Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04242160
Other study ID # C.2017.172e
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT04848376 - Post-Market Clinical Follow-up Study of A-SPINE's Products
Terminated NCT03781817 - Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children With Non-operative Fractures Phase 4
Completed NCT04342416 - Using a Brief Visuospatial Interference Intervention to Reduce Intrusive Memories Among Trauma Exposed Women N/A
Recruiting NCT04856449 - DBT Skills Plus EMDR for BPD and Trauma N/A
Completed NCT04356963 - Adjunct VR Pain Management in Acute Brain Injury N/A
Completed NCT05669313 - The Effects of Hypothermia and Acidosis on Coagulation During Treatment With Rivaroxaban Measured With ROTEM
Active, not recruiting NCT03622632 - Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association
Recruiting NCT04725721 - Testing FIRST in Youth Outpatient Psychotherapy N/A
Active, not recruiting NCT05530642 - An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel N/A
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Not yet recruiting NCT03696563 - FreeO2 PreHospital - Automated Oxygen Titration vs Manual Titration According to the BLS-PCS N/A
Withdrawn NCT03249129 - Identification of Autoantibodies and Autoantigens in the Cerebrospinal Fluid of Patients With Spinal Cord Trauma
Completed NCT02240732 - Surgical Tourniquets and Cerebral Emboli N/A
Completed NCT02227979 - Effects of PURPLE Cry Intervention N/A
Withdrawn NCT01169025 - Fentanyl vs. Low-Dose Ketamine for the Relief of Moderate to Severe Pain in Aeromedical Patients N/A
Recruiting NCT01812941 - Evaluation of Mitochondrial Dysfunction in Severe Burn and Trauma Patients N/A
Completed NCT01475344 - Fibrinogen Concentrate (FGTW) in Trauma Patients, Presumed to Bleed (FI in TIC) Phase 1/Phase 2
Completed NCT03112304 - Child STEPS for Youth Mental Health in Maine Sustainability N/A
Completed NCT01210417 - Trauma Heart to Arm Time N/A
Completed NCT01201863 - Neuroendocrine Dysfunction in Traumatic Brain Injury: Effects of Testosterone Therapy Phase 4