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临床试验/NCT04001179
NCT04001179终止不适用

Exploratory Metabolomics Study of Exhaled Breath in Pulmonary Embolism

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2021年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
1
试验地点
1
主要终点
quantitative comparison of metabolic profiles

研究概览

简要总结

Pulmonary embolism is a frequent and recurrent pathology, especially in the elderly. It is often preventable, with high mortality and morbidity, making it a major public health issue. The clinical presentation of pulmonary embolism is non-specific and very highly variable, ranging from asymptomatic thrombus diagnosed incidentally to sudden death. The current diagnosis of pulmonary embolism is based on several diagnostic techniques, mainly non-invasive, which should be used sequentially.

We propose to sample the volatile organic compounds using a device that allows them to be trapped on polymer cartridges. Sampling will be performed under monitoring of respiratory pressure and a capnograph to collect alveolar and upper respiratory tract air separately without contamination of the oral cavity or sinuses.

This exploratory metabolic analysis will be non-targeted (analysis of all molecules detectable without a priori).

The main objective of the study is to identify specific metabolic profiles to predict the results of ventilation-perfusion pulmonary tomoscintigraphy in subjects undergoing this examination for suspected acute pulmonary embolism.

Secondary purposes :

  • To identify metabolic profiles to be used to predict, in combination with clinical probability scores, the results of ventilation-perfusion pulmonary tomoscintigraphy in subjects undergoing this examination for suspected acute pulmonary embolism.;
  • To correlate metabolic profiles with the topography of embolized lung territories

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

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

  • Male or female, at least 18 years old
  • Patients with clinical suspected pulmonary embolism
  • Patient willing and able to provide informed consent

排除标准

  • Contraindications to pulmonary ventilator-perfusion tomoscintigraphy
  • All types of thrombolytic or anticoagulant treatment
  • Diagnosis of pulmonary embolism established prior to inclusion in the study
  • Massive pulmonary embolism (systolic pressure < 90 mm Hg)
  • Pregnancy
  • Breastfeeding

结局指标

主要结局

quantitative comparison of metabolic profiles

时间窗: Metabolites are collected immediately before pulmonary tomoscintigraphy

The quantitative variables compared between the two "contributive" groups are the relative quantities of volatile organic compounds (metabolites) detected by chromatographic techniques coupled with mass spectrometry in exhaled air samples.

次要结局

  • Wells score or revised Geneva score(Clinical scores are collected immediately before pulmonary tomoscintigraphy)
  • number and location of deficient segments on ventilation-perfusion pulmonary tomoscintigraphy.(day 1)

研究者

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

研究点 (1)

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