The characteristics of the continuously-recorded mechanical power and its associated clinical outcomes in medical patients with respiratory failure (CORE POWER) study: The protocol of prospective observation study.

Akarawut Kasemchaiyanun, Detajin Junhasavasdikul, P. Theerawit
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Abstract

Background: The amount of energy delivered from the ventilator applied to the lungs within a given timeframe, is defined as mechanical power (MP). Recently, low MP is one of the new concepts in lung-protective ventilation strategies that may associate with survival benefit. However, measuring MP requires additional calculations not being carried-out in usual clinical care and the reports about MP were mostly a cross-sectional data. The real-time changes or dynamic data of MP was scarcely reported. Our objective is to investgate the association between the dynamic changes of MP and clinical outcomes in critically ill patients. Methods: This will be a prospective, observational study performed in a single center. Adult patients admitted to medical intermediate and intensive care units who requiring invasive mechanical ventilation will be consecutively enrolled. The patients’ ventilators will be connected to the specific investigator’s computer system for continuously real-time data recording for at least 24 hours. The primary outcome is in-hospital mortality. Hypothesis: We hypothesize that excessive mechanical power during mechanical ventilation contributes to ventilator-induced lung injury, thus real-time continuously mechanical power monitoring may reduce adverse events associated with mechanical ventilation. Ethic: The study protocol has been approved by the Institution Review Board of Ramathibodi Hospital, Mahidol University, Thailand (No. MURA2021/680). Trial registration: TCTR20220202010
内科呼吸衰竭患者连续记录机械功率特征及其相关临床结局(CORE power)研究:前瞻性观察研究方案
背景:在给定的时间范围内,从呼吸机输送到肺部的能量被定义为机械功率(MP)。最近,低MP是肺保护性通气策略的新概念之一,可能与生存益处有关。然而,测量MP需要额外的计算,而不是在通常的临床护理中进行,并且关于MP的报告大多是横截面数据。MP的实时变化或动态数据鲜有报道。我们的目的是研究危重患者MP动态变化与临床结果之间的关系。方法:这将是一项在单中心进行的前瞻性观察性研究。需要有创机械通气的医疗中级和重症监护病房的成年患者将连续入组。患者的呼吸机将连接到特定研究者的计算机系统,进行至少24小时的连续实时数据记录。主要结局是住院死亡率。假设:我们假设机械通气过程中过大的机械功率会导致呼吸机引起的肺损伤,因此实时连续的机械功率监测可能会减少机械通气相关的不良事件。伦理:该研究方案已获得泰国玛希隆大学Ramathibodi医院机构审查委员会(No. 6)的批准。MURA2021/680)。试验注册号:TCTR20220202010
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