EmergenciesNCT04242160
Comparison of Two Resuscitative Thoracotomy Techniques
A study testing Modified Clamshell Thoracotomy and Left Anterolateral Thoracotomy in people with Emergencies and Trauma, run by Brooke Army Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Emergencies, Trauma, Procedural Training
- What is being tested?
- Modified Clamshell Thoracotomy and Left Anterolateral Thoracotomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2018to 27 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- licensed physician
- emergency medicine residency trainee or graduate
- privileged provider at SAMMC
Who cannot join
- unwilling to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
About this study
Official title: Prospective Randomized Trial of Standard Left Anterolateral Thoracotomy vs Modified Bilateral Clamshell Thoracotomy Performed by Emergency Physicians
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.
Read the 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.
- Conditions
- Emergencies, Trauma, Procedural Training, Thoracotomy
- Being tested
- Modified Clamshell Thoracotomy, Left Anterolateral Thoracotomy
- Medical subject headings
- Emergencies, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Clamshell ThoracotomyOther
Participants received standardized training on performing a MCT and LAT. Participants then performed the procedures on a fresh human cadaver model.
Left Anterolateral ThoracotomyOther
Participants received standardized training on performing a MCT and LAT. Participants then performed the procedures on a fresh human cadaver model.
| Study group | Role | What they receive |
|---|---|---|
| Modified Clamshell Thoracotomy First | Experimental | Participants randomized to perform the MCT first, then cross over to the perform the alternate LAT. Receives: Other: Modified Clamshell Thoracotomy; Other: Left Anterolateral Thoracotomy |
| Left Anterolateral Thoracotomy First | Active comparator | Participants randomized to perform the LAT first, then cross over to the perform the alternate MCT. Receives: Other: Modified Clamshell Thoracotomy; Other: Left Anterolateral Thoracotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During procedure on data collection date
Secondary outcomes (7)
Successful delivery of the heart defined as exposure and inspection of all surfaces
Determined by General Surgeon observer
Measured: During procedure on data collection date
Successful descending thoracic aorta cross-clamp defined as 100% occlusion of the descending aorta with a vascular clamp
Determined by General Surgeon observer
Measured: During procedure on data collection date
Time to delivery of the heart defined as exposure and inspection of all surfaces
time from command "go" to subject verbalizing delivery of heart
Measured: During procedure on data collection date
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
Measured: During procedure on data collection date
Occurrence of iatrogenic injuries
Injury to phrenic nerve, esophagus, lung, heart or other anatomical structure as identified by a General Surgeon AI.
Measured: During procedure on data collection date
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.
Measured: During procedure on data collection date
Subject Questionnaire
Procedural ease, comfort, view, equipment comfort and preference.
Measured: During procedure on data collection date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start19 Nov 2018
- Primary completion27 Mar 2019
- Study completion27 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EmergenciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brooke Army Medical Center
- Sponsor type
- US federal agency
- 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
- Responsible party
- Principal investigator, Derek J Brown, MD, Brooke Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04242160
- Sponsor's protocol ID
- C.2017.172e
- Status last verified
- Jan 2020
- First submitted
- 19 Jan 2020
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32807537
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial of Standard Left Anterolateral Thoracotomy vs Modified Bilateral Clamshell Thoracotomy Performed by Emergency Physicians
- ClinicalTrials.gov ID
- NCT04242160
- Acronym / sponsor ID
- C.2017.172e
- Conditions
- Emergencies, Trauma, Procedural Training, Thoracotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Brooke Army Medical CenterUS federal agency
- 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
- Study start
- 19 Nov 2018 (actual)
- Primary completion
- 27 Mar 2019 (actual)
- Study completion
- 27 Mar 2019 (actual)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomized to the order of intervention. After completing the first RT technique assigned, participants complete the alternative RT technique
| Arm | Type | Receives |
|---|---|---|
| Modified Clamshell Thoracotomy First | Experimental | Other: Modified Clamshell Thoracotomy, Other: Left Anterolateral ThoracotomyParticipants randomized to perform the MCT first, then cross over to the perform the alternate LAT. |
| Left Anterolateral Thoracotomy First | Active comparator | Other: Modified Clamshell Thoracotomy, Other: Left Anterolateral ThoracotomyParticipants randomized to perform the LAT first, then cross over to the perform the alternate MCT. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- licensed physician
- emergency medicine residency trainee or graduate
- privileged provider at SAMMC
Key exclusion criteria (1 listed)
- unwilling to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Clamshell ThoracotomyParticipants received standardized training on performing a MCT and LAT. Participants then performed the procedures on a fresh human cadaver model. | Other | Left Anterolateral Thoracotomy First, Modified Clamshell Thoracotomy First |
| Left Anterolateral ThoracotomyParticipants received standardized training on performing a MCT and LAT. Participants then performed the procedures on a fresh human cadaver model. | Other | Left Anterolateral Thoracotomy First, Modified Clamshell Thoracotomy First |
Primary outcome
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.
7 secondary outcomes
Successful delivery of the heart defined as exposure and inspection of all surfaces
Time frame: During procedure on data collection date
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
Time to delivery of the heart defined as exposure and inspection of all surfaces
Time frame: During procedure on data collection date
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
Occurrence of iatrogenic injuries
Time frame: During procedure on data collection date
Successful identification of anatomy
Time frame: During procedure on data collection date
Subject Questionnaire
Time frame: During procedure on data collection date
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Derived from this study: PubMed 32807537Newberry 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Clamshell Thoracotomy and Left Anterolateral Thoracotomy in people with Emergencies and Trauma, run by Brooke Army Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to successful completion of RT procedure (time frame: During procedure on data collection date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04242160, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.