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临床试验/NCT02569424
NCT02569424已完成不适用

Effect of PEEP and Trendelenburg on Ultrasound Size of Internal Jugular and Subclavian Veins: A Cross-over Randomized Controlled Study

University Hospital, Clermont-Ferrand2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2015年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
42
试验地点
2
主要终点
The cross-sectional area of the jugular veins ( in cm2)

研究概览

简要总结

There is no recommendation for the management of the positive end-expiratory pressure (PEEP) during setting of a central venous catheter (CVC) in a ventilated patient. Several non-randomized studies have investigated the cross-sectional area (AST) ultrasound minor axis for different pressure levels by evaluating a single vessel every time or by not displaying the right or left side in the evaluation. Another study showed that there could be unpredictable size differences between the 2 subclavian veins.

In ventilated patient, the PEEP, which is intrathoracic, will result in a decrease of venous return and thus possibly a superior vena cava dilation, located outside the pleura, depending on their capacitance. Different pressure levels showed an increase of AST with the increase of intra-thoracic pressure on certain veins, in a heterogeneous and not randomized manner.

The primary purpose of the study is to measure the effect of PEEP (0, 5, 10 or 15 cm H2O) and the patient's position (supine or Trendelenburg strict -15-20 °) on the cross-sectional area of the jugular and subclavian veins.

详细描述

There is no recommendation for the management of the positive end-expiratory pressure (PEEP) during setting of a central venous catheter (CVC) in a ventilated patient. Several non-randomized studies have investigated the cross-sectional area (AST) ultrasound minor axis for different pressure levels by evaluating a single vessel every time or by not displaying the right or left side in the evaluation. Another study showed that there could be unpredictable size differences between the 2 subclavian veins.

In ventilated patient, the PEEP, which is intrathoracic, will result in a decrease of venous return and thus possibly a superior vena cava dilation, located outside the pleura, depending on their capacitance. Different pressure levels showed an increase of AST with the increase of intra-thoracic pressure on certain veins, in a heterogeneous and not randomized manner.

The primary purpose of the study is to measure the effect of PEEP (0, 5, 10 or 15 cm H2O) and the patient's position (supine or Trendelenburg strict -15-20 °) on the cross-sectional area of the jugular and subclavian veins.

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

  • Any patient ventilated in intensive care is eligible.
  • Age ≥ 18 years
  • Patient with stable hemodynamic status and Mean Blood Pressure (< 65 mmHg)
  • Patient with registered social security number

排除标准

  • clinical sign for a central venous thrombosis (unilateral edema ...).during echography screening before inclusion
  • presence of a central line for more than 48 hours.
  • Anechoic patient (checked during echography screening)
  • History of cervical spine surgery.
  • IntraCranial HyperTension
  • patient in shock with hemodynamic instability and not stabilized
  • patient treated by noradrenaline > 1 µg/kg/min
  • patient or relative's refusal
  • protected patients ≥ 18 years, minors, pregnant women

结局指标

主要结局

The cross-sectional area of the jugular veins ( in cm2)

时间窗: at baseline

The cross-sectional area of the jugular veins ( in cm2) at the end of the intervention

次要结局

  • The cross-sectional area of the subclavian veins ( in cm2)(at baseline)
  • The antero-posterior diameter of the jugular veins (in mm)(at baseline)
  • The antero-posterior diameter of the subclavian veins (in mm)(at baseline)
  • The distance between posterior and pleural lining of the jugular veins (in mm)(at baseline)
  • The distance between posterior and pleural lining of the subclavian veins (in mm)(at baseline)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (2)

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