Ceruti S, Minotti B, De Vivo S, De Christophoris P, Anselmi L, Saporito A
Department of Intensive Care Medicine, Hôpitaux Universitaires de Genève, Rue Gabrielle-Perret-Gentil 5, 1205 Genève, Switzerland.
Department of Anesthesiology, Ospedale Regionale di Bellinzona, Via Ospedale 12, 6500 Bellinzona, Switzerland.
Contemp Clin Trials Commun. 2016 Jun 29;4:39-45. doi: 10.1016/j.conctc.2016.06.012. eCollection 2016 Dec 15.
The PROtocolized Care to Reduce HYpotension after Spinal Anaesthesia (ProCRHYSA trial) is an unblinded, randomized, monocentric, prospective, three-arm, parallel-group trial aimed at assessing the role of a controlled volemic repletion in reducing both clinically significant hypotension rate and total amount of fluid administered in patients undergoing spinal anaesthesia.
METHODS/DESIGN: Aim of the study is assessing the effectiveness of a non-invasive tests to guide a titrated volemic repletion before spinal anesthesia in order to reduce post-spinal hypotension rate. After local ethical committee approval of the study (Comitato Etico Cantonale Ref. N. CE2796), we will randomize patients undergoing elective surgery under spinal anesthesia into two parallel groups: in the first vena cava ultrasound will be used in order to assess adequacy of patients' volemic status and consequently guide the administration of crystalloids boluses; in the second passive legs raising test will be used instead of ultrasound for the same purpose.
The hypothesis we want to test is that the using of these two experimental methods before spinal anaesthesia, compared to the standard method (empirical fluid administration) can reduce the impact of systemic hypotension through an adequate titrated volemic repletion, avoiding both hypotension and fluid overload. The final purpose is to ensure that spinal anaesthesia is performed in the safest way possible.
The study will offer a new insight on the possible role of vena cava ultrasound and passive legs raising test as screening tools to prevent hypotension after spinal anesthesia. These tests were already validated in a critical environment, but to the best of our knowledge this is the first time they are applied to an elective surgical population.
The trial was registered on May 2014 on www.clinicalstrial.gov with the number NCT02070276.
脊髓麻醉后降低低血压的方案化护理（ProCRHYSA试验）是一项非盲、随机、单中心、前瞻性、三臂、平行组试验，旨在评估控制性容量补充在降低脊髓麻醉患者临床显著低血压发生率和液体总给药量方面的作用。
方法/设计：本研究的目的是评估一种非侵入性测试在脊髓麻醉前指导滴定式容量补充以降低脊髓麻醉后低血压发生率的有效性。在当地伦理委员会批准本研究（州伦理委员会参考号CE2796）后，我们将把接受脊髓麻醉下择期手术的患者随机分为两个平行组：第一组将使用腔静脉超声来评估患者的容量状态是否充足，从而指导晶体液推注的给药；第二组将使用被动抬腿试验代替超声来达到相同目的。
我们想要检验的假设是，与标准方法（经验性液体给药）相比，在脊髓麻醉前使用这两种实验方法可以通过适当的滴定式容量补充来降低全身性低血压的影响，避免低血压和液体过载。最终目的是确保以尽可能安全的方式实施脊髓麻醉。
本研究将为腔静脉超声和被动抬腿试验作为预防脊髓麻醉后低血压的筛查工具的可能作用提供新的见解。这些测试已在危急环境中得到验证，但据我们所知，这是它们首次应用于择期手术人群。
该试验于2014年5月在www.clinicalstrial.gov上注册，编号为NCT02070276。
