Trauma Clinical Trial
Official title:
Prospective Randomized Trial of Standard Left Anterolateral Thoracotomy vs Modified Bilateral Clamshell Thoracotomy Performed by Emergency Physicians
Verified date | January 2020 |
Source | Brooke Army Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 15 |
Est. completion date | March 27, 2019 |
Est. primary completion date | March 27, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - licensed physician - emergency medicine residency trainee or graduate - privileged provider at SAMMC Exclusion Criteria: - unwilling to participate |
Country | Name | City | State |
---|---|---|---|
United States | Brooke Army Medical Center | Fort Sam Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Brooke Army Medical Center | Barts & The London NHS Trust, Centre for Emergency Health Sciences, The Institute of Pre-Hospital Care at London's Air Ambulance, United States Air Force En Route Care Research Center, United States Army Institute of Surgical Research, US Air Force 711th Human Performance Wing |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Successful delivery of the heart defined as exposure and inspection of all surfaces | Determined by General Surgeon observer | During procedure on data collection date | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Subject Questionnaire | Procedural ease, comfort, view, equipment comfort and preference. | During procedure on data collection date |
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