surgical specialists in an educational human cadaver lab. The objective was to compare time to successful completion of two different RT techniques; (1) Left Anterolateral Thoracotomy (LAT) and (2) Modified Clamshell Thoracotomy (MCT). The investigators hypothesized that the non-surgical specialist time to successful completion for the MCT would be shorter than for the LAT.

Conditions

Emergencies; Trauma; Procedural Training; Thoracotomy

Outcome Measures

Primary Outcomes (1)

• Time to successful completion of RT procedure

  Time participant took to complete a successful RT procedure. Success includes (1) successful delivery of the heart and (2) successful cross-clamp of the descending thoracic aorta. Success determined by general surgeon observer. Time start from command "go" until participant verbalizes delivery of the heart and cross-clamp of the aorta.

  During procedure on data collection date

Secondary Outcomes (7)

• Successful delivery of the heart defined as exposure and inspection of all surfaces

  During procedure on data collection date

• Successful descending thoracic aorta cross-clamp defined as 100% occlusion of the descending aorta with a vascular clamp

  During procedure on data collection date

• Time to delivery of the heart defined as exposure and inspection of all surfaces

  During procedure on data collection date

• Time to descending thoracic aorta cross clamp defined as 100% occlusion of the descending aorta with a vascular clamp

  During procedure on data collection date

• Occurrence of iatrogenic injuries

  During procedure on data collection date

Study Arms (2)

Modified Clamshell Thoracotomy First

EXPERIMENTAL

Participants randomized to perform the MCT first, then cross over to the perform the alternate LAT.

Other: Modified Clamshell Thoracotomy; Other: Left Anterolateral Thoracotomy

Left Anterolateral Thoracotomy First

ACTIVE COMPARATOR

Participants randomized to perform the LAT first, then cross over to the perform the alternate MCT.

Other: Modified Clamshell Thoracotomy; Other: Left Anterolateral Thoracotomy

Interventions

Modified Clamshell Thoracotomy OTHER

Participants received standardized training on performing a MCT and LAT. Participants then performed the procedures on a fresh human cadaver model.

Left Anterolateral Thoracotomy First; Modified Clamshell Thoracotomy First

Left Anterolateral Thoracotomy OTHER

Participants received standardized training on performing a MCT and LAT. Participants then performed the procedures on a fresh human cadaver model.

Left Anterolateral Thoracotomy First; Modified Clamshell Thoracotomy First

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• licensed physician
• emergency medicine residency trainee or graduate
• privileged provider at SAMMC

You may not qualify if:

• \- unwilling to participate

Sponsors & Collaborators

• Brooke Army Medical Center: lead
• United States Army Institute of Surgical Research: collaborator
• United States Air Force En Route Care Research Center: collaborator
• Centre for Emergency Health Sciences: collaborator
• Barts & The London NHS Trust: collaborator
• The Institute of Pre-Hospital Care at London's Air Ambulance: collaborator
• US Air Force 711th Human Performance Wing: collaborator

Study Sites (1)

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

Related Publications (1)

• Newberry R, Brown D, Mitchell T, Maddry JK, Arana AA, Achay J, Rahm S, Long B, Becker T, Grier G, Davies G. Prospective Randomized Trial of Standard Left Anterolateral Thoracotomy Versus Modified Bilateral Clamshell Thoracotomy Performed by Emergency Physicians. Ann Emerg Med. 2021 Mar;77(3):317-326. doi: 10.1016/j.annemergmed.2020.05.042. Epub 2020 Aug 15.

  PMID: 32807537 DERIVED

MeSH Terms

Conditions

Emergencies; Wounds and Injuries

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emergency Medicine Physician

Model Details: Participants were randomized to the order of intervention. After completing the first RT technique assigned, participants complete the alternative RT technique

Study Record Dates

• First Submitted: January 19, 2020
• First Posted: January 27, 2020
• Study Start: November 19, 2018
• Primary Completion: March 27, 2019
• Study Completion: March 27, 2019
• Last Updated: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)