NCT03831386

Gravity Versus Vacuum Based Indwelling Tunneled Pleural Drainage System

The Impact of a Gravity Versus Vacuum Based Indwelling Tunneled Pleural Drainage System on Pain: A Multicenter, Randomized Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Malignant pleural effusion remains a debilitating complication of end stage cancer, which can be greatly improved by the introduction of the indwelling tunneled pleural catheter (IPC). However, there is no standard of care regarding drainage and limited data on the utility of different drainage techniques. In addition, many patients develop discomfort and chest pain during drainage. The investigators propose to evaluate gravity drainage and suction drainage on quality of life measures and outcomes.

Detailed description

Indwelling tunneled pleural catheters (IPCs) are used to alleviate pleural effusion as a first-line therapeutic (albeit palliative) intervention. Limited data currently exists on drainage techniques and the impact the techniques may have on quality of life. Current recommendations for IPC drainage range from daily drainage to once a week drainage, as well as only when needed for dyspnea. It has been theorized that active drainage of effusions may have an impact on the development of chest discomfort/pain, whereas passive regimens may allow for more gradual intrathoracic pleural changes and potentially offer a difference in drainage discomfort. The objective of this investigation is to compare different drainage strategies of indwelling pleural catheters (IPCs) regarding patient quality of life and outcomes. Patients will undergo placement of a pleural catheter as per standard institutional protocol. Patients will be randomized on a 1:1 basis into the suction drainage (active) arm or the gravity drainage (passive) arm. Patients will receive follow-up at two weeks, four weeks, twelve weeks and then as needed post IPC placement per standard clinical protocol. All patients will be asked to fill out quality of life questionnaires and update drainage diary information with patient's providers. Patients will undergo standard care treatment throughout the disease course and no different interventions regarding the pleural disease will be performed as a result of enrollment within this study. Study interventions/procedures will consist of questionnaires and patient self-reported documentation regarding patient's care and outcomes.

Conditions

• Pleural Effusion

Interventions

Type	Name	Description
PROCEDURE	Vacuum-Based IPC	An indwelling pleural catheter is placed inside the chest cavity to drain fluid from around the lungs. One end remains inside the body while the other drains via suction.
PROCEDURE	Gravity-Based IPC	An indwelling pleural catheter is placed inside the chest cavity to drain fluid from around the lungs. One end remains inside the body while the other drains via gravity.

Timeline

• Start date: 2019-01-31
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2019-02-05
• Last updated: 2025-12-17

Locations

6 sites across 2 countries: United States, United Kingdom