Comparison of Two Resuscitative Thoracotomy Techniques

NCT ID: NCT04242160

Last Updated: 2020-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-19

Study Completion Date

2019-03-27

Brief Summary

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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

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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

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Emergencies Trauma Procedural Training Thoracotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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

OTHER

Blinding Strategy

NONE

Study Groups

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Modified Clamshell Thoracotomy First

Participants randomized to perform the MCT first, then cross over to the perform the alternate LAT.

Group Type EXPERIMENTAL

Modified Clamshell Thoracotomy

Intervention Type 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

Intervention Type 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 First

Participants randomized to perform the LAT first, then cross over to the perform the alternate MCT.

Group Type ACTIVE_COMPARATOR

Modified Clamshell Thoracotomy

Intervention Type 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

Intervention Type OTHER

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

Interventions

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Modified Clamshell Thoracotomy

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

Intervention Type OTHER

Left Anterolateral Thoracotomy

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\- unwilling to participate
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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United States Army Institute of Surgical Research

FED

Sponsor Role collaborator

United States Air Force En Route Care Research Center

UNKNOWN

Sponsor Role collaborator

Centre for Emergency Health Sciences

UNKNOWN

Sponsor Role collaborator

Barts & The London NHS Trust

OTHER

Sponsor Role collaborator

The Institute of Pre-Hospital Care at London's Air Ambulance

UNKNOWN

Sponsor Role collaborator

US Air Force 711th Human Performance Wing

UNKNOWN

Sponsor Role collaborator

Brooke Army Medical Center

FED

Sponsor Role lead

Responsible Party

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Derek J Brown, MD

Emergency Medicine Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Brooke Army Medical Center

Fort Sam Houston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 32807537 (View on PubMed)

Other Identifiers

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C.2017.172e

Identifier Type: -

Identifier Source: org_study_id

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