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临床试验/NCT04369027
NCT04369027Unknown不适用

Can Dynamic Changes of Pulse Pressure Variation During Passive Leg Raising or a Tidal Volume Challenge Help Predicting Preload Responsiveness in Mechanically Ventilated Patients With Spontaneous Breathing Activity

Hopital Antoine Beclere1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2019年1月6日最近更新:
适应症

试验速览

阶段
不适用
入组人数
55
试验地点
1
主要终点
predictive capacity of the changes of PPV during tidal volume challenge

研究概览

简要总结

Background: Predicting preload responsiveness by using dynamic indicators before administering fluids to critically ill patients is nowadays routinely performed at the bedside. Unlike other dynamic indicators of preload responsiveness that require cardiac output monitoring, pulse pressure variation (PPV) can be simply obtained via an arterial catheter . However, PPV is not reliable in mechanically ventilated patients with spontaneous breathing activity. We hypothesized that an increase in PPV after a tidal volume (TV) challenge (TVC) or a decrease in PPV during passive leg raising (PLR) will predict preload responsiveness in such cases.

Objective: to examine if the change in PPV during PLR and after a TVC can predict preload responsiveness in patients with mechanical ventilation and persistent spontaneous breathing

详细描述

Prospective non interventional study conducted in two intensive care units. Patients under mechanical ventilation with spontaneous cycles, for whom the physician in charge decided to test preload responsiveness were included. We collected demographic and clinical information, the use of mechanical ventilation and its parameters, the use of vasopressors and their dosage and blood lactate.

Firstly, transthoracic echocardiography (TTE) was performed to measure the velocity time integral (VTI) of the left ventricular outflow tract .

A PLR maneuvre is performed with TTE probe in place and a new assessement of VTI is measured, in addition to the PPV and other hemodynamic parmeters (Diastolic, mean and systolic arterial pressure, heart rate, CVP). Delta VTI is the difference between VTI during PLR and VTI at baseline divided by VTI at baseline.

Patients were considered as preload responsive when delta VTI was ≥10%. Secondly, a TVC was performed by increasing the TV by 2mL/kg predicted body weight from its baseline value . PPV was recorded before and after the TVC in addition to the other hemodynamic parmeters listed above. Further more, respiratory parameters are collected: ventilator setting, plateau pressure, upper airway pressure, before and during the TVC.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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 critically ill patients if the clinicians in charge decided to test preload responsiveness because of mean arterial pressure (MAP) < 65 mmHg (measured by an arterial catheter) or other symptoms of acute circulatory failure (e.g. oliguria, skin mottling, tachycardia, hyperlactatemia)

排除标准

  • Arrythmia
  • no spontaneous breathing
  • difficult condition for tansthoracic echocardiography

结局指标

主要结局

predictive capacity of the changes of PPV during tidal volume challenge

时间窗: duration of the tests: 15 minutes

A roc curve analysis will be performed in order to determine the specificity and the sensitivity of this test to predict preload responsiveness

次要结局

  • predictive capacity of changes of PPV during ppassive leg raising test(duration of the tests: 15 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hamzaoui Olfa

PRINCIPAL INVESTIGATOR

Hopital Antoine Beclere

研究点 (1)

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