Comparison of Two Resuscitative Thoracotomy Techniques

Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04242160
• Other study ID #: C.2017.172e
• Status: Completed
• Phase: N/A
• Start date: November 19, 2018
• Est. completion date: March 27, 2019

Study information

• Verified date: January 2020
• Source: Brooke Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Emergencies
• Procedural Training
• Thoracotomy
• Trauma

Intervention

Other:
• Modified Clamshell Thoracotomy
Participants received standardized training on performing a MCT and LAT. Participants then performed the procedures on a fresh human cadaver model.
• Left Anterolateral Thoracotomy
Participants received standardized training on performing a MCT and LAT. Participants then performed the procedures on a fresh human cadaver model.

Locations

Country	Name	City	State
United States	Brooke Army Medical Center	Fort Sam Houston	Texas

Sponsors (7)

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

Country where clinical trial is conducted

United States, 

Outcome

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