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临床试验/NCT06755385
NCT06755385尚未招募不适用

Pilot Study on the Value of Bedside Pleuropulmonary Ultrasound in Patients With Sickle Cell Disease Presenting With Vaso-occlusive Crisis.

University Hospital, Grenoble0 个研究点目标入组 25 人开始时间: 2025年1月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
25
主要终点
Description of the proportion of patients with sickle cell disease in vasoocclusive crisis presenting at least one pleuropulmonary ultrasound abnormality at D0, between D2 and D5 during hospitalization and at D-1 of discharge.

研究概览

简要总结

Describe the proportion of patients with major sickle cell syndrome in vaso-occlusive crisis presenting at least one pleuropulmonary ultrasound abnormality during one of the ultrasounds performed at D0, between D2 and D5 during hospitalization and at D-1 of discharge.

We hypothesize that pleuropulmonary ultrasound will make it possible to detect the serious complications associated with vaso-occlusive crises in patients with major sickle cell syndrome earlier and more reliably, in departments where ultrasound tools are still underdeveloped, while avoiding the need for more conventional radiology examinations that cause radiation in multi-hospitalized patients.

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

入选标准

  • Patient agreeing to participate in the study
  • Patient with sickle-cell disease consulted to the emergency department or hospitalized in a conventional internal medicine department for a clinical picture of severe vaso-occlusive crisis (CVO) requiring hospitalization.
  • Hospitalization in the internal medicine department
  • Possible re-inclusion in the event of a subsequent episode of severe CVO

排除标准

  • Subject under guardianship or subject deprived of freedom.
  • Primary acute chest syndrom (not following a crisis)
  • Pulmonary pathologies interfering with pleuro-pulmonary echo analysis: pneumonectomy, pulmonary fibrosis.

结局指标

主要结局

Description of the proportion of patients with sickle cell disease in vasoocclusive crisis presenting at least one pleuropulmonary ultrasound abnormality at D0, between D2 and D5 during hospitalization and at D-1 of discharge.

时间窗: 30 days

Presence of abnormalities found during pleuropulmonary ultrasound scans performed in the medical department on D0, between D2 and D5 during hospitalization and on D-1 of discharge, in patients with major sickle cell syndrome presenting with vasoocclusive crisis, among the following: * Pulmonary condensations; * Pleural effusion: minimal, of moderate abundance (estimated volume \< 500mL) or of great abundance (estimated volume \> 500mL); * Confluent B lines (≥ 3 B lines per lung field).

次要结局

  • Evaluate the association between the ultrasound image and the clinical picture(30 days)
  • Evaluate the association between the ultrasound image detected and the occurrence of acute chest syndrom.(30 days)
  • Evaluate the association between the ultrasound image detected and the severity of the acute chest syndrom(30 days)
  • Describe the evolution of abnormalities between visits at D0, between D2 and D5 (V1 and V2) during hospitalization and at D-1 of discharge, and their association with clinical evolution(30 days)
  • Assess the prognostic value of discharge pleuropulmonary ultrasound in relation to re-hospitalization, occurrence of acute chest syndrom or early mortality (within 30 days)(30 days)

研究者

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

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