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临床试验/NCT07147270
NCT07147270招募中不适用

Impact of Patient Position on Chemical Pleurodesis by Chest Ultrasound

Ain Shams University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年5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
30
试验地点
1
主要终点
Measurement of pleural adhesion score in patients with malignant pleural effusion candidates for pleurodesis in group with rotation and the other without rotation

研究概览

简要总结

chemical pleurodesis using doxycycline is an acceptable and commonly employed palliation for malignant pleural effusion. Rotation of patient during pleurodesis using the powder from doxycycline capsule is still practiced in some centers. The benefit of rotation practice in pleurodesis can be verified after properly designed study on the outcome of pleurodesis with rotation and non-rotation by chest ultrasound assessment

详细描述

Pleurodesis through thoracoscopy could be done if the pleura appears abnormal on direct inspection thus offers diagnostic and therapeutic procedures in a single sitting. Talc is considered the best known sclerosing agent especially when used by medical thoracoscopy/pleuroscopy (MT/P). Unfortunately, a serious complication can occur with its use. Graded talc,which is the safest form is not available in many developing countries, including Egypt. Also, injectable tetracyclines' synthesis has been ceased worldwide.

Meanwhile, the oral forms of doxycycline are readily available, inexpensive and as effective as its parenteral forms in inducing pleurodesis. Therefore it will be used, aiming to assess the efficacy, safety and outcome of pleurodesis with and without patient rotation using doxycycline in malignant pleural effusion. Rotation of patients during tetracycline pleurodesis has been a common practice even at the moment. However, it had been proven that intrapleural instillation of parental tetracycline, a water soluble substance, to achieve chemical pleurodesis does not require rotation of patients as the tetracycline is distributed completely throughout the pleural space within seconds, and the distribution is not enhanced by patient's rotation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients who will be admitted at Chest department, Ain-Shams University Hospitals with malignant pleural effusions candidate for pleurodesis

排除标准

  • Multiloculated fluid
  • Previous failed pleurodesis
  • Liver failure
  • Renal failure
  • Congestive heart failure
  • Prolonged use of steroids or NSAIDs
  • Refusal to participate

结局指标

主要结局

Measurement of pleural adhesion score in patients with malignant pleural effusion candidates for pleurodesis in group with rotation and the other without rotation

时间窗: immediatly and after one month from pleurodesis

study how patient rotation after pleurodesis affects its success by measuring pleural adherence score by chest ultrasound, a higher adhesion score means successful pleurodesis

次要结局

  • Measurement of non-verbal Pain score in patients with malignant pleural effusion candidates for pleurodesis in group with rotation and the other without rotation(immediately after pleurodesis)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

hieba gamal ezz-elragal awad

Assistant professor

Ain Shams University

研究点 (1)

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