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临床试验/NCT07273617
NCT07273617已完成不适用

Effects of Positive End-Expiratory Pressure (PEEP) and Prone Positioning in Healthy Volunteers on Venous Hemodynamics Including the Venous Excess Ultrasound (VExUS) Score

University Hospital, Basel, Switzerland3 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年9月25日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
3
主要终点
Change in VExUS score at 0, 5,10 and 15 mbar during non-invasive ventilation (NIV) in the supine position.

研究概览

简要总结

The hemodynamic effects of proning and PEEP may vary depending on pre- existing cardiac function, lung mechanics, and volume status, and the available evidence remains conflicting. The impact on the VExUS score of these manoeuvres is unclear. This study aims to assess the effects of PEEP in supine and prone position on the VExUS score as well as echocardiographic parameters in a cohort of healthy volunteers.

详细描述

Venous congestion: characterized by elevated venous pressure and impaired flow through the organs towards the right heart, contributes to organ dysfunction and is associated with adverse outcomes in critically ill patients. Historically, hemodynamic assessment has focused on the arterial side of circulation, giving less attention to venous hemodynamics. However, there is growing evidence that venous congestion is a mediator of adverse outcomes and contributes to end-organ damage. With increasing venous congestion, subsequent venous distension in the splanchnic circulation occurs and the pressure waveform of the right atrium is retrogradely transmitted into the distal venous circulation. The more venous congestion is present, the more pulsatility is transmitted into the periphery. This represents the backbone of the venous excess ultrasound (VExUS) score assessment. The VExUS score assessment therefore represents a multi-organ Doppler approach evaluating venous congestion by measuring the inferior vena cava (IVC) diameter, flow pattern of hepatic veins, portal vein and intra-renal veins by ultrasound.

Heart lung interactions and implications on VExUS: the VExUS score as well as femoral and jugular vein flows are expected to be affected by positive pressure ventilation. The VExUS score correlates with the Mean systemic filling pressure (MSFP) as a surrogate for stressed volume, in other words the proportion of blood which contributes to creating pressure and blood flow. As right atrial pressure is influenced by Positive End-Expiratory Pressure (PEEP), one would expect elevated VExUS Scores with higher PEEP levels.

Influence of position on hemodynamics: conflicting effects on the circulatory system mediated by prone positioning have been described; no data about VExUS Score assessment in prone position is available.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
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

  • Voluntary participants ≥ 18 years in good overall health with no relevant organ dysfunction in their medical history and signed informed consent form.

排除标准

  • Non-French or non-German speakers
  • Unable to provide informed consent
  • Body mass index > 40kg/m
  • Self-reported pregnancy
  • History of pneumothorax
  • Previously participated in the study

研究组 & 干预措施

1. Supine position 2. Prone Position

Experimental

First body position: randomized to supine position. Randomization of starting PEEP (0 or 15 mbar) in first body position and sequence of measurements.

Second body position: Prone Position. Randomization of starting PEEP (0 or 15 mbar) in second body position and sequence of measurements.

干预措施: application of PEEP: starting PEEP = 0 mbar (Diagnostic Test)

1. Supine position 2. Prone Position

Experimental

First body position: randomized to supine position. Randomization of starting PEEP (0 or 15 mbar) in first body position and sequence of measurements.

Second body position: Prone Position. Randomization of starting PEEP (0 or 15 mbar) in second body position and sequence of measurements.

干预措施: application of PEEP: starting PEEP = 15 mbar (Diagnostic Test)

1. Prone Position 2. Supine Position

Experimental

First body position: randomized to prone position. Randomization of starting PEEP (0 or 15 mbar) in first body position and sequence of measurements.

Second body position: Supine Position. Randomization of starting PEEP (0 or 15 mbar) in second body position and sequence of measurements.

干预措施: application of PEEP: starting PEEP = 15 mbar (Diagnostic Test)

1. Prone Position 2. Supine Position

Experimental

First body position: randomized to prone position. Randomization of starting PEEP (0 or 15 mbar) in first body position and sequence of measurements.

Second body position: Supine Position. Randomization of starting PEEP (0 or 15 mbar) in second body position and sequence of measurements.

干预措施: application of PEEP: starting PEEP = 0 mbar (Diagnostic Test)

结局指标

主要结局

Change in VExUS score at 0, 5,10 and 15 mbar during non-invasive ventilation (NIV) in the supine position.

时间窗: up to 15 min

The Venous excess ultrasound (VExUS) score is a grading system that uses ultrasound to non-invasively assess and quantify systemic venous congestion by evaluating the inferior vena cava, hepatic veins, portal veins, and renal veins. A patient receives a grade from 0 (no congestion) to 3 (severe congestion) based on findings like IVC diameter and Doppler waveforms from the veins.

次要结局

  • Change in VExUS score at 0, 5,10,15 mbar during non-invasive ventilation in the prone position compared to the supine position.(up to 15 min)

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (3)

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