Skerrett Erica, Kommwa Edward, Maynard Kelley, Juarez Alexa, Mataya Ronald, Richards-Kortum Rebecca, Oden Z Maria
Rice 360: Institute for Global Health Technologies, Rice University, Houston, TX, USA.
Department of Obstetrics and Gynecology, Queen Elizabeth Central Hospital, Blantyre, Malawi.
BMC Pregnancy Childbirth. 2017 Jun 19;17(1):191. doi: 10.1186/s12884-017-1382-9.
Magnesium sulfate is an affordable and effective treatment for pre-eclampsia and eclampsia. In settings where infusion pumps are not available to regulate the flow rate of intravenous delivery, healthcare providers must administer magnesium sulfate (MgSO) via time-consuming and painful, large-volume intramuscular injections. As an alternative to costly commercially available syringe pumps, we developed AutoSyp, an accurate, low-cost, and low-powered syringe pump designed to meet the needs and constraints these low-resource settings. This paper describes results of a pilot study to evaluate the feasibility of using AutoSyp to administer MgSO intravenously to women suffering from pre-eclampsia at a referral hospital in Blantyre, Malawi.
AutoSyp was programmed to deliver MgSO following the Zuspan regimen to pregnant and post-partum women suffering from pre-eclampsia at Queen Elizabeth Central Hospital in Blatnyre, Malawi. Given the selection of either loading or maintenance dose on AutoSyp's user interface, the flow rate was automatically programmed to dispense 60 mL/h or 5 mL/h of 20% MgSO solution, respectively. During each treatment, the dispensed volume was automatically calculated by the device based on the plunger position and stored on a computer for accuracy analysis of the mean flow rate and total volume delivered. The clinical results for both the loading and maintenance dose administrations were compared to the device's accuracy during tests performed in the laboratory setting.
Twenty-two women were enrolled in this study. In both the clinical and laboratory settings, the mean flow rate errors for the loading and maintenance dose infusions were under 2%. During 466 h of testing, the device sounded 129 occlusion alarms across 14 subjects. Of these, 71 alarms were false positives.
Results of this study support the use of AutoSyp as a less painful and accurate means of MgSO administration in clinical environments that lack infusion systems. There were a large number of false alarms in the current system which will be addressed in future designs. AutoSyp maintains the comfort of intravenous MgSO administration, but unlike commercially available syringe pumps, it is capable of operating with a variety of syringe brands and sizes and requires no additional consumables. AutoSyp's appropriate design will benefit its implementation and sustained use in low-resource settings.
Trial registered prospectively on November 18, 2014 with ClinicalTrials.gov ( NCT02296931 ).
硫酸镁是治疗子痫前期和子痫的一种经济有效的药物。在没有输液泵来调节静脉给药流速的情况下，医疗服务提供者必须通过耗时且痛苦的大剂量肌肉注射来给予硫酸镁（MgSO）。作为昂贵的市售注射泵的替代方案，我们开发了AutoSyp，这是一种精确、低成本且低功耗的注射泵，旨在满足这些资源匮乏地区的需求和限制条件。本文描述了一项试点研究的结果，该研究旨在评估在马拉维布兰太尔的一家转诊医院使用AutoSyp为子痫前期女性静脉注射MgSO的可行性。
对AutoSyp进行编程，以便按照祖斯潘方案为马拉维布兰太尔伊丽莎白女王中央医院患有子痫前期的孕妇和产后妇女输送MgSO。在AutoSyp的用户界面上选择负荷剂量或维持剂量后，流速会自动编程为分别以60毫升/小时或5毫升/小时的速度输注20%的MgSO溶液。在每次治疗过程中，设备会根据活塞位置自动计算输注体积，并存储在计算机上，以便对平均流速和输注总体积进行准确性分析。将负荷剂量和维持剂量给药的临床结果与在实验室环境中进行测试时设备的准确性进行比较。
本研究招募了22名女性。在临床和实验室环境中，负荷剂量和维持剂量输注的平均流速误差均低于2%。在466小时的测试过程中，该设备对14名受试者发出了129次阻塞警报。其中，71次警报为误报。
本研究结果支持在缺乏输液系统的临床环境中使用AutoSyp作为一种痛苦较小且准确的MgSO给药方式。当前系统中存在大量误报，将在未来的设计中加以解决。AutoSyp保持了静脉注射MgSO的舒适性，但与市售注射泵不同的是，它能够与各种品牌和尺寸的注射器配合使用，且无需额外的耗材。AutoSyp的合理设计将有利于其在资源匮乏地区的实施和持续使用。
该试验于2014年11月18日在ClinicalTrials.gov上进行前瞻性注册（NCT02296931）。
