Impact of Patient Position on Chemical Pleurodesis by Chest Ultrasound

Обзор

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

Подробное описание

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.

Вмешательства

• Другое side to side and front to back rotation 30 minutes each
  side to side and front to back rotation 30 minutes each after pleurodesis

Первичные конечные точки

• Measurement of pleural adhesion score in patients with malignant pleural effusion candidates for pleurodesis in group with rotation and the other without rotation [Срок оценки: immediatly and after one month from pleurodesis]

Вторичные конечные точки (1)

• Measurement of non-verbal Pain score in patients with malignant pleural effusion candidates for pleurodesis in group with rotation and the other without rotation [Срок оценки: immediately after pleurodesis]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Египет · 1 центр

• Ain Shams university — Cairo

Идентификаторы

NCT: NCT07147270 · FMASU R107/2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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