Ignite Creation Date:
2024-05-06 @ 2:11 PM
Last Modification Date:
2024-10-26 @ 1:26 PM
Study NCT ID:
NCT04242160
Status:
COMPLETED
Last Update Posted:
2020-01-27
First Post:
2020-01-19
Brief Title:
Comparison of Two Resuscitative Thoracotomy Techniques
Sponsor:
Brooke Army Medical Center
Organization:
Brooke Army Medical Center
Study Overview
Official Title:
Prospective Randomized Trial of Standard Left Anterolateral Thoracotomy vs Modified Bilateral Clamshell Thoracotomy Performed by Emergency Physicians
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Londons 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None