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临床试验/NCT05410262
NCT05410262已完成不适用

Specific Mechanical Power Assessment in Patients With Acute Respiratory Distress Syndrome

Hospital El Cruce1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2022年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
18
试验地点
1
主要终点
specific mechanical power

研究概览

简要总结

In ARDS patients, mechanical ventilation should minimize ventilator-induced lung injury. The mechanical power which is the energy per unit time released to the respiratory system according to the applied tidal volume, PEEP, respiratory rate, and flow should reflect the ventilator-induced lung injury

详细描述

Mechanical ventilation is an essential tool for the treatment of patients with acute respiratory distress syndrome (ARDS); however, as other strategies, it is not free of complications. Inadequate ventilation may have a negative impact on the lung that may eventually cause the development of multiple organ failure and death. This process is known as ventilator-induced lung injury (VILI). From a clinical perspective, one of the most important objectives of ARDS treatment is to avoid or mitigate the development of VILI, not only to preserve pulmonary integrity, but also to reduce mortality.

Ventilator-induced lung injury results from the interaction between the mechanical load applied to the lung and its capacity to tolerate it. Factors such as tidal volume (Vt), plateau pressure (PPlat), lung strain or insufflation pressure (ΔP), inspiratory flow rate (VI), respiratory rate (RR), excessive inspiratory effort, high levels of FiO2 and high levels of positive end-expiratory pressure (PEEP), have been directly involved in damage mechanism. With an integrating and rheological idea, the concept of mechanical power tries to encompass the majority of these factors within a measurable unit in joules per minute, as the expression of power applied on a repetitive basis on the respiratory system in ARDS. Although the concept of MP holds promise for preventing the risk of VILI, its utility has not been proven in clinical practice until now. The main value of MP over the rest of commonly used variables for the monitoring of patients with ARDS is that it includes flow on injury mechanism (kinetic energy), accepting that an inverse relationship exists between this mechanism and the capacity of alveoli to adapt to change during the ventilation cycle (strain rate), as well as it embodies the concept of process repeatability (respiratory rate), though not of its duration. This begs the question whether we should consider its value at the moment of defining a mechanical ventilation strategy. The main disadvantage of its application is that MP conceives the respiratory system in an integrated manner and not related to or standardized with the ventilable lung portion, that is ultimately the one who has to withstand the ventilatory load; in other words, the same MP may have different consequences depending on the baby lung size or its equivalent, the severity of ARDS.

The objective of this study is to evaluate the influence of the ventilable lung size on VILI mechanisms in patients suffering from ARDS treated with protective ventilation with similar MP.

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
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients consecutively admitted with ARDS -

排除标准

  • Patients who meet any of the following criteria: history of emphysema, asthma, pneumothorax or bronchopleural fistula. Severe instability condition at the time of the study: SaO2 ≤90%, shock requiring noradrenaline ≥0,5 γ/kg/min, ventricular arrhythmia, myocardial ischemia and endocranial hypertension. Esophageal pathology that contraindicates esophageal balloon placement. Severe coagulopathy (platelet count <20000/mm3 or INR >4). Inability to undergo CT imaging: morbid obesity (≥170 kg) or abdominal girth >200 cm. Patients with do-not-resuscitate (DNR) orders, pregnant women and those who participated in other research studies within the last 30 days.

结局指标

主要结局

specific mechanical power

时间窗: "immediately after the intervention/procedure/surgery"

Specific mechanical power was calculated as the ratio of mechanical power to ventilable lung volume.

relationship between lung load and strain

时间窗: "immediately after the intervention/procedure/surgery"

relationship between specific mechanical power and strain

relationship between lung load and atelectrauma

时间窗: "immediately after the intervention/procedure/surgery"

relationship between specific mechanical power and atelectrauma

relationship between lung load and elastance of ARDS

时间窗: "immediately after the intervention/procedure/surgery"

relationship between specific mechanical power and elastance of ARDS

relationship between lung load and severity of ARDS

时间窗: "immediately after the intervention/procedure/surgery"

relationship between specific mechanical power and severity of ARDS

次要结局

未报告次要终点

研究者

发起方
Hospital El Cruce
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nestor Pistillo

Head of Intensive Care Unit al Hospital El Cruce

Hospital El Cruce

研究点 (1)

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