Comparison of Two Resuscitative Thoracotomy Techniques

Not Applicable

Completed

• Conditions: Emergencies; Procedural Training; Trauma; Thoracotomy
• Interventions: Other: Modified Clamshell Thoracotomy; Other: Left Anterolateral Thoracotomy

• Registration Number: NCT04242160
• Lead Sponsor: Brooke Army Medical Center

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.

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 Timeline

• Study Start: 2018-11-19
• Primary Completion: 2019-03-27
• Study Completion: 2019-03-27
• Status Verified: 2020-01
• Study First Submitted: 2020-01-19
• Study First Submitted QC: 2020-01-22
• Last Update Submitted: 2020-01-22
• Study First Posted: 2020-01-27
• Last Update Posted: 2020-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

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

Exclusion Criteria

• unwilling to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Modified Clamshell Thoracotomy First	Modified Clamshell Thoracotomy	Participants randomized to perform the MCT first, then cross over to the perform the alternate LAT.
Left Anterolateral Thoracotomy First	Modified Clamshell Thoracotomy	Participants randomized to perform the LAT first, then cross over to the perform the alternate MCT.
Left Anterolateral Thoracotomy First	Left Anterolateral Thoracotomy	Participants randomized to perform the LAT first, then cross over to the perform the alternate MCT.
Modified Clamshell Thoracotomy First	Left Anterolateral Thoracotomy	Participants randomized to perform the MCT first, then cross over to the perform the alternate LAT.

Primary Outcome Measures

Name	Time	Method
Time to successful completion of RT procedure	During procedure on data collection date	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Brooke Army Medical Center; 🇺🇸 Fort Sam Houston, Texas, United States