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ARMSTRONG - Air entRainMent vS sTandard tReatment in nOn-expandable luNG

RecruitingNAAges 18 Years - anyAllCambridge University Hospitals NHS Foundation Tru…
NCT06959719 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This is a randomised controlled trial evaluating whether controlled air introduction into pleural space (air entrainment) during pleural effusion drainage reduces pain, improves patient satisfaction, and facilitates more effective drainage in patients with non-expandable lung (NEL). NEL lung is a common complication in patients with malignant or chronic pleural effusions, where the lung fails to fully re-expand after fluid removal due to pleural disease or fibrosis. In these patients, drainage often creates excessive negative pressure within the pleural cavity, leading to pain, vasovagal episodes, early termination of drainage, and the need for repeated procedures. This study investigates a simple, safe, and low-cost intervention using a standard 3-way tap attached to the drainage system. By intermittently opening the tap to atmospheric air during drainage, air enters the pleural cavit

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adults aged 18 years or older with a suspected or confirmed diagnosis of NEL and persistent pleural effusion. * Patients who are scheduled for pleural effusion drainage as part of their standard care. * Ability to adequately understand verbal or written information in English and provide informed consent in English. Exclusion Criteria: * Patients with a history of pleurodesis or other procedures that may affect pleural dynamics. * Patients with active infections or other acute medical conditions that could interfere with the study. * Patient with multifactorial pain and high baseline score pain defined as VAS \>= 5 * Patients requiring IPC * Individuals with known contraindications to pleural drainage or air entrainment. * Patients who cannot provide informed consent in English, do not adequately understand verbal or written information in English or have special communication needs.
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What it tests

  • Air Entrainment - intentional introduction of the atmospheric air into the pleural space.
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Where

1 site
Addenbrooke's Hospital
Cambridge, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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