Extracorporeal Circulation

体外循环
  • 文章类型: Journal Article
    背景:对于微创体外循环(MiECC)是否代表当代临床实践中的最佳灌注技术这一问题的最终答案仍然难以捉摸。本研究是一项真实世界的研究,重点关注心脏手术后特定灌注相关的临床结果,这些结果可能会受到MiECC的有利影响,从而影响未来的临床实践。
    方法:MiECS研究是一项国际性的,多中心,双臂随机对照试验。接受择期或紧急冠状动脉旁路移植术(CABG)的患者,使用体外循环的主动脉瓣置换术(AVR)或联合手术(CABGAVR)将被随机分配到MiECC或当代常规体外循环(cCPB)。使用优化的常规电路作为控制是可接受的。研究设计包括一系列防止偏倚的功能,并在clinicaltrials.gov(NCT05487612)上注册。
    结果:主要结局是术后严重不良事件的复合,这些不良事件可能与术后30天发生的灌注技术有关。次要结果包括使用血液制品,ICU和住院时间(30天)以及与健康相关的生活质量(30天和90天)。
    结论:MiECS试验旨在克服先前MiECC试验的局限性。拟议研究的结果可能会影响当前的灌注实践,以促进患者护理。
    BACKGROUND: The ultimate answer to the question whether minimal invasive extracorporeal circulation (MiECC) represents the optimal perfusion technique in contemporary clinical practice remains elusive. The present study is a real-world study that focuses on specific perfusion-related clinical outcomes after cardiac surgery that could potentially be favourably affected by MiECC and thereby influence the future clinical practice.
    METHODS: The MiECS study is an international, multi-centre, two-arm randomized controlled trial. Patients undergoing elective or urgent coronary artery bypass grafting (CABG), aortic valve replacement (AVR) or combined procedure (CABG + AVR) using extracorporeal circulation will be randomized to MiECC or contemporary conventional cardiopulmonary bypass (cCPB). Use of optimized conventional circuits as controls is acceptable. The study design includes a range of features to prevent bias and is registered at clinicaltrials.gov (NCT05487612).
    RESULTS: The primary outcome is a composite of postoperative serious adverse events that could be related to perfusion technique occurring up to 30 days postoperatively. Secondary outcomes include use of blood products, ICU and hospital length of stay (30 days) as well as health-related quality of life (30 and 90 days).
    CONCLUSIONS: The MiECS trial has been designed to overcome perceived limitation of previous trials of MiECC. Results of the proposed study could affect current perfusion practice towards advancement of patient care.
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  • 文章类型: Journal Article
    背景:体外循环引起全身炎症反应,这可能导致术后血流动力学不稳定和终末器官功能障碍。本研究旨在探讨微创体外循环(MiECC)与常规体外循环(CECC)相比对全身炎症反应的影响。
    方法:接受冠状动脉旁路移植术的患者随机分为MiECC(n=30)和CECC(n=30)。主要终点为肿瘤坏死因子-α。次要终点是炎症的其他生化标志物(IL1β,IL6和IL8,C反应蛋白,白细胞),以及组织灌注不足和组织损伤的标志物(乳酸脱氢酶,乳酸和肌酸激酶-MB)。此外,我们记录了全身炎症反应综合征的迹象,血流动力学不稳定,心房颤动,呼吸功能障碍,和感染。
    结果:接受MiECC治疗的患者在体外循环期间和体外循环后早期的肿瘤坏死因子-α水平明显低于CECC(中位数:MiECC3.4pg/mL;CI2.2-4.5vs.CECC4.6pg/mL;CI3.4-5.6;p=0.01)。较低水平的肌酸激酶-MB和乳酸脱氢酶表明组织损伤较小。然而,我们没有检测到其他炎症标志物的显著差异,组织损伤或任何临床结果。
    结论:与CECC相比,MiECC后TNF-α水平降低可能反映了炎症反应降低,尽管其他炎症生化标志物具有可比性。我们的结果表明,与CECC相比,MiECC具有更好的末端器官保护作用。在这项研究中,与全身炎症反应相关的临床参数具有可比性。
    背景:NCT03216720。
    BACKGROUND: Extracorporeal circulation causes a systemic inflammatory response, that may cause postoperative haemodynamic instability and end-organ dysfunction. This study aimed to investigate the impact of minimal invasive extracorporeal circulation (MiECC) on the systemic inflammatory response compared with conventional extracorporeal circulation (CECC).
    METHODS: Patients undergoing coronary artery bypass grafting were randomized to MiECC (n = 30) and CECC (n = 30). Primary endpoint was tumor necrosis factor-α. Secondary endpoints were other biochemical markers of inflammation (IL1β, IL6 and IL8, C-reactive protein, leukocytes), and markers of inadequate tissue perfusion and tissue damage (lactate dehydrogenase, lactate and creatine kinase-MB). In addition, we registered signs of systemic inflammatory response syndrome, haemodynamic instability, atrial fibrillation, respiratory dysfunction, and infection.
    RESULTS: Patients treated with MiECC showed significantly lower levels of tumor necrosis factor-α than CECC during and early after extracorporeal circulation (median: MiECC 3.4 pg/mL; CI 2.2-4.5 vs. CECC 4.6 pg/mL; CI 3.4-5.6; p = 0.01). Lower levels of creatine kinase-MB and lactate dehydrogenase suggested less tissue damage. However, we detected no other significant differences in any other markers of inflammation, tissue damage or in any of the clinical outcomes.
    CONCLUSIONS: Lower levels of TNF-α after MiECC compared with CECC may reflect reduced inflammatory response, although other biochemical markers of inflammation were comparable. Our results suggest better end-organ protection with MiECC compared with CECC. Clinical parameters related to systemic inflammatory response were comparable in this study.
    BACKGROUND: NCT03216720.
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  • 文章类型: English Abstract
    Cardiovascular surgery risk prediction models are widely applied in medical practice. However, they have been criticized for their low methodological quality and scarce external validation. An additional limitation added in Latin America is that most of these models have been developed in the United States or Europe, which present marked geographical differences. The objective of this study is to characterize the postoperative clinical events of cardiovascular surgeries with the use of cardiopulmonary bypass pump in a local setting and to evaluate the prediction of postoperative mortality using the EuroSCORE II predictive model.
    Cross-sectional study in an urban university hospital in Buenos Aires. Patients ≥21 years of age were included, with a clinical indication for on-pump cardiovascular surgery. Patients with incomplete clinical data regarding EuroSCORE II variables or in-hospital survival, ≥95 years of age, or undergoing heart transplantation were excluded.
    195 patients were enrolled. Postoperative mortality estimated by EuroSCORE II presented a clear underestimation of risk (3.0% vs 7.7%). Discrimination (AUC = 0.82; 95% CI 0.74-0.92) and goodness of fit of the model were adequate (χ2 = 7.91; p = 0.4418). The most frequent postoperative complications were postoperative heart failure (35.9%), vasoplegic shock (13.3%), and cardiogenic shock (10.26%).
    The EuroSCORE II is an appropriate tool to discriminate between different risk categories in patients undergoing on-pump cardiovascular surgery, although it underestimates the risk.
    Los modelos de predicción de riesgo de cirugías cardiovasculares se aplican ampliamente a la práctica médica. Sin embargo, han sido criticados por su baja calidad metodológica y escasa validación externa. En América Latina se agrega la limitación de que la mayoría de estos modelos fueron desarrollados en Estados Unidos o Europa, existiendo diferencias geográficas marcadas.
    El objetivo de este estudio es caracterizar los eventos clínicos postoperatorios de cirugías cardiovasculares con uso de bomba de circulación extracorpórea en un escenario local y evaluar la predicción de mortalidad postoperatoria del modelo predictivo EuroSCORE II.
    Corte transversal en un hospital universitario urbano de Buenos Aires. Se incluyeron a pacientes ≥21 años de edad, con indicación de cirugía cardiovascular con uso de bomba. Se excluyeron a pacientes con datos clínicos incompletos respecto a las variables del EuroSCORE II o respecto a la sobrevida intrahospitalaria, con ≥95 años de edad o sometidos a trasplante cardíaco.
    Se enrolaron 195 pacientes. La mortalidad postoperatoria estimada por el EuroSCORE II presentó una clara subestimación del riesgo (3,0% vs 7,7%). La discriminación (AUC = 0,82; IC95% 0,74-0,92) y la bondad del ajuste del modelo fueron adecuadas (χ2 = 7,91; p = 0,4418). Las complicaciones postoperatorias más frecuentes fueron insuficiencia cardíaca postoperatoria (35,9%), shock vasopléjico (13,3%) y shock cardiogénico (10,26%).
    El EuroSCORE II es una herramienta apropiada para discriminar entre diferentes categorías de riesgo en pacientes sometidos a cirugías cardiovasculares con uso de bomba, si bien subestima el riesgo.
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  • 文章类型: Journal Article
    背景:该试验假设微创体外循环(MiECC)降低了需要体外循环而不停止循环的心脏手术后严重不良事件(SAE)的风险。
    方法:这是一个多中心,14个心脏手术中心的国际随机对照试验,包括年龄≥18岁和<85岁的择期或紧急单纯性冠状动脉旁路移植术(CABG)患者,孤立性主动脉瓣置换术(AVR)手术,或CABG+AVR手术。参与者被随机分配到MiECC或常规体外循环(CECC),按中心和操作分层。主要结果是手术后30天内12次SAE的复合结果,假设MiECC降低的风险。次要结果包括:其他SAE;全因死亡率;输血;重症监护和医院出院时间;健康相关生活质量。分析是在改良的意向治疗基础上进行的。
    结果:由于COVID-19大流行,试验提前终止;1071名参与者(896名孤立的CABG,97隔离AVR,69CABG+AVR),中位年龄66岁,中位EuroSCOREII1.24被随机分配(535至MiECC,536至CECC)。26名参与者在随机分组后退出,干预前22和干预后4。517例(9.7%)随机分配给MiECC组和69/522例(13.2%)随机分配给CECC组的主要结果(风险比=0.732,95%置信区间(95%CI)=0.556至0.962,p=0.025)。任何不影响主要结局的SAE的风险也同样降低(风险比=0.791,95%CI0.530至1.179,p=0.250)。
    结论:MiECC可将主要结局事件的相对风险降低约25%。其他SAE的风险也同样降低。因为试验在没有达到目标样本量的情况下提前终止,MiECC的这些潜在好处是不确定的。
    BACKGROUND: The trial hypothesized that minimally invasive extra-corporeal circulation (MiECC) reduces the risk of serious adverse events (SAEs) after cardiac surgery operations requiring extra-corporeal circulation without circulatory arrest.
    METHODS: This is a multicentre, international randomized controlled trial across fourteen cardiac surgery centres including patients aged ≥18 and <85 years undergoing elective or urgent isolated coronary artery bypass grafting (CABG), isolated aortic valve replacement (AVR) surgery, or CABG + AVR surgery. Participants were randomized to MiECC or conventional extra-corporeal circulation (CECC), stratified by centre and operation. The primary outcome was a composite of 12 post-operative SAEs up to 30 days after surgery, the risk of which MiECC was hypothesized to reduce. Secondary outcomes comprised: other SAEs; all-cause mortality; transfusion of blood products; time to discharge from intensive care and hospital; health-related quality-of-life. Analyses were performed on a modified intention-to-treat basis.
    RESULTS: The trial terminated early due to the COVID-19 pandemic; 1071 participants (896 isolated CABG, 97 isolated AVR, 69 CABG + AVR) with median age 66 years and median EuroSCORE II 1.24 were randomized (535 to MiECC, 536 to CECC). Twenty-six participants withdrew after randomization, 22 before and four after intervention. Fifty of 517 (9.7%) randomized to MiECC and 69/522 (13.2%) randomized to CECC group experienced the primary outcome (risk ratio = 0.732, 95% confidence interval (95% CI) = 0.556 to 0.962, p = 0.025). The risk of any SAE not contributing to the primary outcome was similarly reduced (risk ratio = 0.791, 95% CI 0.530 to 1.179, p = 0.250).
    CONCLUSIONS: MiECC reduces the relative risk of primary outcome events by about 25%. The risk of other SAEs was similarly reduced. Because the trial terminated early without achieving the target sample size, these potential benefits of MiECC are uncertain.
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  • 文章类型: Randomized Controlled Trial
    心脏手术(CS)与体外循环(ECC),诱导强烈的氧化应激(OS)和全身炎症反应(SIR),严重影响术后肺功能。我们的目的是测试高肠胃外(200毫克/千克/24小时)每日剂量的维生素C(VitC),在手术开始后48小时内给出,可以降低CS患者术后肺部并发症(PPCs)的发生率和严重程度。这个单一中心,prospective,随机化,单盲,介入试验包括150名患者,分为对照组A(n=75)和干预组B(n=75)。B组术中接受了四分之一(即,50mg/kg)的计划每日VitC剂量,分成三等份,用10毫升生理盐水稀释,而A组在相同的时间范围内接受了等量的生理盐水(即,麻醉诱导,主动脉交叉钳释放,和胸骨闭合)。从第一次术中给药6小时后,采用以下方案:B组:50mg/kg,30分钟静脉输注VitC在50mL生理盐水中,每6小时,在接下来的48小时内,A组:每6小时静脉输注等体积生理盐水30分钟,在接下来的48小时内,使用改良的Kroenke评分来确定PPC的发生率和严重程度。PPC的总发生率为36.7%,B组明显较低(13.3%vs.60.0%,p<0.001)。B组的PPCs严重程度评分也显着降低(1vs.3,p<0.001)。此外,B组患者肺部损伤明显较少,术后肾功能更好,ICU住院时间较短,更少的ICU再入院,医院死亡率较低。没有记录到VitC相关的不良反应。在CS开始后48小时内给予高的肠胃外每日VitC剂量对于降低PPC的发生率和严重程度是安全有效的。需要多中心RCT来确认这些结果。
    Cardiac surgery (CS) with extracorporeal circulation (ECC), induces intense oxidative stress (OS) and systemic inflammatory response (SIR), which may seriously affect postoperative lung function. We aimed to test if high parenteral (200 mg/kg/24 h) daily doses of Vitamin C (VitC), given within 48 h after the beginning of the operation, may reduce the incidence and severity of postoperative pulmonary complications (PPCs) in CS patients. This single-center, prospective, randomized, single-blinded, interventional trial included 150 patients, assigned to control Group A (n = 75) and interventional Group B (n = 75). Group B intraoperatively received one-fourth (i.e., 50 mg/kg) of the planned daily Vit C dose, divided into three equal parts and diluted in 10 mL of normal saline, while Group A received an equal volume of normal saline at the same time frames (i.e., the induction of anesthesia, aortic cross-clamp release, and sternal closure). After 6 h from the first intraoperative dose, the following regimen was applied: Group B: 50 mg/kg, 30 min i.v. infusion of VitC in 50 mL of normal saline, every 6 h, for the next 48 h, and Group A: 30 min i.v. infusion of an equal volume of normal saline every 6 h, for the next 48 h. Modified Kroenke\'s score was used to determine the incidence and severity of PPCs. The overall incidence of PPCs was 36.7% and was significantly lower in Group B (13.3% vs. 60.0%, p < 0.001). The PPCs severity score was also significantly lower in Group B (1 vs. 3, p < 0.001). In addition, patients from Group B had significantly less damaged lungs, better postoperative renal function, shorter ICU stays, fewer ICU re-admissions, and lower hospital mortality. No VitC-related adverse effects were recorded. High parenteral daily VitC doses given within 48 h after the beginning of CS are safe and effective in reducing the incidence and severity of PPCs. A multicenter RCT is needed to confirm these results.
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  • 文章类型: Observational Study
    背景:事件的时间顺序的影响,包括心脏骤停(CA),初次心肺复苏术(CPR),自主循环恢复(ROSC),和体外心肺复苏(ECPR)的实施,院外心脏骤停(OHCA)和院内心脏骤停(IHCA)患者的临床结局,仍然不清楚。这项研究的目的是调查从崩溃到开始CPR的时间间隔的预后影响(无流量时间,NFT)和从CPR开始到实施ECPR的时间间隔(低流量时间,LFT)关于体外膜氧合(ECMO)下患者的预后。
    方法:这种单中心,在哈马德总医院(HGH)对48例接受ECMO的OHCA或IHCA患者进行了回顾性观察研究,卡塔尔三级政府医院,2016年2月至2020年3月。我们调查了NFT和LFT等预后因素对心脏骤停后各种临床结局的影响。包括24小时存活,28天存活,CPR持续时间,ECMO逗留时间(LOS),ICULOS,医院LOS,残疾(使用改良的Rankin量表评估,mRS),和神经状态(根据大脑性能类别评估,CPC)在CA后28天。
    结果:调整后的logistic回归分析结果显示,NFT时间较长与临床结局不良相关。这些结果包括CPR持续时间延长(OR:1.779,95CI:1.218-2.605,P=0.034)和ECMO在24h(OR:0.561,95CI:0.183-0.903,P=0.009)和28天(OR:0.498,95CI:0.106-0.802,P=0.011)的生存率降低。此外,研究发现,LFT越长,CPR时间越长的概率越高(OR:1.818,95CI:1.332~3.312,P=0.006).然而,心脏骤停28天后,NFT或LFT与残疾改善或神经系统有利生存率之间无统计学意义的联系.
    结论:根据我们的发现,在评估接受ECMO治疗的OHCA或IHCA患者的临床结局方面,NFT比LFT更有效.这种对他们独特预测能力的理解使医疗专业人员能够更准确地识别高风险患者,并相应地定制他们的干预措施。
    BACKGROUND: The impact of the chronological sequence of events, including cardiac arrest (CA), initial cardiopulmonary resuscitation (CPR), return of spontaneous circulation (ROSC), and extracorporeal cardiopulmonary resuscitation (ECPR) implementation, on clinical outcomes in patients with both out-of-hospital cardiac arrest (OHCA) and in-hospital cardiac arrest (IHCA), is still not clear. The aim of this study was to investigate the prognostic effects of the time interval from collapse to start of CPR (no-flow time, NFT) and the time interval from start of CPR to implementation of ECPR (low-flow time, LFT) on patient outcomes under Extracorporeal Membrane Oxygenation (ECMO).
    METHODS: This single-center, retrospective observational study was conducted on 48 patients with OHCA or IHCA who underwent ECMO at Hamad General Hospital (HGH), the tertiary governmental hospital of Qatar, between February 2016 and March 2020. We investigated the impact of prognostic factors such as NFT and LFT on various clinical outcomes following cardiac arrest, including 24-hour survival, 28-day survival, CPR duration, ECMO length of stay (LOS), ICU LOS, hospital LOS, disability (assessed using the modified Rankin Scale, mRS), and neurological status (evaluated based on the Cerebral Performance Category, CPC) at 28 days after the CA.
    RESULTS: The results of the adjusted logistic regression analysis showed that a longer NFT was associated with unfavorable clinical outcomes. These outcomes included longer CPR duration (OR: 1.779, 95%CI: 1.218-2.605, P = 0.034) and decreased survival rates for ECMO at 24 h (OR: 0.561, 95%CI: 0.183-0.903, P = 0.009) and 28 days (OR: 0.498, 95%CI: 0.106-0.802, P = 0.011). Additionally, a longer LFT was found to be associated only with a higher probability of prolonged CPR (OR: 1.818, 95%CI: 1.332-3.312, P = 0.006). However, there was no statistically significant connection between either the NFT or the LFT and the improvement of disability or neurologically favorable survival after 28 days of cardiac arrest.
    CONCLUSIONS: Based on our findings, it has been determined that the NFT is a more effective predictor than the LFT in assessing clinical outcomes for patients with OHCA or IHCA who underwent ECMO. This understanding of their distinct predictive abilities enables medical professionals to identify high-risk patients more accurately and customize their interventions accordingly.
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  • 文章类型: Journal Article
    UNASSIGNED: To investigate the correlation between the amount of sufentanil used during anesthesia and intraoperative hemodynamic fluctuation and postoperative recovery in patients undergoing cardiopulmonary bypass (CPB).
    UNASSIGNED: A retrospective analysis was performed on 454 patients undergoing elective heart surgery under CPB. Patients were divided into two groups according to the amount of sufentanil used during anesthesia: Group L (induced sufentanil 0.4-0.6 ug /kg, maintained sufentanil 0.01-0.02 ug/kg/min, n = 223) and Group H (induced sufentanil 4-6 ug/kg, maintained sufentanil 0.02-0.03 ug/kg/min, n = 231). Propensity score matching (PSM) was used at a 1:1 nearest-neighbor ratio to compare the two groups. Intraoperative use of vasoactive drugs, spontaneous heart rebound, secondary endotracheal intubation, postoperative mechanical ventilation time, the length of stay (LOS) in ICU, postoperative LOS in hospital, postoperative in-hospital mortality were analyzed.
    UNASSIGNED: After matching, a total of 144 patients were included (72 patients in Group L, and 72 patients in Group H). Multivariate logistic regression analysis showed that the dosage of sufentanil during anesthesia was significantly correlated with the utilization rate of intraoperative vasoactive drugs (P < 0.001) and the success rate of spontaneous heart rebound (p = 0.001). The utilization rate of vasoactive drugs decreased significantly in Group H (OR, 0.062; 95% CI, 0.019-0.200) compared to that of Group L. The success rate of spontaneous heart rebound (OR, 0.187; 95% CI, 0.071-0.491) was higher in Group H. There were no differences on postoperative recovery outcomes between the two groups.
    UNASSIGNED: On the basis of our data, the use of high-dose sufentanil is beneficial to keep the cardiovascular response of patients in a stable state, but there is no significant effect on the quality of early postoperative recovery.
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  • 文章类型: Journal Article
    暂无摘要。
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  • 文章类型: Journal Article
    背景:血栓栓塞性卒中仍然是迄今为止机械循环辅助装置支持的患者中最常见的严重不良事件。研究了使用多普勒超声检测体外回路中循环血栓的可行性。
    方法:设置无涂层体外循环管和滚柱泵的模拟体外循环回路。多普勒气泡计数器用于监测平均超声反向散射信号(MUBS)。该研究包括两组实验。在方案1中,回路依次灌注了人体血液成分,并测量MUBS。在方案2中,回路用肝素化的新鲜猪血灌注,并测量MUBS。新鲜血液凝块(直径<1,000微米,1,000-5,000微米,>5,000微米)注射到回路中,然后施用鱼精蛋白。
    结果:在方案1(n=3)中,人血小板产生1.5至3.5伏/秒的基线MUBS。添加堆积的人红细胞将基线反向散射增加到17至21伏/秒。添加新鲜冷冻血浆不改变基线反向散射。在场景2(n=5)中,血液灌注回路产生稳定的基线MUBS。凝块的注入导致基线MUBS的突然和瞬时增加(范围:3-30伏/秒)。鱼精蛋白给药导致MUBS的持续增加,随后发生回路血栓形成。
    结论:多普勒超声可用于体外回路中循环固体微栓子的实时检测。该技术可用于设计安全系统,以降低与机械循环支持治疗相关的血栓栓塞性中风的风险。
    BACKGROUND: Thromboembolic stroke continues to be by far the most common severe adverse event in patients supported with mechanical circulatory assist devices. Feasibility of using Doppler ultrasound to detect circulating thrombi in an extracorporeal circuit was investigated.
    METHODS: A mock extracorporeal circulatory loop of uncoated cardiopulmonary bypass tubing and a roller pump was setup. A Doppler bubble counter was used to monitor the mean ultrasound backscatter signal (MUBS). The study involved two sets of experiments. In Scenario 1, the circuit was sequentially primed with human blood components, and the MUBS was measured. In Scenario 2, the circuit was primed with heparinized fresh porcine blood, and the MUBS was measured. Fresh blood clots (diameter <1,000 microns, 1,000-5,000 microns, >5,000 microns) were injected into the circuit followed by protamine administration.
    RESULTS: In Scenario 1 (n = 3), human platelets produced a baseline MUBS of 1.5 to 3.5 volts/s. Addition of packed human red blood cells increased the baseline backscatter to 17 to 21 volts/s. Addition of fresh frozen plasma did not change the baseline backscatter. In Scenario 2 (n = 5), the blood-primed circuit produced a steady baseline MUBS. Injection of the clots resulted in abrupt and transient increase (range: 3-30 volts/s) of the baseline MUBS. Protamine administration resulted in a sustained increase of MUBS followed by circuit thrombosis.
    CONCLUSIONS: Doppler ultrasound may be used for real-time detection of circulating solid microemboli in the extracorporeal circuit. This technology could potentially be used to design safety systems that can reduce the risk of thromboembolic stroke associated with mechanical circulatory support therapy.
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  • 文章类型: Randomized Controlled Trial
    原理:目前尚不清楚体外CO2清除(ECCO2R)是否可以减少成人COPD恶化的插管率或有创机械通气(IMV)的总时间。目的:确定ECCO2R是否会增加非侵入性通气(NIV)失败或无法摆脱IMV的COPD患者在随机分组(VFD-5)后的前5天内的无呼吸机天数。方法:随机,临床试验在41家美国机构(2018-2022年)进行(NCT03255057).受试者随机接受静脉静脉ECCO2R标准护理(NIV层:n=26;IMV层:n=32)或仅接受标准护理(NIV层:n=22;IMV层:n=33)。测量和主要结果:由于招募缓慢,该试验提前停止,并招募了113名计划样本量为180的受试者。由地层控制的组之间的VFD-5中位数没有显着差异(p=0.36)。在NIV地层中,两组患者的VFD-5中位数为5.00天(中位数移位(95CI)=0.0(0.0~0.0)).在IMV地层中,标准治疗组和ECCO2R组的VFD-5中位数分别为0.25和2.00天,分别(中位数偏移(95CI):0.00(0.00-1.25))。在NIV地层中,ECCO2R组的全因住院死亡率明显更高(22%vs0%,p=0.02),IMV地层无差异(17%与15%,p=0.73)。结论:在COPD加重的受试者中,与标准护理相比,使用ECCO2R并未改善第5天的无呼吸机天数。临床试验注册可在www.clinicaltrials.gov,ID:NCT03255057。
    Rationale: It is unclear whether extracorporeal CO2 removal (ECCO2R) can reduce the rate of intubation or the total time on invasive mechanical ventilation (IMV) in adults experiencing an exacerbation of chronic obstructive pulmonary disease (COPD). Objectives: To determine whether ECCO2R increases the number of ventilator-free days within the first 5 days postrandomization (VFD-5) in exacerbation of COPD in patients who are either failing noninvasive ventilation (NIV) or who are failing to wean from IMV. Methods: This randomized clinical trial was conducted in 41 U.S. institutions (2018-2022) (ClinicalTrials.gov ID: NCT03255057). Subjects were randomized to receive either standard care with venovenous ECCO2R (NIV stratum: n = 26; IMV stratum: n = 32) or standard care alone (NIV stratum: n = 22; IMV stratum: n = 33). Measurements and Main Results: The trial was stopped early because of slow enrollment and enrolled 113 subjects of the planned sample size of 180. There was no significant difference in the median VFD-5 between the arms controlled by strata (P = 0.36). In the NIV stratum, the median VFD-5 for both arms was 5 days (median shift = 0.0; 95% confidence interval [CI]: 0.0-0.0). In the IMV stratum, the median VFD-5 in the standard care and ECCO2R arms were 0.25 and 2 days, respectively; median shift = 0.00 (95% confidence interval: 0.00-1.25). In the NIV stratum, all-cause in-hospital mortality was significantly higher in the ECCO2R arm (22% vs. 0%, P = 0.02) with no difference in the IMV stratum (17% vs. 15%, P = 0.73). Conclusions: In subjects with exacerbation of COPD, the use of ECCO2R compared with standard care did not improve VFD-5. Clinical trial registered with www.clinicaltrials.gov (NCT03255057).
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