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临床试验/NCT03066414
NCT03066414已完成不适用

Respiratory Variations in Diameters of the Inferior Vena Cava and the Internal Jugular Vein to Assess Blood Withdrawal in Patients With Genetic Hemochromatosis

University Hospital, Lille1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2015年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
27
试验地点
1
主要终点
blood withdrawal-induced changes in the respiratory variations of the inferior vena cava during a standardized respiratory maneuver (ΔIVCST)

研究概览

简要总结

OBJECTIVES: To investigate whether respiratory variations of the inferior vena cava (ΔIVC) and internal jugular vein (ΔIJV) diameters during standardized breathing (ΔIVCST and ΔIJVST) increase after a therapeutic bleeding in spontaneously breathing and non-obese patients with genetic hemochromatosis.

DESIGN: Prospective, monocentric study in the EFS Nord-de-France blood center.

PATIENTS: Non-obese patients with genetic hemochromatosis undergoing a therapeutic bleeding.

INTERVENTIONS: Ultrasound measures and collected clinical parameters before and after a therapeutic bleeding, during a standardized respiratory maneuver.

MAIN OUTCOME AND MEASURES: The primary endpoint was the ΔIVCST change induced by a 300 to 500ml therapeutic bleeding. It measured the minimal and maximal IVC and IJV diameters during a standardized respiratory maneuver. ΔIVCST and ΔIJVST were calculated as follows: [(maximal diameter - minimal diameter)/maximal diameter].100.

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
否

入选标准

  • •adult patients of > or equal 18 years
  • •genetic hemochromatosis
  • •undergoing a therapeutic blood withdrawal
  • •health insured
  • •non-obese (body mass index <30Kg/m²)

排除标准

  • •pregnancy
  • •transthoracic echogenicity unsuitable for measuring the inferior vena cava diameters
  • •clinical signs of active exhalation

结局指标

主要结局

blood withdrawal-induced changes in the respiratory variations of the inferior vena cava during a standardized respiratory maneuver (ΔIVCST)

时间窗: during a standardized respiratory maneuver, an average 1 hour maximum

The primary endpoint was the ΔIVCST change induced by a 300 to 500ml therapeutic bleeding. The investigators measured the minimal and maximal IVC diameters during a standardized ventilation. ΔIVCST was calculated as follows: \[(maximal diameter - minimal diameter)/maximal diameter\].100.

次要结局

  • blood withdrawal-induced changes in the respiratory variations of the internal jugular vein during a standardized respiratory maneuver (ΔIJVST)(during a standardized respiratory maneuver, an average 1 hour maximum)

研究者

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

研究点 (1)

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