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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04242160
Enrollment
15
Registered
2020-01-27
Start date
2018-11-19
Completion date
2019-03-27
Last updated
2020-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergencies, Procedural Training, Thoracotomy, Trauma

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.

Interventions

OTHERModified Clamshell Thoracotomy

Participants received standardized training on performing a MCT and LAT. Participants then performed the procedures on a fresh human cadaver model.

OTHERLeft Anterolateral Thoracotomy

Participants received standardized training on performing a MCT and LAT. Participants then performed the procedures on a fresh human cadaver model.

Sponsors

United States Army Institute of Surgical Research
CollaboratorFED
United States Air Force En Route Care Research Center
CollaboratorUNKNOWN
Centre for Emergency Health Sciences
CollaboratorUNKNOWN
Barts & The London NHS Trust
CollaboratorOTHER
The Institute of Pre-Hospital Care at London's Air Ambulance
CollaboratorUNKNOWN
US Air Force 711th Human Performance Wing
CollaboratorUNKNOWN
Brooke Army Medical Center
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Intervention model description

Participants were randomized to the order of intervention. After completing the first RT technique assigned, participants complete the alternative RT technique

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

\- unwilling to participate

Design outcomes

Primary

MeasureTime frameDescription
Time to successful completion of RT procedureDuring procedure on data collection dateTime 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

MeasureTime frameDescription
Successful descending thoracic aorta cross-clamp defined as 100% occlusion of the descending aorta with a vascular clampDuring procedure on data collection dateDetermined by General Surgeon observer
Time to delivery of the heart defined as exposure and inspection of all surfacesDuring procedure on data collection datetime 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 clampDuring procedure on data collection datetotal elapsed time from command go to subject verbalizing successful cross-clamping of the descending thoracic aorta
Successful delivery of the heart defined as exposure and inspection of all surfacesDuring procedure on data collection dateDetermined by General Surgeon observer
Successful identification of anatomyDuring procedure on data collection dateSuccessful identification of the phrenic nerve, right atrium, left atrium, right ventricle, left ventricle, pulmonary hilum, descending thoracic aorta, and esophagus.
Subject QuestionnaireDuring procedure on data collection dateProcedural ease, comfort, view, equipment comfort and preference.
Occurrence of iatrogenic injuriesDuring procedure on data collection dateInjury to phrenic nerve, esophagus, lung, heart or other anatomical structure as identified by a General Surgeon AI.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026