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临床试验/NCT03820440
NCT03820440Unknown不适用

End-expiratory Occlusion Test and Lung Recruitment Maneuver to Assess Fluid responsiVeness In Surgical Patients: an Open-label, Randomized Clinical Trial

Humanitas Clinical and Research Center2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年5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
2
主要终点
AUC difference

研究概览

简要总结

The functional hemodynamic test (FHT) called passive leg raising (PLR) has been successfully used for assessing the fluid responsiveness in ICU patients since 2009 and its reliability has been confirmed by three large meta-analyses. However, the PLR is not usually practicable in the OR.

A lot of different FHTs have been proposed, as alternative to the PLR, in ICU and, more recently, OR. These tests could be basically subdivided in two groups. A subgroup of FHTs is based on sudden and brief variations of the mechanical ventilation to induce a change in right ventricle preload and/or after load and, as consequence, of left ventricle SV. A second subgroup aims at testing the increase in SV after the rapid administration of a small aliquot of the predefined FC.

Among the first group, the end-expiratory occlusion test (EEOT) and the lung recruitment maneuver (LRM) have been previously successfully tested in surgical patients. The EEOT consists of the interruption of the mechanical ventilation for 30 seconds, whereas the LRM consists in the increase in the peak inspiratory pressure up to 30 cmH20 for 30 seconds and in the assessment of the changes in the SV after the maneuvers. These tests are safe and can be easily applicable during the surgery to predict fluid responsiveness and optimize the fluid therapy.

The primary aim of the present study is to compare the reliability of EEOT and LRM in predicting fluid responsiveness in patients undergoing general surgery.

详细描述

Targeted fluid therapy has received increasing attention in the management of patients showing acute circulatory failure in both intensive care unit (ICU) and operating room (OR), aiming at preventing both inadequate tissue blood flow and fluid overload [1]. In fact, unnecessary fluid administration can increase morbidity and mortality and length of hospital stay of critically ill and surgical patients [2-10].

Since the only physiological reason to give a fluid challenge (FC) is to increase the stroke volume (SV) [11-13] and this effect is obtained only in about 50% of ICU and OR patients [14, 15], a vast literature investigated the possibility of predict this effect before FC administration, but the issue remains extremely challenging [1, 13, 16-18]. Bedside clinical signs and pressure and static volumetric static variables, do not predict fluid responsiveness [17]. Moreover, several physiological factors affect the reliability of the ventilator-induced dynamic changes in pulse pressure and stroke volume [pulse pressure variation (PPV) and stroke volume variation (SVV), respectively], and their echographic surrogates, in a significant number of ICU and OR patients [19-22].

To overcome these limitations, the functional hemodynamic assessment (i.e. the assessment of the dynamic interactions of hemodynamic variables in response to a defined perturbation), of fluid responsiveness has gained in popularity [17, 18, 23]. A functional hemodynamic test (FHT) consist in a manoeuvre determining a sudden change in cardiac function and/or heart lung interaction, affecting the hemodynamics of fluid responders and non-responders to a different extent [17, 18, 23].

The FHT called passive leg raising (PLR) has been successfully used for assessing the fluid responsiveness in ICU patients since 2009 [24] and its reliability has been confirmed by three large meta-analyses [25-27]. However, the PLR is not usually practicable in the OR.

A lot of different FHTs have been proposed, as alternative to the PLR, in ICU and, more recently, OR. These tests could be basically subdivided in two groups. A subgroup of FHTs is based on sudden and brief variations of the mechanical ventilation to induce a change in right ventricle preload and/or after load and, as consequence, of left ventricle SV [24, 28]. A second subgroup aims at testing the increase in SV after the rapid administration of a small aliquot of the predefined FC [29, 30].

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • Adult patients aged ≥ 18 years;
  • Scheduled for elective supine abdominal surgery and requiring invasive arterial monitoring;
  • Glasgow coma scale 15 at recruitment. All the patients must be able to sign an informed consent at the admission.

排除标准

  • Any recurrent cardiac arrhythmias;
  • Reduced left (ejection fraction <30%) or right (systolic peak velocity of tricuspid annular motion <0.17 m/s) ventricular systolic function;
  • Chronic use beta-blocking agents.
  • History of pneumothorax.

结局指标

主要结局

AUC difference

时间窗: 10 minutes after fluid challenge administration

To assess the difference in the area under (AUC) the receiving operator characteristic curve (ROC)

次要结局

  • Sensitivity and Specificity(10 minutes after fluid challenge administration)

研究者

发起方
Humanitas Clinical and Research Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Antonio Messina

ICU senior consultant

Humanitas Clinical and Research Center

研究点 (2)

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