PROtocolized care to reduce HYpotension after spinal anaesthesia (ProCRHYSA randomized trial): Study protocol for a randomized controlled trial

Abstract

BackgroundThe 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/DesignAim 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.DiscussionThe 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.ConclusionsThe 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.Trial registrationThe trial was registered on May 2014 on www.clinicalstrial.gov with the number NCT02070276.

Fluid administration guided by inferior vena cava ultrasound before spinal anaesthesia may reduce post procedural hypotension rate

“…Usually, this has mild consequences in healthy patients, often presenting transitory dizziness, nausea or vomiting [7,8], but it can lead to more serious consequences in groups of patients with pulmonary, cardiac and cerebrovascular diseases [4,9]. As previously reported in the literature, the rate of arterial hypotension is around 50% [20];…”

“…From previous studies we estimated the incidence of arterial hypotension after SA to be of about 50% in the control group [20]. In order to have a significant reduction of 10%…”

“…Our trial had some limitations. First, it was not possible to blind patients about group allocation; to overcome this limitation we chose to clearly define all the controlling factors required to describe patient as "hypotensive patient", to avoid any subjective definition [20]. Moreover, to reduce further bias in this setting, the identification of the patient's criteria of arterial hypotension was determined by the software and not by the physician in charge, according to these pre-determined limits [20].…”

“…1). As previously described [20], the subcostal echocardiographic window was evaluated to perform the IVC measurement in spontaneous breathing patients. The IVC collapsibility index (IVC-CI)…”

Cardiac arrest despite optimal preloading of patient using ultrasonography-guided inferior vena cava indices under subarachnoid neuraxial blockade: A report of two cases

“…In tangent with our case series where the USG-guided fluid preloading was done based on the IVC indices under SA, the ongoing (ProCRHYSA randomized trial) is also aimed to study the similar outcome of limiting the hypotension postspinal anesthesia. [ 11 ]…”