BackgroundResuscitative endovascular balloon occlusion of the aorta (REBOA) is an emerging technique used for non-compressible torso hemorrhage. However, its current use continues to be limited and there is a need for a simple, fast, and low profile REBOA device. Our objective was to evaluate the feasibility of a novel 4 French REBOA device called the COBRA-OS (Control of Bleeding, Resuscitation, Arterial Occlusion System).MethodsThis study is the first-in-human feasibility trial of the COBRA-OS. Due to the difficulty of trialing the device in the trauma setting, we performed a feasibility study using organ donors (due to the potential usefulness of the COBRA-OS for normothermic regional perfusion) after neurological determination of death (NDD) prior to organ retrieval. Bilateral 4 French introducer sheaths were placed in both femoral arteries and the COBRA-OS was advanced up the right side and deployed in the thoracic aorta (Zone 1). Once aortic occlusion was confirmed via the left-sided arterial line, the device was deflated, moved to the infrarenal aorta (Zone 3), and redeployed.ResultsA total of 7 NDD organ donors were entered into the study, 71% men, with a mean age 46.6 years (range 26 to 64). The COBRA-OS was able to occlude the aorta in Zones 1 and 3 in all patients. The mean time of placing a 4 French sheath was 47.7 seconds (n=13, range 28 to 66 seconds). The mean time from skin to Zone 1 aortic occlusion was 70.1 seconds (range 58 to 105 seconds); mean balloon volumes were 15 mL for Zone 1 (range 13 to 20 mL) and 9 mL for Zone 3 (range 6 to 15 mL); there were no complications and visual inspection of the aorta in all patients revealed no injury.DiscussionThe COBRA-OS is a novel 4 French REBOA device that has demonstrated fast and safe aortic occlusion in this first-in-human feasibility study.Level of evidenceLevel V, therapeutic.
Background: REBOA is an emerging technique in trauma. However, inadvertent iliac artery balloon inflation can lead to complications. This study aims to investigate the safety characteristics of the COBRA-OS™ compared to a 7 Fr commercially available device during purposeful iliac artery balloon overinflation.
Methods: In vitro: the COBRA-OS™ was inflated in explanted porcine iliac arteries and intentionally overinflated until balloon or vessel rupture occurred. In vivo: the COBRA-OS™ and 7 Fr device were deployed in the iliac arteries and intentionally overinflated until rupture of the balloon or blood vessel.
Results: In vitro: an average volume of 1mL was required for occlusion using the COBRA-OS™ and the mean balloon rupture volume was 32.5mL. The COBRA-OS™ partially migrated into the aorta in all cases. In vivo: the COBRA-OS™ and 7 Fr device occluded the iliac arteries with a mean volume of 3.5 mL. Overinflation resulted in no iliac ruptures with the COBRA-OS™ (mean balloon rupture volume = 10mL). Overinflation with the 7 Fr device resulted in 1 iliac rupture at 5mL. The other two 7 Fr devices had a mean balloon rupture volume of 5 mL. All COBRA-OS™ devices moved partially up into the aorta during inflation while all 7 Fr devices remained in the iliac artery.
Conclusions: The COBRA-OS™ allows for significant overinflation when deployed in the common iliac artery of a porcine model due to its unique design. This ultimately may help to prevent balloon and blood vessel rupture during clinical use, however further studies are required.
Background:In situ simulation shows promise as an effective training tool for trauma; however, its disruptive nature is a major downside. Although the benefits of in situ simulation in trauma have been described, the potential perceived harms of running an unscheduled simulation using working staff are unknown. The aim of this study is to assess trauma team members' perceptions regarding the value of in situ simulation relative to its perceived impact on patient care. Methods: We conducted a longitudinal survey study including all members of the multidisciplinary trauma team at the Halifax Infirmary, a level 1 trauma centre in Nova Scotia. Following an in situ simulation, participants were given a 10-question survey with answers on a 5-point Likert scale. Results: A total of 61 surveys were collected. Survey respondents were grouped into allied health (nurses, paramedics, respiratory therapists; 44%), learners (residents and medical students; 44%) and other (staff physicians, those who did not specify their role; 12%). Respondents felt that participating in the in situ simulation delayed (28%) or compromised patient care (5%) infrequently. No respondents felt that patients were harmed. In situ simulation was felt to identify important safety issues (70%), improve trauma team communication (89%) and improve trauma patient care (89%). The in situ simulation was considered enjoyable (92%) and was identified as a good educational experience (95%). It was felt by participants that simulations should continue to be done in situ in the trauma bay rather than in a sim laboratory (54%).
Conclusion:The trauma in situ simulation program at the Halifax Infirmary is not felt to cause delays or compromise patient care. The program is considered to be a good learning opportunity that identifies safety issues and improves patient care.
Epidemiology of submersion injuries inCanadian children and adolescents: 1990-2018.
BackgroundThere are a variety of devices capable of performing resuscitative endovascular balloon occlusion of the aorta (REBOA), with most containing compliant balloon material. While compliant material is ideal for balloon inflation due to its “cushioning” effect, it can be problematic to “control” during deflation. The COBRA-OS (Control Of Bleeding, Resuscitation, Arterial Occlusion System) was designed to optimize inflation and deflation of its compliant balloon and was tested in vitro and in vivo with respect to its overinflation and partial REBOA abilities.MethodsFor overinflation, the COBRA-OS was inflated in three differently sized inner diameter (ID) vinyl tubes until balloon rupture. It was then overinflated in six harvested swine aortas and in all three REBOA zones of three anesthetized swine. For partial REBOA, the COBRA-OS underwent incremental deflation in a pulsatile benchtop aortic model and in zone 1 of three anesthetized swine.ResultsFor overinflation, compared with the known aortic rupture threshold of 4 atm, the COBRA-OS exceeded this value in only the smallest of the vinyl tubes: 8 mm ID tube, 6.5 atm; 9.5 mm ID tube, 3.5 atm; 13 mm ID tube, 1.5 atm. It also demonstrated greater than 500% overinflation ability without aortic damage in vitro and caused no aortic damage when inflated to maximum inflation volume in vivo. For partial REBOA, the COBRA-OS was able to provide a titration window of between 3 mL and 4 mL in both the pulsatile vascular model (3.4±0.12 mL) and anesthetized swine (3.8±0.35 mL).DiscussionThe COBRA-OS demonstrated the ability to have a cushioning effect during inflation combined with titration control on deflation in vitro and in vivo. This study suggests that despite its balloon compliance, both safe overinflation and partial REBOA can be successfully achieved with the COBRA-OS.Level of evidenceBasic science.
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