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Non-invasive Monitoring of hemodynamic status in preterm infants:a prospective comparison of 3 different approaches including feasibility, reproducibility and association to relevant clinical short term outcome

早产儿血流动力学状态的无创监测：对 3 种不同方法的前瞻性比较，包括可行性、可重复性以及与相关临床短期结果的关联

基本信息

批准号：
420536451
负责人：
Dr. Christoph Schwarz
金额：
--
依托单位：
Abteilung IV: Neonatologie
依托单位国家：
德国
项目类别：
Research Fellowships
财政年份：
2018
资助国家：
德国
起止时间：
2017-12-31 至 2020-12-31
项目状态：
已结题

来源：
https://gepris.dfg.de/gepris/projekt/420536451?language=en
关键词：
Non invasive Monitoring hemodynamic status

项目摘要

Background:Understanding neonatal hemodynamics is key to neonatal care and neuroprotection. Despite decades of research, uncertainty continues as to how to continuously monitor hemodynamics in extremely preterm infants. Blood flow is mainly dependent on two key factors: blood pressure (BP) and vascular resistance (and the presence of neonatal shunts). It is still common practice to focus only on BP, thus neglecting the complex and dynamic (patho)physiology that may be present in newborn infants. Thus, in infants with low blood pressure, flow (and hence oxygen delivery) or its surrogate parameter cardiac output, can still be normal in cases of low systemic vascular resistance. Non-invasive cardiac output (CO) monitoring, cerebral regional oxygenation (Near-infrared spectroscopy, NIRS) and pulsatility index monitoring (PI, pulse oxymetry) may have the potential to support routine hemodynamic monitoring of BP and heart rate with additional information.Methods: We intend to perform a prospective observational trial in 100 preterm infants born at Cork University Maternity Hospital (birth rate of almost 8000 babies in 2016) <32 weeks’ gestation during the first 48 postnatal hours. This study consists of 2 parts:1. feasibility and reproducibility: to ensure CO monitoring using electrical cardiometry (Osypka Medical, Berlin, Germany) is safe and reliable (20 infants).2. (main study) prediction of circulatory failure by non-invasive hemodynamic monitoring (80 additional infants).Outcome Variables:For feasibility:The proportion of infants in whom a continuous recording of CO by electrical cardiometry and PI analysis was obtained for at least 24 hours during the first 48 hours after birth.For reproducibility:CO-monitoring and echocardiography (i.e. left ventricular output).Main study: Prediction of circulatory failureDependent variable: Adverse outcome (Yes/No), where an adverse outcome is defined as a cranial ultrasound abnormality or death within 7 days of birth.Independent variables: Onset and proportion of time infants are suspected to have impaired hemodynamics as defined by clinical suspicion (i.e. skin colour, capillary refill time>3s), laboratory parameters (i.e. lactic acidosis), BP, PI analysis, NIRS or CO measures and combination of these measures.Aim:The principle objective of this study is to determine the impact of different continuous hemodynamic monitoring methods and to establish non-invasive hemodynamic monitoring methods in preterm infants within 48 hours of birth. These data may result in more precise definitions of arterial hypotension and permissive hypotension, thus providing data for an evidence based algorithm to assess hemodynamic status in preterm infants.

背景：了解新生儿血流动力学是新生儿护理和神经保护的关键。尽管进行了数十年的研究，但如何持续监测极早产儿的血流动力学仍存在不确定性。血流量主要取决于两个关键因素：血压（BP）和血管阻力（以及新生儿分流的存在）。通常的做法仍然是只关注BP，从而忽视了新生儿可能存在的复杂和动态（病理）生理学。因此，在具有低血压的婴儿中，在低全身血管阻力的情况下，流量（以及因此氧气输送）或其替代参数心输出量仍然可以是正常的。无创心输出量（CO）监测、脑局部氧合（近红外光谱，NIRS）和脉动指数监测（PI，脉搏血氧仪）可能有可能支持常规血液动力学监测血压和心率的额外信息。方法：我们打算在科克大学妇产医院出生的100名早产儿中进行一项前瞻性观察试验（2016年近8000名婴儿的出生率）在出生后的前48小时内，妊娠期<32周。本研究分为两部分：1.可行性和再现性：确保使用心电图（Osypka Medical，柏林，德国）进行的CO监测安全可靠（20名婴儿）。(main无创血流动力学监测预测循环衰竭结果变量：可行性：在出生后的前48小时内，通过心电图和PI分析连续记录CO至少24小时的婴儿比例。主要研究：循环衰竭的预测因变量：不良结局（是/否），其中不良结局定义为出生后7天内的颅脑超声异常或死亡。自变量：根据临床怀疑定义，婴儿疑似血流动力学受损的发作时间和比例（即皮肤颜色、毛细血管再充盈时间>3s）、实验室参数（即乳酸酸中毒）、BP、PI分析、NIRS或CO测量以及这些测量的组合。本研究的主要目的是确定不同连续血流动力学监测方法的影响，并建立出生后48小时内早产儿的无创血流动力学监测方法。这些数据可能导致更精确的动脉低血压和允许性低血压的定义，从而为基于证据的算法提供数据，以评估早产儿的血流动力学状态。