Comparison of Two Resuscitative Thoracotomy Techniques

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Emergencies, Trauma, Procedural Training, Thoracotomy

Intervention / Treatment
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* Other: Modified Clamshell Thoracotomy
* Other: Left Anterolateral Thoracotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: licensed physician emergency medicine residency trainee or graduate privileged provider at SAMMC Exclusion Criteria: - unwilling to participate
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Participants were randomized to the order of intervention. After completing the first RT technique assigned, participants complete the alternative RT technique
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |