Gastroesophageal Resuscitative Occlusion of the Aorta (GROA)
Abstract
Natural Orifice Transluminal Endoscopic Surgery (NOTES) is an evolving surgical innovation that allows for intra-cavitary (chest, abdomen, and pelvis) surgeries to be performed with an endoscope passed through a natural body opening (mouth anus, vagina, urethra). It is the purpose of this proposal to leverage the concept of NOTES to develop a method of temporary abdominal aortic occlusion using an orally placed gastroesophageal device. This grastroesophageal resuscitative occlusion of the aorta (GROA) will be developed to stop life-threatening intra-abdominal and pelvic hemorrhage as a field bridge to more invasive and definitive means of control of noncompressible hemorrhage such as resuscitative endovascular balloon occlusion of the aorta (REBOA), angiography, and surgery. Hypothesis: The anatomical relationship between the esophagus and stomach to the descending thoracic and abdominal aorta will allow for complete mechanical occlusion of the aorta through the stomach that can prolong short-term survival of severe non-compressible abdominal and pelvic hemorrhage. Specific Aims/Objectives: (1) Design and prototype a GROA device that can be orally placed into stomach and that mechanically allows complete occlusion of the descending aorta near the stomach followed by testing the physiologic tolerance of GROA in comparison to REBOA in swine undergoing hemorrhage. (2) Test and compare GROA prototypes to REBOA for stopping severe noncompressible abdominal hemorrhage in a large swine animal model of traumatic shock. (3) Demonstrate back-to-back use of GROA followed by REBOA as an example of near point-of-care in field prolonged field care (PFC) and prolonged damage control resuscitation (pDCR) in an animal model and severe noncompressible abdominal hemorrhage. Experimental Approach: A back-and-forth design and testing approach will be taken to develop a product that takes advantage of the anatomical relationship of the esophagus and stomach to the descending thoracic and abdominal aorta. A combination of thoracic and abdominal 3-D reconstructed computed tomography (CT) scans across a wide variety of patient body types will be used design the GROA device. Some of this work is based on this group s previous approach using morphomics (various anatomical characteristics) to map the 3-D vascular anatomy of over 2000 individuals in developing new REBOA systems. Computer modeling and simulator testing will be used to understand actual tissue qualities and constraints on design characteristics and tolerances for device components including the development of balloons. A reliance on 3-D printing to produce prototypes will ensure rapid iterative development-refinement of GROA. Preclinical testing using anesthetized swine will also be used to test the effectiveness of the various GROA designs to occlude the aorta. Its effects on the physiology, anatomy, and organ function of the animals will be studied to understand potential complications. Finally, GROA will be compared to traditional REBOA for effectiveness and in experiments allowing for the initial use of GROA to stop bleeding followed by the use of REBOA to simulate a PFC and pDCR situation. The latter will provide proof of feasibility of initial rapid stabilization using GROA followed by transition to the more sophisticated use of REBOA. Alignment with Focus Area and Military/Civilian Benefit: This proposal addresses Focus Area 3 of the Prolonged Field Care Research Award. Focus Area 3 calls for the development of enhanced treatment of injuries during PFC and pDCR, including the development of forward surgical techniques and technologies to stabilized life- and limb-threatening injuries. This includes a call to develop new advanced methods to stop life-threatening bleeding. The proposal is also aligned with Focus Areas 2 and 3 in their call for novel and improved methods of resuscitation and stabilization (including devices) for combined hemorrhagic shoc
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Oct 29, 2018
- Source ID
- W81XWH1810033
Entities
People
- Kevin Ward
Organizations
- United States Army
- University of Michigan