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临床试验/NCT04023786
NCT04023786已完成不适用

Positive End-expiratory Pressure Effects to Predict Fluid Responsiveness

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2019年12月13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
入组人数
66
试验地点
2
主要终点
Ability of the PEP test to detect a preload-dependency condition.

研究概览

简要总结

Volume expansion is one of the main treatments for shock. A test to predict the effectiveness of volume expansion prior to administration would avoid the need for excess treatment if it proves to be unnecessary.PEEP test would be an easy alternative to the tests used in current practice.

详细描述

Volume expansion is one of the main treatments for shock, with the goal of increasing cardiac preload and, consequently, cardiac output. However, this increase only occurs if there is a preload-dependence of cardiac output, which is present in 50% of cases. A test to predict the effectiveness of volume expansion prior to administration would avoid the need for excess treatment if it proves to be unnecessary. The end-expiratory pressure test (PEEP) would be to vary the PEEP in patients in shock conditions placed under mechanical ventilation. PEEP is the positive pressure maintained in the airways at the end of expiration. It opposes systemic venous return and lowers cardiac preload. It also distends the pulmonary vessels, increases their resistance and opposes the ejection of the right ventricle. The decrease in PEEP could alleviate the obstacle to venous return and thus increase cardiac preload, mimicking a volume expansion, increasing cardiac output only in the case of preload dependence. This test would be an easy alternative to the tests used in current practice. To evaluate the ability of the PEEP test to detect a preload-dependence condition, defined by a passive passive leg raising test, in patients in shock.

The primary endpoint will be the area under the receiver operating characteristic (ROC) curve constructed to describe the ability of the PEEP test to detect a preload-dependency condition. We measure cardiac output by analysis of the pulse wave contour before and after the passive leg raising and PEEP test tests, then according to these tests, measurement of the cardiac output before and after volume expansion.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
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

  • Age ≥ 18 years
  • Coverage by a health insurance scheme
  • Patient under mechanical invasive ventilation (tracheal intubation)
  • PEEP level ≥10 cmH2O
  • Cardiac flow monitoring device in place by the PiCCO2 system (Pulsion Medical Systems, Feldkirch, Germany).
  • Ikorus urinary catheter in place
  • Decision by the doctors in charge of carrying out a passive leg raising test and / or a volume expansion

排除标准

  • Pregnancy
  • Participation in another interventional study
  • Patients under the protection of justice
  • Thoracic drainage (preventing PEP changes from inducing intrathoracic and transpulmonary pressure changes from their hemodynamic effects).

研究组 & 干预措施

70 patients, one arm

Experimental

All patients benefits of a passive leg raising test and a PEEP test to compare these two tests.

干预措施: PEEP-TEST (Procedure)

70 patients, one arm

Experimental

All patients benefits of a passive leg raising test and a PEEP test to compare these two tests.

干预措施: The VenArt System (Device)

结局指标

主要结局

Ability of the PEP test to detect a preload-dependency condition.

时间窗: At the end of the hospitalization in intensive care unit (1 month maximum)

The primary endpoint will be the area under the receiver operating characteristic (ROC) curve constructed to describe the ability of the PEP test to detect a preload-dependency condition.

次要结局

  • Relationship between the ability of the PEEP test to detect a preload-dependancy and secondly the PEEP delta induced by the test(At the end of the hospitalization in intensive care unit (1 month maximum))
  • Ability of the PEP test to detect a response to volume expansion.(At the end of the hospitalization in intensive care unit (1 month maximum))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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