Comparative study of real-time ultrasound-guided versus conventional methods for pleural effusion treatment in the ICU

Safety and Efficacy of the Real-Time Ultrasound-Guided Seldinger Technique versus Pre-Scan Marking for Small-Bore Thoracostomy in the Intensive Care Unit: A Retrospective Cohort Study - Real-time US vs Pre-scan for ICU Thoracostomy

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000061173

Enrollment

160

Registered

2026-04-10

Start date

2026-05-01

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pleural effusion

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All consecutive procedures for pleural drainage in patients with pleural effusion (>=20 years old) admitted to the ICU. To minimize confounding related to catheter size, the primary analysis cohort was restricted to procedures using small-bore devices (<=14 Fr). However, because only <=12-Fr small-bore devices were available at our institution during the study period, all procedures included in the primary analysis used devices of <=12 Fr.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Composite incidence of procedure-related mechanical complications (pneumothorax, hemorrhagic complications, and organ injury) within 24 hours post-procedure.	—

Secondary

Measure	Time frame
- Physiological efficacy at 24 hours post-procedure: Achievement rate of clinical improvement in oxygenation and total drainage volume. - Catheter placement accuracy: Success rate of optimal positioning based on post-procedural imaging (CT and chest X-ray). - Late-onset complications: Incidence of drain-related pleural infection from 48 hours post-procedure. - Clinical course and outcomes: Duration of drainage, ICU length of stay, and ICU mortality.	—

Measure

Time frame

- Physiological efficacy at 24 hours post-procedure: Achievement rate of clinical improvement in oxygenation and total drainage volume. - Catheter placement accuracy: Success rate of optimal positioning based on post-procedural imaging (CT and chest X-ray). - Late-onset complications: Incidence of drain-related pleural infection from 48 hours post-procedure. - Clinical course and outcomes: Duration of drainage, ICU length of stay, and ICU mortality.

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Countries

Japan

Contacts

Public ContactKento Nakamura

Aichi Medical University Department of Anesthesiology

nakamura.kento.163@mail.aichi-med-u.ac.jp0561-62-3311

Outcome results