低血压预测指数指导下的硬膜外分娩镇痛监测的可行性:一项随机对照试验

Feasibility of Hypotension Prediction Index-Guided Monitoring for Epidural Labor Analgesia: A Randomized Controlled Trial.

作者信息

Aloziem Okechukwu, Lin Hsing-Hua Sylvia, Kelly Kourtney, Nicholas Alexandra, Romeo Ryan C, Smith C Tyler, Yu Ximiao, Lim Grace

机构信息

Department of Anesthesiology and Perioperative Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA 15224, USA.

Department of Obstetrics, Gynecology & Reproductive Sciences, University of Pittsburgh School of Medicine, Pittsburgh, PA 15224, USA.

出版信息

J Clin Med. 2025 Jul 16;14(14):5037. doi: 10.3390/jcm14145037.

Abstract

Hypotension following epidural labor analgesia (ELA) is its most common complication, affecting approximately 20% of patients and posing risks to both maternal and fetal health. As digital tools and predictive analytics increasingly shape perioperative and obstetric anesthesia practices, real-world implementation data are needed to guide their integration into clinical care. Current monitoring practices rely on intermittent non-invasive blood pressure (NIBP) measurements, which may delay recognition and treatment of hypotension. The Hypotension Prediction Index (HPI) algorithm uses continuous arterial waveform monitoring to predict hypotension for potentially earlier intervention. This clinical trial evaluated the feasibility, acceptability, and efficacy of continuous HPI-guided treatment in reducing time-to-treatment for ELA-associated hypotension and improving maternal hemodynamics. This was a prospective randomized controlled trial design involving healthy pregnant individuals receiving ELA. Participants were randomized into two groups: Group CM (conventional monitoring with NIBP) and Group HPI (continuous noninvasive blood pressure monitoring). In Group HPI, hypotension treatment was guided by HPI output; in Group CM, treatment was based on NIBP readings. Feasibility, appropriateness, and acceptability outcomes were assessed among subjects and their bedside nurse using the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) instruments. The primary efficacy outcome was time-to-treatment of hypotension, defined as the duration between onset of hypotension and administration of a vasopressor or fluid therapy. This outcome was chosen to evaluate the clinical responsiveness enabled by HPI monitoring. Hypotension is defined as a mean arterial pressure (MAP) < 65 mmHg for more than 1 min in Group CM and an HPI threshold < 75 for more than 1 min in Group HPI. Secondary outcomes included total time in hypotension, vasopressor doses, and hemodynamic parameters. There were 30 patients (Group HPI, n = 16; Group CM, n = 14) included in the final analysis. Subjects and clinicians alike rated the acceptability, appropriateness, and feasibility of the continuous monitoring device highly, with median scores ≥ 4 across all domains, indicating favorable perceptions of the intervention. The cumulative probability of time-to-treatment of hypotension was lower by 75 min after ELA initiation in Group HPI (65%) than Group CM (71%), although this difference was not statistically significant (log-rank = 0.66). Mixed models indicated trends that Group HPI had higher cardiac output (β = 0.58, 95% confidence interval -0.18 to 1.34, = 0.13) and lower systemic vascular resistance (β = -97.22, 95% confidence interval -200.84 to 6.40, = 0.07) throughout the monitoring period. No differences were found in total vasopressor use or intravenous fluid administration. Continuous monitoring and precision hypotension treatment is feasible, appropriate, and acceptable to both patients and clinicians in a labor and delivery setting. These hypothesis-generating results support that HPI-guided treatment may be associated with hemodynamic trends that warrant further investigation to determine definitive efficacy in labor analgesia contexts.

摘要

硬膜外分娩镇痛(ELA)后的低血压是其最常见的并发症,约20%的患者受其影响,对母婴健康均构成风险。随着数字工具和预测分析日益影响围手术期和产科麻醉实践,需要真实世界的实施数据来指导将其整合到临床护理中。当前的监测方法依赖于间歇性无创血压(NIBP)测量,这可能会延迟对低血压的识别和治疗。低血压预测指数(HPI)算法使用连续动脉波形监测来预测低血压,以便可能进行更早的干预。这项临床试验评估了连续HPI指导治疗在减少ELA相关低血压的治疗时间和改善产妇血流动力学方面的可行性、可接受性和有效性。这是一项前瞻性随机对照试验设计,涉及接受ELA的健康孕妇。参与者被随机分为两组:CM组(采用NIBP进行常规监测)和HPI组(连续无创血压监测)。在HPI组中,低血压治疗由HPI输出指导;在CM组中,治疗基于NIBP读数。使用干预措施可接受性(AIM)、干预措施适当性(IAM)和干预措施可行性(FIM)工具对受试者及其床边护士的可行性、适当性和可接受性结果进行评估。主要疗效指标是低血压的治疗时间,定义为低血压发作与使用血管升压药或液体治疗之间的持续时间。选择该指标来评估HPI监测所带来的临床反应性。在CM组中,低血压定义为平均动脉压(MAP)<65 mmHg持续超过1分钟;在HPI组中,低血压定义为HPI阈值<75持续超过1分钟。次要指标包括低血压总时长、血管升压药剂量和血流动力学参数。最终分析纳入了30例患者(HPI组,n = 16;CM组,n = 14)。受试者和临床医生对连续监测设备的可接受性、适当性和可行性评价都很高,所有领域的中位数得分均≥4,表明对该干预措施的看法良好。HPI组在ELA开始后低血压治疗时间的累积概率比CM组低75分钟(65%对71%),尽管这种差异无统计学意义(对数秩检验=0.66)。混合模型显示,在整个监测期间,HPI组有较高心输出量的趋势(β = 0.58,95%置信区间-0.18至1.34,P = 0.13)和较低的全身血管阻力(β = -97.22,95%置信区间-200.84至6.40,P = 0.07)。在血管升压药总使用量或静脉输液方面未发现差异。在分娩环境中,连续监测和精准低血压治疗对患者和临床医生而言都是可行、适当且可接受的。这些产生假设的结果支持,HPI指导治疗可能与血流动力学趋势相关,这值得进一步研究以确定其在分娩镇痛环境中的明确疗效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5e4d/12295593/6468bf906930/jcm-14-05037-g001.jpg

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