Clinical Trials Directory

Trials / Completed

CompletedNCT04242160

Comparison of Two Resuscitative Thoracotomy Techniques

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
15 (actual)
Sponsor
Brooke Army Medical Center · Federal
Sex
All
Age
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERModified Clamshell ThoracotomyParticipants received standardized training on performing a MCT and LAT. Participants then performed the procedures on a fresh human cadaver model.
OTHERLeft Anterolateral ThoracotomyParticipants received standardized training on performing a MCT and LAT. Participants then performed the procedures on a fresh human cadaver model.

Timeline

Start date
2018-11-19
Primary completion
2019-03-27
Completion
2019-03-27
First posted
2020-01-27
Last updated
2020-01-27

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04242160. Inclusion in this directory is not an endorsement.