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Completed

NCT Number: NCT04242160

Comparison of Two Resuscitative Thoracotomy Techniques

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.

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Key information

Conditions

Emergencies Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Procedural Training Thoracotomy Trauma Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • unwilling to participate

Treatment and study plan

Modified Clamshell Thoracotomy

Other

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

Left Anterolateral Thoracotomy

Other

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

Primary outcomes

  1. Time to successful completion of RT procedure

    Time frame: During procedure on data collection date

    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 outcomes

  1. Successful delivery of the heart defined as exposure and inspection of all surfaces

    Time frame: During procedure on data collection date

    Determined by General Surgeon observer

  2. Successful descending thoracic aorta cross-clamp defined as 100% occlusion of the descending aorta with a vascular clamp

    Time frame: During procedure on data collection date

    Determined by General Surgeon observer

  3. Time to delivery of the heart defined as exposure and inspection of all surfaces

    Time frame: During procedure on data collection date

    time from command "go" to subject verbalizing delivery of heart

  4. Time to descending thoracic aorta cross clamp defined as 100% occlusion of the descending aorta with a vascular clamp

    Time frame: During procedure on data collection date

    total elapsed time from command "go" to subject verbalizing successful cross-clamping of the descending thoracic aorta

  5. Occurrence of iatrogenic injuries

    Time frame: During procedure on data collection date

    Injury to phrenic nerve, esophagus, lung, heart or other anatomical structure as identified by a General Surgeon AI.

  6. Successful identification of anatomy

    Time frame: During procedure on data collection date

    Successful identification of the phrenic nerve, right atrium, left atrium, right ventricle, left ventricle, pulmonary hilum, descending thoracic aorta, and esophagus.

  7. Subject Questionnaire

    Time frame: During procedure on data collection date

    Procedural ease, comfort, view, equipment comfort and preference.

Sponsors and collaborators

Lead sponsor

Brooke Army Medical Center

Fed

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 27, 2020
Registry last updated
Jan 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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