Accuracy and Precision of the SynchroMed II Pump
Accuracy and Precision of the SynchroMed II Pump
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DOI：
10.1111/ner.12934
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发表时间：
2019-10-01
期刊：
影响因子：
2.8
通讯作者：
Murdock, Fred
中科院分区：
文献类型：
--
作者：
Farid, Reza;Binz, Kirstin;Murdock, Fred
目的评价SynchroMed II程控输液泵鞘内注射巴氯芬治疗重度痉挛的准确性和精密度。设计回顾性病历审查研究。城市学术康复诊所。患者（或参与者）用鞘内巴氯芬治疗痉挛的患者。方法或干预（或风险因素评估）对149例患者（包括755例接受巴氯芬泵再填充超过2.5年的个体患者）进行了回顾性病历审查。对主要结果测量图表进行了审查，以获得有关鞘内巴氯芬浓度和剂量、抽吸量和残留量、泵的使用年限和泵的储液器容量的数据。计算每次按时间顺序访视的流速（mL/天）。根据20 mL和40 mL泵的制造商质量标准，使用临床数据中的流速计算准确度和精密度。结果20 mL和40 mL泵的输注量准确度和精密度均在制造商的规格范围内，而输注速率略低于预期。无泵过度输注病例。在泵的使用寿命内，流速精度在统计学上显著降低。结论SynchroMed II泵的输注速率略低于其预测速率，同时仍符合制造商的规格。未观察到泵过度输注。泵流速随时间下降。需要进一步研究以评估流速降低对患者治疗和安全性的影响。
Objective The objective of this study was to evaluate the accuracy and precision of SynchroMed II programmable infusion pumps for delivery of intrathecal baclofen to treat severe spasticity. Design Retrospective chart review study. Setting Urban academic rehabilitation clinic. Patients (or Participants) Patients with spasticity treated with intrathecal baclofen. Methods or Interventions (or Assessment of Risk Factors) A retrospective chart review of 149 patients inclusive of 755 individual patient encounters more than a 2.5-year span for baclofen pump refills was performed. Main Outcome Measurements Charts were reviewed to obtain data on the concentration and dose of intrathecal baclofen, aspirated and residual volumes, age of the pump, and reservoir volume of the pump. Flow rate (mL/day) was calculated for each chronological visit. Flow rates from clinical data were used to calculate the accuracy and precision based on the manufacturer's specifications for both the 20 mL and 40 mL pumps. Results The infused volume accuracy and precision of both the 20 mL pumps and 40 mL pumps remained within manufacturer's specifications while delivering drug at a rate slightly lower than predicted. There were no cases of pump over-infusion. There is a statistically significant decrease in flow rate accuracy over the lifespan of the pump. Conclusions SynchroMed II pumps infuse at slightly less than their predicted rate while remaining within the manufacturer's specifications. No pump over-infusions were noted. Pump flow rate declines over time. Further study is warranted to assess the impact of this flow rate decrease on patient treatment and safety.