Air Entrainment vs. Standard Treatment in Non-Expandable Lung With Persistent Pleural Effusion: A Randomised Controlled Double-Blind Trial

What this Trial Is About

This research aims to evaluate whether introducing controlled air into the pleural space during pleural effusion drainage reduces pain, improves patient satisfaction, and enhances drainage effectiveness in patients with non-expandable lung (NEL). NEL occurs when the lung cannot fully re-expand after fluid removal due to pleural disease or fibrosis, causing excessive negative pressure that leads to pain, vasovagal episodes, and early stopping of drainage, often requiring repeated procedures. This trial compares a simple, safe, and low-cost method of air entrainment to standard drainage care. The trial involves two groups: one receiving standard drainage care where fluid removal stops at the first sign of discomfort, and another receiving drainage with intermittent controlled air introduction via a standard 3-way tap attached to the drainage system. Air is introduced up to five times during the procedure based on patient discomfort and operator judgment to reduce the vacuum effect in the pleural cavity. The study is randomized in a 2:1 ratio favoring the air entrainment group, with both patients and outcome assessors blinded to treatment allocation. Participants will undergo therapeutic pleural drainage and have their pain levels measured using a Visual Analogue Scale (VAS) before, during, and after the procedure. Additional assessments include measuring the volume of fluid drained, the number and timing of drainage procedures needed, any complications, and patient satisfaction through questionnaires covering pre-, during, and post-procedure experiences. Follow-up will continue for up to six months to monitor outcomes and safety.

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