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实验性出血中大腿袖带充气的随机交叉研究方案:评估其作为3区REBOA模型的潜力。

Protocol for a randomized crossover study of thigh cuff inflation in experimental hemorrhage: Assessing its potential as a model for zone 3 REBOA.

作者信息

Torbjørnsen Sara Stadskleiv, Lie Sole Lindvåg, Rehn Marius, Hisdal Jonny, Høiseth Lars Øivind

机构信息

Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway.

Section of Vascular Investigations, Heart-, lung- and vascular clinic, Oslo University Hospital, Oslo, Norway.

出版信息

PLoS One. 2025 Jul 28;20(7):e0327404. doi: 10.1371/journal.pone.0327404. eCollection 2025.

DOI:10.1371/journal.pone.0327404
PMID:40720445
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12303282/
Abstract

Resuscitative endovascular balloon occlusion of the aorta (REBOA) is a method to provide temporary control of noncompressible torso hemorrhage in trauma patients. Previous research on REBOA has mainly focused on animals and patients. This study aims to explore whether thigh cuff inflation combined with simulated hemorrhage can serve as an experimental human model for zone 3 REBOA. Lower body negative pressure is a model of hypovolemia. A zone 3 REBOA occludes aorta at its bifurcation, essentially excluding the pelvis and lower extremities from the circulation. Bilateral proximal thigh cuffs will occlude blood vessels to and from the lower extremities. Twenty healthy volunteers will be exposed to bilateral proximal thigh cuff inflation to suprasystolic pressures to simulate the hemodynamic effects of REBOA during experimental hemorrhage using lower body negative pressure (LBNP). Each participant will complete two experimental conditions in a randomized order within one study visit. In the one condition, subjects will undergo only 60 mmHg LBNP for six minutes. In the alternate condition, 60 mmHg LBNP will be applied for six minutes, adding thigh cuff inflation during the final three minutes. Continuous, non-invasive monitoring of systemic hemodynamic parameters-including arterial blood pressure, stroke volume, and heart rate-will be conducted. Cerebral hemodynamics will be assessed by measuring middle cerebral artery blood velocity and cerebral oxygenation. Pain related to thigh cuff inflation will be assessed using a verbal numerical rating scale. The impact of thigh cuff inflation on systemic and cerebral hemodynamics will be evaluated using mixed-effects regression modeling. This study aims to examine the systemic and cerebral hemodynamic effects of combined thigh cuff inflation and lower body negative pressure in healthy volunteers. Based on the feasibility and findings, the potential of this combination as a model for zone 3 REBOA in simulated hemorrhage will be discussed.

摘要

复苏性血管内主动脉球囊阻断术(REBOA)是一种用于临时控制创伤患者不可压缩的躯干出血的方法。先前关于REBOA的研究主要集中在动物和患者身上。本研究旨在探讨大腿袖带充气联合模拟出血是否可作为3区REBOA的人体实验模型。下体负压是一种低血容量模型。3区REBOA在主动脉分叉处阻断主动脉,基本上将骨盆和下肢排除在循环之外。双侧近端大腿袖带将阻断进出下肢的血管。20名健康志愿者将接受双侧近端大腿袖带充气至收缩压以上,以模拟在使用下体负压(LBNP)进行实验性出血期间REBOA的血流动力学效应。每位参与者将在一次研究访问中以随机顺序完成两种实验条件。在一种条件下,受试者仅接受60 mmHg的下体负压,持续6分钟。在另一种条件下,将施加60 mmHg的下体负压6分钟,并在最后三分钟添加大腿袖带充气。将对包括动脉血压、每搏输出量和心率在内的全身血流动力学参数进行连续、非侵入性监测。将通过测量大脑中动脉血流速度和脑氧合来评估脑血流动力学。将使用言语数字评定量表评估与大腿袖带充气相关的疼痛。将使用混合效应回归模型评估大腿袖带充气对全身和脑血流动力学的影响。本研究旨在检查大腿袖带充气联合下体负压对健康志愿者全身和脑血流动力学的影响。基于可行性和研究结果,将讨论这种组合作为模拟出血中3区REBOA模型的潜力。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bc5e/12303282/3921fb25622c/pone.0327404.g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bc5e/12303282/1bb5e86f912f/pone.0327404.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bc5e/12303282/3921fb25622c/pone.0327404.g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bc5e/12303282/1bb5e86f912f/pone.0327404.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bc5e/12303282/3921fb25622c/pone.0327404.g002.jpg

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