跳至主要内容
临床试验/NCT05694806
NCT05694806招募中不适用

Clinical Impact of Thoracic Scanographic Characteristics of Hematologic Malignancy Patients With Mediastinal Mass Syndrome Admitted to the Intensive Care Unit

University Hospital, Toulouse1 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
125
试验地点
1
主要终点
To identify prognostic thoracic scan factors of severe mediastinal mass syndrome

研究概览

简要总结

The mediastinum can be the site of benign or malignant tumors, including 10 to 20% of hematological malignancies.

Mediastinal mass syndrome (MMS) includes symptoms due to irritation, invasion or compression of the organs of the mediastinum. This syndrome includes respiratory manifestations that may be secondary to compression of the tracheobronchial tree, venous vascular manifestations with the superior vena cava syndrome or arterial manifestations, cardiac manifestations, digestive or nervous manifestations.

The management of a mediastinal syndrome is a diagnostic and therapeutic emergency requiring the collaboration of several disciplines in order to achieve the most effective but least deleterious way possible to diagnostic imaging, etiological biopsy, and the possible implementation of life-saving symptomatic measures before the initiation of etiological treatment.

Diagnostic thoracic imaging relies primarily on thoracic computed tomography (CT) to determine the size and nature of the mediastinal mass, the presence and extent of tracheobronchial or great vessel compression, the presence of pleural and/or pericardial effusion, pulmonary embolism, parenchymal lesions, and possibly subdiaphragmatic lesions.

However, the potential severity of MMS is often under-diagnosed in adult patients, particularly in the context of hematologic malignancy. Indeed, we have very little literature on the initial management of these patients at risk.

The present study propose to conduct the first multicenter study to analyze the characteristics (clinical, scanographic, echocardiographic, hematological and resuscitation) of the initial management of patients with symptomatic MMS at diagnosis or at relapse of a patient with MH admitted to the Intensive Care Unit (ICU).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hematologic malignancy at diagnosis or relapse
  • Symptomatic mediastinal mass syndrome
  • Admission to the ICU, Continuous Medical Surveillance (CMS) or Intensive Care (IC) for symptomatology related to MMS
  • Chest CT (after maximum 48 hours of corticosteroid therapy (1mg/kg/ Prednisone equivalent), maximum 15 days before and 5 days after admission to ICU)
  • Maximum administration of corticosteroid therapy 48 hours before admission to the ICU (maximum 1mg/kg/ Prednisone equivalent)
  • No prior pleural or pericardial drainage
  • Study period: 01/01/2014 - 31/12/2021 (8 years)

排除标准

  • No diagnosis of hematologic malignancy
  • Diagnosis of solid benign or malignant tumor
  • No mediastinal mass syndrome
  • No admission to ICU/CMS
  • No chest CT scan meeting inclusion criteria
  • Administration of corticosteroids for more than 48 hours prior to admission to the ICU and/or prior to chest CT
  • Lack of social security affiliation.

结局指标

主要结局

To identify prognostic thoracic scan factors of severe mediastinal mass syndrome

时间窗: 1 week

To identify prognostic thoracic scan factors of severe mediastinal mass syndrome defined by the occurrence of severe respiratory, hemodynamics and/or neurological failures.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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