背景:用于分娩镇痛的程序间歇性硬膜外推注(PIEB)泵需要三种设置:PIEB下推注(PIEBnb),PIEB间隔(PIEBi),和PIEB卷(PIEBv)。这些参数的理想设置仍然未知。我们假设了一个数学建模工具,响应面法(RSM),可以估计3个PIEB泵参数,同时平衡3个临床重要的患者结局。研究目的是使用RSM来估计PIEB设置(PIEBnb,PIEBi,和PIEBv),同时最大限度地提高产妇满意度,最大限度地减少对临床医生给予的推注的需求,并同时优化患者自控硬膜外镇痛(PCEA)推注的比例。
方法:经机构伦理批准,一项双盲随机试验在三级护理产程和分娩中心完成.未产,讲英语的美国麻醉医师协会(ASA)的身体状况II患者年龄18至45岁,顶点表示中的单个妊娠,包括自发分娩和≤7cm宫颈扩张。有合并症的患者,神经轴镇痛的禁忌症,使用慢性镇痛药,<152厘米,或体重指数(BMI)>45kg/m2被排除。知情同意后,分娩镇痛开始使用0.2%罗哌卡因10mL和芬太尼10µg/mL溶液和PCEA(体积每10分钟6mL).将患者随机分配至预定的PIEB设置。RSM确定了3个泵设置,这些泵设置表示同时最大或最小3个结果的固定点:PCEA比率(最接近1的比率),临床医生推注(最佳为0),和产妇满意度(视觉模拟量表,0-100,理想反应≥90)。
结果:在287名潜在参与者中,192不符合入选标准或拒绝参加,26人被撤回,将69名患者纳入研究。使用RSM,所有主要研究结果的建议PIEB设置如下:PIEBnb=29.4分钟,PIEBi=59.8分钟,和PIEBv=6.2mL。这些PIEB设置对应于以下临床结果:产妇满意度为93.9%,PCEA比率为0.77,需要临床医生推注为0.29。89%的患者的皮肤感觉评分在T10和T5之间。中位最低Bromage评分为4分。
结论:这项新的研究使用数学模型来估计PIEB泵设置,同时最大化3个临床结果。同等加权的临床结果阻碍了最大结果优化,并且可能无法反映患者的优先级。未来的研究或质量改进工作可以使用RSM方法来估计PIEB泵设置,以确定对产妇重要的单一临床结果的最佳值为目标。
BACKGROUND: Three settings are required on a programmed intermittent epidural bolus (PIEB) pump for labor analgesia: the PIEB next bolus (PIEBnb), PIEB interval (PIEBi), and PIEB volume (PIEBv). The ideal settings for these parameters are still unknown. We hypothesized a mathematical modeling tool, response surface methodology (RSM), could estimate 3 PIEB pump parameters while balancing 3 clinically important patient outcomes simultaneously. The study objective was to use RSM to estimate PIEB settings (PIEBnb, PIEBi, and PIEBv) while maximizing maternal satisfaction, minimizing the need for clinician-administered boluses, and optimizing the ratio of delivered/requested patient-controlled epidural analgesia (PCEA) boluses simultaneously.
METHODS: With institutional ethics approval, a double-blind randomized trial was completed in a tertiary care labor and delivery center. Nulliparous, English-speaking American Society of Anesthesiologists (ASA) physical status II patients aged 18 to 45 years at full term, single gestation in vertex presentation, in spontaneous labor and ≤7 cm cervical dilation were included. Patients with comorbidities, contraindications to neuraxial analgesia, using chronic analgesics, <152 cm, or body mass index (BMI) >45 kg/m 2 were excluded. After informed consent, labor analgesia was initiated using 10 mL ropivacaine 0.2% with 10 µg/mL fentanyl solution and PCEA (volume 6 mL every 10 minutes). Patients were randomized to predetermined PIEB settings. RSM identified 3 pump settings that represented a stationary point that best maximized or minimized 3 outcomes simultaneously: PCEA ratio (a ratio closest to 1), clinician bolus (optimal is 0), and maternal satisfaction (visual analog scale, 0-100, ideal response is ≥90).
RESULTS: Of 287 potential participants, 192 did not meet inclusion criteria or declined to participate, and 26 were withdrawn, leaving 69 patients for study inclusion. Using RSM, the suggested PIEB settings for all the primary study outcomes were as follows: PIEBnb = 29.4 minutes, PIEBi = 59.8 minutes, and PIEBv = 6.2 mL. These PIEB settings corresponded to the following clinical outcomes: maternal satisfaction at 93.9%, PCEA ratio at 0.77, and need for clinician bolus at 0.29. The dermatome sensory score was between T10 and T5 in 89% of the patients. The median lowest Bromage score was 4.
CONCLUSIONS: This novel study used a mathematical model to estimate PIEB pump settings while simultaneously maximizing 3 clinical outcomes. Equally weighted clinical outcomes prevent maximal outcome optimization and may not reflect patient priorities. Future studies or quality improvement endeavors could use RSM methodology to estimate PIEB pump settings targeting optimal values for a single clinical outcome of determined importance to parturients.