Comparison of Two Resuscitative Thoracotomy Techniques
Primary Purpose
Emergencies, Trauma, Procedural Training
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Modified Clamshell Thoracotomy
Left Anterolateral Thoracotomy
Sponsored by
About this trial
This is an interventional other trial for Emergencies
Eligibility Criteria
Inclusion Criteria:
- licensed physician
- emergency medicine residency trainee or graduate
- privileged provider at SAMMC
Exclusion Criteria:
- unwilling to participate
Sites / Locations
- Brooke Army Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Modified Clamshell Thoracotomy First
Left Anterolateral Thoracotomy First
Arm Description
Participants randomized to perform the MCT first, then cross over to the perform the alternate LAT.
Participants randomized to perform the LAT first, then cross over to the perform the alternate MCT.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Successful delivery of the heart defined as exposure and inspection of all surfaces
Determined by General Surgeon observer
Successful descending thoracic aorta cross-clamp defined as 100% occlusion of the descending aorta with a vascular clamp
Determined by General Surgeon observer
Time to delivery of the heart defined as exposure and inspection of all surfaces
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
total elapsed time from command "go" to subject verbalizing successful cross-clamping of the descending thoracic aorta
Occurrence of iatrogenic injuries
Injury to phrenic nerve, esophagus, lung, heart or other anatomical structure as identified by a General Surgeon AI.
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.
Subject Questionnaire
Procedural ease, comfort, view, equipment comfort and preference.
Full Information
NCT ID
NCT04242160
First Posted
January 19, 2020
Last Updated
January 22, 2020
Sponsor
Brooke Army Medical Center
Collaborators
United States Army Institute of Surgical Research, United States Air Force En Route Care Research Center, Centre for Emergency Health Sciences, Barts & The London NHS Trust, The Institute of Pre-Hospital Care at London's Air Ambulance, US Air Force 711th Human Performance Wing
1. Study Identification
Unique Protocol Identification Number
NCT04242160
Brief Title
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
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
November 19, 2018 (Actual)
Primary Completion Date
March 27, 2019 (Actual)
Study Completion Date
March 27, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brooke Army Medical Center
Collaborators
United States Army Institute of Surgical Research, United States Air Force En Route Care Research Center, Centre for Emergency Health Sciences, Barts & The London NHS Trust, The Institute of Pre-Hospital Care at London's Air Ambulance, US Air Force 711th Human Performance Wing
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergencies, Trauma, Procedural Training, Thoracotomy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Modified Clamshell Thoracotomy First
Arm Type
Experimental
Arm Description
Participants randomized to perform the MCT first, then cross over to the perform the alternate LAT.
Arm Title
Left Anterolateral Thoracotomy First
Arm Type
Active Comparator
Arm Description
Participants randomized to perform the LAT first, then cross over to the perform the alternate MCT.
Intervention Type
Other
Intervention Name(s)
Modified Clamshell Thoracotomy
Intervention Description
Participants received standardized training on performing a MCT and LAT. Participants then performed the procedures on a fresh human cadaver model.
Intervention Type
Other
Intervention Name(s)
Left Anterolateral Thoracotomy
Intervention Description
Participants received standardized training on performing a MCT and LAT. Participants then performed the procedures on a fresh human cadaver model.
Primary Outcome Measure Information:
Title
Time to successful completion of RT procedure
Description
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.
Time Frame
During procedure on data collection date
Secondary Outcome Measure Information:
Title
Successful delivery of the heart defined as exposure and inspection of all surfaces
Description
Determined by General Surgeon observer
Time Frame
During procedure on data collection date
Title
Successful descending thoracic aorta cross-clamp defined as 100% occlusion of the descending aorta with a vascular clamp
Description
Determined by General Surgeon observer
Time Frame
During procedure on data collection date
Title
Time to delivery of the heart defined as exposure and inspection of all surfaces
Description
time from command "go" to subject verbalizing delivery of heart
Time Frame
During procedure on data collection date
Title
Time to descending thoracic aorta cross clamp defined as 100% occlusion of the descending aorta with a vascular clamp
Description
total elapsed time from command "go" to subject verbalizing successful cross-clamping of the descending thoracic aorta
Time Frame
During procedure on data collection date
Title
Occurrence of iatrogenic injuries
Description
Injury to phrenic nerve, esophagus, lung, heart or other anatomical structure as identified by a General Surgeon AI.
Time Frame
During procedure on data collection date
Title
Successful identification of anatomy
Description
Successful identification of the phrenic nerve, right atrium, left atrium, right ventricle, left ventricle, pulmonary hilum, descending thoracic aorta, and esophagus.
Time Frame
During procedure on data collection date
Title
Subject Questionnaire
Description
Procedural ease, comfort, view, equipment comfort and preference.
Time Frame
During procedure on data collection date
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
licensed physician
emergency medicine residency trainee or graduate
privileged provider at SAMMC
Exclusion Criteria:
- unwilling to participate
Facility Information:
Facility Name
Brooke Army Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32807537
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.
Results Reference
derived
Learn more about this trial
Comparison of Two Resuscitative Thoracotomy Techniques
We'll reach out to this number within 24 hrs