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临床试验/NCT06480942
NCT06480942已完成不适用

The Performance of Changes of Pulse Pressure and of Pulse Pressure Variation to Detect Preload Responsiveness in Spontaneously Breathing Patients

CHU de Reims1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2023年10月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
CHU de Reims
入组人数
39
试验地点
1
主要终点
Diagnostic performance of the decrease in Pulse Pressure Variation (PPV) during a Passive Leg Raising test (PLR) to predict preload responsiveness

研究概览

简要总结

The management of septic shock patients includes the infusion of fluids, however fluids may be deleterious if the patient does not respond by increasing cardiac output. By consequence, it is now recommended to predict the fluid response (fluid or preload responsiveness) before infusing them. In this protocol, the investigators will include critically ill patients spontaneously breathing, for whom the physician in charge has decided to test preload responsiveness. The investigators will collect from the continuous monitoring of arterial pressure of the patient the pulse pressure(PP) which is the difference between systolic arterial pressure and diastolic arterial pressure and the pulse pressure variation (PPV) automatically displayed by the monitor in addition to other clinical (hemodynamic, respiratory) parameters. After one minute of passive leg raising manoeuvre (PLR) the investigators collect the same parameters and the investigators will compare the changes of these parameters in patients who are preload responsive to patients who are not. Preload responsiveness will de defined by echocardiographic parameters before and during PLR. More exactly, a surrogate of cardiac output measured by echocardiography wich is VTI of the sub-aorti flow; an increase of more than 12% defines apreload responsive patient.

详细描述

*Objectives:

Primary : to assess the diagnostic performance of the decrease in pulse pressure variation (PPV) during a passive leg raising test (PLR) to predict preload responsiveness in spontaneously breathing patients hospitalized in intensive care.

Secondary:

  • Evaluate the diagnostic performance of the increase in pulse pressure (PP) during a PLR test to predict preload responsiveness in this same population.

  • Compare before/after PLR measurements other hemodynamic data (blood pressure, cardiac output, heart rate).

  • Experimental scheme: it is a diagnostic and monocentric study.

  • Population / patients:

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient over 18 years old.
  • Hospitalized in intensive care.
  • For which the clinician in charge of the patient will need to predict the response to fluids and decide on a possible infusion of fluids, because of:
  • Acute circulatory failure with mean arterial pressure < 65mmHg or < 30mmHg of its baseline value for hypertensive patients.
  • And/or other signs of hemodynamic instability (tachycardia, mottling, oliguria, hyperlactatemia) :
  • In spontaneous ventilation and without ventilatory assistance.
  • Previously equipped with an arterial catheter.
  • Affiliated to a social security scheme.

排除标准

  • Patient with arrythmia (PPV is not applicable).
  • Patient with intra-abdominal hypertension (PLR test is not valid).
  • Patient with a contraindication/impossibility to the PLR maneuver (lower limb amputation, respiratory intolerance).
  • Patient with poor echogenicity noted previously.
  • Patient protected by law.

研究组 & 干预措施

Positive PLR test (PLR +)

  • Patient over 18 years old.

  • Hospitalized in intensive care.

  • For which the clinician in charge of the patient will need to predict the response to fluids and decide on a possible infusion of fluids, because of:

  • Acute circulatory failure with mean arterial pressure < 65mmHg or < 30mmHg of its baseline value for hypertensive patients.

  • And/or other signs of hemodynamic instability (tachycardia, mottling, oliguria, hyperlactatemia) :

  • In spontaneous ventilation and without ventilatory assistance.

  • Previously equipped with an arterial catheter.

干预措施: Detection of preload responders by a PLR test (Other)

Negative PLR test (PLR-)

  • Patient over 18 years old.

  • Hospitalized in intensive care.

  • For which the clinician in charge of the patient will need to predict the response to fluids and decide on a possible infusion of fluids, because of:

  • Acute circulatory failure with mean arterial pressure < 65mmHg or < 30mmHg of its baseline value for hypertensive patients.

  • And/or other signs of hemodynamic instability (tachycardia, mottling, oliguria, hyperlactatemia) :

  • In spontaneous ventilation and without ventilatory assistance.

  • Previously equipped with an arterial catheter.

干预措施: Detection of preload responders by a PLR test (Other)

结局指标

主要结局

Diagnostic performance of the decrease in Pulse Pressure Variation (PPV) during a Passive Leg Raising test (PLR) to predict preload responsiveness

时间窗: Day 1

To assess the diagnostic performance of the decrease in pulse pressure variation (PPV) during a passive leg raising test (PLR) to predict preload responsiveness in spontaneously breathing patients hospitalized in intensive care.

次要结局

  • Evaluate the diagnostic performance of the increase in pulse pressure (PP) during a PLR test to predict preload responsiveness(Day 1)
  • Compare PLR measurements other hemodynamic data(Day 1)

研究者

发起方
CHU de Reims
申办方类型
Other
责任方
Sponsor

研究点 (1)

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