Utility of Balloon Application during Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA): A Randomized controlled trial (RCT)

This study is a randomized, parallel group, single center with study setting being bronchoscopy suite, Department of pulmonary medicine, AIIMS Delhi. Trial will compare ultrasound image quality on VAS 0-100 scale along with successful needle aspiration between groups with balloon inflation during EBUS TBNA procedure and no balloon inflation during procedure. Trial will run for a period of 2 years with expected sample size of around 140 participants. Primary outcomes of study will be to determine the difference in Ultrasound Image Quality during EBUS, between the intervention and the control arm using VAS 1-100 scale and Proportion of subjects undergoing successful needle aspiration i.e. three adequate passes from the intended lymph node station/stations, between the groups. Secondary outcomes will be difference in Sample Adequacy between the intervention and the control arm. To compare the Overall operator rated procedure satisfaction between the intervention and the control arms using VAS 0-100 scale and lastly difference in the Complications rate of the procedure between the intervention and the control arm. Study will help to study clinical impact of balloon inflation on image quality and procedural outcomes during EBUS TBNA procedure.