Comparison of Two Resuscitative Thoracotomy Techniques

Prospective Randomized Trial of Standard Left Anterolateral Thoracotomy vs Modified Bilateral Clamshell Thoracotomy Performed by Emergency Physicians

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.

Study Overview

• Status: Completed
• Conditions: Emergencies; Trauma; Thoracotomy; Procedural Training
• Intervention / Treatment: Other: Modified Clamshell Thoracotomy; Other: Left Anterolateral Thoracotomy

Detailed Description

The investigators conducted a randomized crossover trial of two resuscitative thoracotomy techniques performed by Emergency Medicine (EM) physicians using a fresh human cadaver model. The purpose was to identify the ideal technique to be taught to non-surgical specialists in a training lab setting. The two techniques compared were the Left Anterolateral Thoracotomy (LAT), commonly taught to EM physicians in the United States, and the Modified Clamshell Thoracotomy (MCT) taught by London's Air Ambulance. The investigators hypothesized that the non-surgical specialists time to successful completion of the RT would be faster when performing the MCT compared to the LAT.

The investigators conducted this study at a large level 1 trauma center with an Emergency Medicine residency program and recruited Emergency Medicine residents and staff physicians to participate. Participants were trained on the MCT as performed by LAA and reviewed the LAT technique in a standardized fashion. Participants were then randomized to order of intervention, and conducted each procedure on a separate fresh human cadaver. Participants were evaluated on time to successful completion of the procedure, successful completion of procedural steps, and identification of anatomy. Cadaver specimens were examined for iatrogenic injuries. Participants then completed a standardized survey regarding each procedure.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fort Sam Houston, Texas, United States, 78234
      • Brooke Army Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

- unwilling to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Modified Clamshell Thoracotomy First; Participants randomized to perform the MCT first, then cross over to the perform the alternate LAT.	Other: Modified Clamshell Thoracotomy; Participants received standardized training on performing a MCT and LAT. Participants then performed the procedures on a fresh human cadaver model.; Other: Left Anterolateral Thoracotomy; Participants received standardized training on performing a MCT and LAT. Participants then performed the procedures on a fresh human cadaver model.
Active Comparator: Left Anterolateral Thoracotomy First; Participants randomized to perform the LAT first, then cross over to the perform the alternate MCT.	Other: Modified Clamshell Thoracotomy; Participants received standardized training on performing a MCT and LAT. Participants then performed the procedures on a fresh human cadaver model.; Other: Left Anterolateral Thoracotomy; Participants received standardized training on performing a MCT and LAT. Participants then performed the procedures on a fresh human cadaver model.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful delivery of the heart defined as exposure and inspection of all surfaces	Determined by General Surgeon observer	During procedure on data collection date
Successful descending thoracic aorta cross-clamp defined as 100% occlusion of the descending aorta with a vascular clamp	Determined by General Surgeon observer	During procedure on data collection date
Time to delivery of the heart defined as exposure and inspection of all surfaces	time from command "go" to subject verbalizing delivery of heart	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	total elapsed time from command "go" to subject verbalizing successful cross-clamping of the descending thoracic aorta	During procedure on data collection date
Occurrence of iatrogenic injuries	Injury to phrenic nerve, esophagus, lung, heart or other anatomical structure as identified by a General Surgeon AI.	During procedure on data collection date
Successful identification of anatomy	Successful identification of the phrenic nerve, right atrium, left atrium, right ventricle, left ventricle, pulmonary hilum, descending thoracic aorta, and esophagus.	During procedure on data collection date
Subject Questionnaire	Procedural ease, comfort, view, equipment comfort and preference.	During procedure on data collection date

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2018
• Primary Completion (Actual): March 27, 2019
• Study Completion (Actual): March 27, 2019

Study Registration Dates

• First Submitted: January 19, 2020
• First Submitted That Met QC Criteria: January 22, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 22, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: C.2017.172e

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No