Clinical trial NCT04242160: Comparison of Two Resuscitative Thoracotomy Techniques
Official title: Prospective Randomized Trial of Standard Left Anterolateral Thoracotomy vs Modified Bilateral Clamshell Thoracotomy Performed by Emergency Physicians
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emergencies
Trauma
Procedural Training
Thoracotomy
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
Collaborators: name: United States Army Institute of Surgical Research
name: United States Air Force En Route Care Research Center
name: Centre for Emergency Health Sciences
name: Barts & The London NHS Trust
name: The Institute of Pre-Hospital Care at London's Air Ambulance
name: US Air Force 711th Human Performance Wing
First posted: 2020-01-27
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants were randomized to the order of intervention. After completing the first RT technique assigned, participants complete the alternative RT technique
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

- unwilling to participate

Primary outcomes:
measure: Time to successful completion of RT procedure
timeFrame: During procedure on data collection date
Secondary outcomes:
measure: Successful delivery of the heart defined as exposure and inspection of all surfaces
timeFrame: During procedure on data collection date
measure: Successful descending thoracic aorta cross-clamp defined as 100% occlusion of the descending aorta with a vascular clamp
timeFrame: During procedure on data collection date
measure: Time to delivery of the heart defined as exposure and inspection of all surfaces
timeFrame: During procedure on data collection date
measure: Time to descending thoracic aorta cross clamp defined as 100% occlusion of the descending aorta with a vascular clamp
timeFrame: During procedure on data collection date
measure: Occurrence of iatrogenic injuries
timeFrame: During procedure on data collection date
measure: Successful identification of anatomy
timeFrame: During procedure on data collection date
measure: Subject Questionnaire
timeFrame: During procedure on data collection date
Other outcomes:
Locations:
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
Study officials:
References:
citation: 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.