跳至主要内容
临床试验/NCT07261956
NCT07261956招募中不适用

Usefulness of Lung Ultrasound for the Detection of Volume Overload in Patients With Severe Preeclampsia

Saint Thomas Hospital, Panama1 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2025年8月25日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
202
试验地点
1
主要终点
Lung Ultrasound evaluation

研究概览

简要总结

This research aims to evaluate the usefulness of lung ultrasound (LUS) for detecting and monitoring fluid overload in patients with severe preeclampsia. Severe preeclampsia is a leading cause of maternal death and illness worldwide, often causing fluid buildup that can lead to a serious complication called pulmonary edema, especially after delivery.

The study will be a prospective, longitudinal observational study with a diagnostic validation component. It will involve patients with a diagnosis of severe preeclampsia who meet specific inclusion criteria. Each participant will undergo a clinical exam and a lung ultrasound, which will assess eight zones of the lungs. The total number of B-lines-a sign of interstitial edema-will be documented.

Data will be collected at three key times: upon admission, in the immediate postpartum period (within 24 hours of delivery), and 7-10 days postpartum. The results from the LUS will be compared to clinical signs like shortness of breath, rapid breathing, crackling sounds in the lungs, and oxygen saturation levels.

The expected impact of this research is to provide evidence that LUS is a valuable, non-invasive, and accessible tool for the early detection of pulmonary congestion in patients with severe preeclampsia. This could lead to improved clinical decision-making and a reduction in maternal respiratory complications.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • Preeclampsia with severe features.
  • Gestational age 24 weeks - 41 weeks.

排除标准

  • Chronic lung disease.
  • Known heart disease.
  • Diagnosis of lung edema at admission
  • Body mass index > 40
  • Need for immediate delivery

结局指标

主要结局

Lung Ultrasound evaluation

时间窗: One evaluation at admission, another one just before delivery and a final one 24 hours after delivery

Three or more B Lines in at least two lung zones using lung ultrasound

次要结局

  • Dyspnea(Report of the symptom by the patient from admission for up to three days)
  • Tachypnea(Report of the symptom from admission for up to three days.)
  • Oxygen saturation(Report of the value measured by a pulse oxymeter from admission for up to three days)

研究者

发起方
Saint Thomas Hospital, Panama
申办方类型
Other
责任方
Principal Investigator
主要研究者

Osvaldo A. Reyes T.

Head of Research Department

Saint Thomas Hospital, Panama

研究点 (1)

Loading locations...

相似试验

Lung Ultrasound for the Detection of Volume Overload... | 临床试验