跳至主要内容
临床试验/NCT06285331
NCT06285331招募中不适用

the Impact of Manual or Mechanical Ways to Perform Passive Leg Raising on the Accuracy of Evaluation of Fluid Responsiveness

Southeast University, China1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年11月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Accuracy of fluid responsiveness evaluation

研究概览

简要总结

Our goal was to study the impact of different ways to perform passive leg raising (PLR) on the accuracy of evaluation of fluid responsiveness.

详细描述

Patients who have shock of all kinds of reasons usually need to be transferred to the Intensive Care Unit(ICU) for monitoring and treatment due to unstable vital signs and high fatal risks. The cardiac function of these patients requires special attention. Fluid responsiveness is a comprehensive reflection of preload and cardiac function, which provides guidance on how to conduct fluid replacement therapy. When patients have fluid responsiveness, it means that after fluid resuscitation therapy, the patients' cardiac output will increase and tissue perfusion will improve, bringing benefits to patients themselves. Therefore, it is of vital significance to evaluate the presence of fluid responsiveness in patients before fluid therapy in clinical practice. Passive leg raising(PLR) is a commonly used method in clinical practice to evaluate patients' fluid responsiveness. But its accuracy is affected by the way the leg lifting is performed.

This project is aimed to explore the impact of different ways to perform passive leg raising on the accuracy of evaluation of fluid responsiveness.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • (1) patients who have signs of tissue hypo-perfusion (increasing lactate levels, in need of vasopressor agents to maintain blood pressure, oliguria, and weak consciousness), and need to evaluate their fluid responsiveness; (2) patients who have received Pulse indicator Continuous Cardiac Output (PiCCO) monitoring ; (3) patients who are transferred into the intensive care department.

排除标准

  • (1) Age < 18 years old, or > 75 years old (2) pregnancy or lactation; (3) refusal to sign the informed consent form for enrollment; (4) patients who are clearly unable to perform passive leg raising (PLR) (intra-abdominal pressure ≥16cmH2O, high risk of lower limb venous thrombosis, intracranial hypertension, and recent undergone abdominal or pelvic surgery); (5) patients with the contraindications of fluid resuscitation therapy ( pulmonary edema, intracranial hypertension and so on); (6) patients clinical doctors assessed as unsuitable for PLR.

结局指标

主要结局

Accuracy of fluid responsiveness evaluation

时间窗: Immediately after procedure

It is the results of accuracy of evaluation of patients' fluid responsiveness by performing PLR by different ways. The accuracy is evaluated by comparing the results of PLR and fluid challenge test. The cardio output of patients is obtained by Pulse indicator Continuous Cardiac Output (PiCCO). The results of PLR are considered accurate if the results of the patient's volume responsiveness measured by different methods of PLR are consistent with the results obtained by the fluid challenge test.

次要结局

  • Mortality(90days)

研究者

发起方
Southeast University, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jingyuan,Xu

Zhongda Hospital

Southeast University, China

研究点 (1)

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