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临床试验/NCT05180409
NCT05180409Unknown不适用

The Prognostic Value of Simultaneous Assessment of Microcirculation Alteration With Sublingual Microcirculation and Near-infrared Spectroscopy on the Acute Respiratory Distress Syndrome of Various Phenotypes

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
1
主要终点
Predictive power of the near-infrared spectroscopy and sublingual microcirculation for the prognosis of ARDS

研究概览

简要总结

Microcirculatory alterations are frequently observed in critically ill and severe sepsis patients characterized by a decrease in capillary density and an increase in heterogeneity of perfusion. This derangements result in microcirculatory shunting and oxygen extraction deficit, and plays a major role in the pathophysiology of sepsis and multi-organ failure. Loss of hemodynamic coherence between the macro- and microcirculation results in persistent and incomplete reversal of microcirculatory and regional hypoxia that is the major factor contributing to the development of organ failure.

Current techniques permitting monitoring the microcirculation can be classified in two main groups: (1) Methods for evaluation of local tissue oxygenation as a surrogate of microcirculatory blood flow. (2)Methods allowing direct visualization of the microvascular network and microcirculatory blood flow.

Near-infrared spectroscopy (NIRS) is a non-invasive technique for evaluating tissue oxygenation in vessels with a diameter < 1 mm (arterioles, capillaries, and venules). Recent systemic review studies have showed that patients with severe sepsis or septic shock have lower levels of StO2, moreover, survivors present higher levels of StO2 compared with non-survivors. Reactive hyperemia during vascular occlusion test (VOT) can be considered an integral test of microcirculatory reactivity, evaluating the tissue's ability to adjust oxygen extraction capabilities to oxygen delivery after a hypoxic stimulus induced by a transient interruption in blood flow. Continuous StO2 measurement and VOT derived StO2 deoxygenation slope and StO2 recovery slope have been found to be predictors of mortality and organ dysfunction.

Sublingual microcirculation allows direct visualization of the sublingual microcirculation and for quantitative determination of variables of flow, capillary density, and flow distribution. Microvascular alterations including decreased functional capillary density, increased perfusion heterogeneity, and increased proportion of stopped and intermittently perfused capillaries, are more severe in non-survivors than in survivors. In addition, persistence of these alterations was strongly and independently correlated with multi-organ failure and mortality.

ARDS is the most severe form of acute lung injury in ICU with mortality about 45% without achievement in ten years. However, only few studies were focused on the microcirculatory alterations in ARDS patients.

详细描述

Microcirculation consists of a branching network of small blood vessels (<100 μm diameter) that includes the arterioles, capillaries, and venules, and plays a pivotal role in the delivery of oxygen to tissue cells. Microcirculatory alterations are frequently observed in critically ill patients, and especially in patients with severe sepsis. These alterations are characterized by a decrease in capillary density that determines an increase in the diffusion distance of oxygen to tissues and an increase in heterogeneity of perfusion. This microcirculatory derangements involve the consequent presence of under or not perfused capillaries in close proximity to well perfused capillaries. Therefore, these functionally vulnerable microcirculatory areas may become hypoxic, resulting in an oxygen extraction deficit. This phenomenon has been termed "microcirculatory shunting" and plays a major role in the pathophysiology of sepsis and multi-organ failure.

Persistent and incomplete reversal of microcirculatory and regional hypoxia is considered to be a major factor contributing to the development and maintenance of multiple organ failure. Unfortunately, alterations in microvascular perfusion often persist after the correction of systemic hemodynamic abnormalities, and their severity is associated with a poor outcome. Such a loss of hemodynamic coherence between the macro- and microcirculation has been described in several clinical and experimental studies and has been found to be an independent predictor of adverse outcome and organ dysfunction. The microcirculation has been suggested to be the motor of sepsis.

Conceptually, current techniques that permit monitoring the microcirculation can be classified in two main groups: (1) Methods that allow evaluation of local tissue oxygenation as a surrogate of microcirculatory blood flow. (2) Methods that allow direct visualization of the microvascular network and microcirculatory blood flow.

Near-infrared spectroscopy (NIRS) has been used as a tool to monitor tissue oxygen saturation (StO2) in acutely ill patients and has been proposed as a tool to quantify microvascular dysfunction in patients with sepsis. According to Beer's law, the NIRS signal is limited to vessels that have a diameter less than 1 mm (arterioles, capillaries, and venules), but, as 75% of the blood in a skeletal muscle is venous, NIRS StO2 measurements mostly represent local venous hemoglobin O2 saturation. NIRS has been used in different clinical conditions such as severe trauma, hemorrhagic shock, septic shock, and cardiogenic shock or severe cardiac failure. The utility of and application of NIRS in intensive care mainly involved three main NIRS measurements: (1) continuous tissue oxygen saturation (StO2) measurement; 2) StO2 deoxygenation slope (DecStO2 slope) in response to vascular occlusion test (VOT test); and 3) StO2 recovery slope (RincStO2 slope) in response to VOT.

Tissue oxygen saturation (StO2) has been proposed as a marker of tissue perfusion depending on the device used and the location of the measurement. A systemic review and mea-analysis had showed that patients with severe sepsis or septic shock have lower levels of StO2, and RincStO2 slope. Moreover, survivors from severe sepsis or septic shock present higher levels of StO2 and RincStO2 compared with non-survivors. The VOT is a provocative test in which StO2 is measured on a distal site (such as the thenar eminence or forearm) whilst a transient rapid vascular occlusion is performed, using a sphygmomanometer, for either a defined time interval (for example, 3 minutes) or until the StO2 decreases to a defined minimal threshold. The ischemic tissue then induces vasodilation of surrounding arterioles, metarterioles and pre-capillary sphincters to decrease local vascular resistance and regain blood flow. Once this threshold is reached, the tourniquet is released and blood flow is restored. There is a reactive hyperemic response which represents the tissue's ability to auto-regulate blood flow and oxygenation. Several parameters arise from this technique, including: 1. the rate of deoxygenation (RdecStO2), thought to reflect the local metabolic rate, 2. the rate of reoxygenation (RincStO2), thought to reflects the time required to wash out stagnant blood and is thought to be determined by local cardiovascular reserve and microcirculatory flow, and the post-obstructive hyperemic response.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ARDS patients conforming to the Berlin Definition of Acute Respiratory Distress Syndrome
  • ventilatory support with mechanical ventilation

排除标准

  • age < 18 years
  • pregnancy
  • established "Do Not Resuscitate" orders prior to enrollment
  • acute cerebrovascular event (primary diagnosis)
  • combined with acute coronary syndrome with myocardial infarction (primary diagnosis)
  • acute and active gastrointestinal bleeding (primary diagnosis)
  • requirement for immediate surgery
  • inability to obtain written informed consent

结局指标

主要结局

Predictive power of the near-infrared spectroscopy and sublingual microcirculation for the prognosis of ARDS

时间窗: 28 days mortality after admission into ICU

The outcomes variables planned to be recorded are area under the receiver operating characteristic (ROC) curve for the sublingual microcirculation and near-infrared spectroscopy to predict mortality of ARDS

次要结局

未报告次要终点

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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