Clinical Trial: Safety and Efficacy of Real-time Ultrasound-Guided Seldinger Technique versus Pre-scan Marking for Small-Bore Chest Tube Insertion in the Intensive Care Unit: A Retrospective Cohort Study (Japan)

Tokyo, April 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061173) titled 'Comparative study of real-time ultrasound-guided versus conventional methods for pleural effusion treatment in the ICU' on April 10.

Study Type: Observational

Primary Sponsor: Institute - Aichi Medical University

Condition: Condition - Pleural effusion Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To retrospectively evaluate whether the real-time ultrasound-guided Seldinger technique significantly reduces procedure-related mechanical complications (pneumothorax, hemorrhagic complications, and organ injury) and improves catheter placement accuracy and oxygenation compared to the conventional pre-scan marking technique in adult ICU patients requiring small-bore chest tube insertion. Basic objectives2 - Safety

Eligibility: Age-lower limit - 20 years-old =20 years old) admitted to the ICU. To eliminate confounding by catheter size, the primary analysis cohort is restricted to cases using small-bore devices (<=12Fr). Key exclusion criteria - - Procedures performed outside the ICU. - [For Real-time group] Non-standard patient positioning or use of non-specified devices. - Pre-existing pneumothorax or suspected pre-existing hemothorax (trauma, post-CPR, acute aortic disease, etc.). - Patients under ECMO management with systemic anticoagulation. - Complex pleural effusions and lung abscesses with cavities. - [For Pre-scan group] Cases initially screened for the Pre-scan group but documented as "real-time ultrasound-guided" in medical records. Target Size - 160

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2026 Year 03 Month 26 Day Date of IRB - 2026 Year 04 Month 02 Day Anticipated trial start date - 2026 Year 05 Month 01 Day Last follow-up date - 2026 Year 05 Month 06 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070003

Disclaimer: Curated by HT Syndication.