The Impact of a Gravity Versus Vacuum Based Indwelling Tunneled Pleural Drainage System on Pain: A Multicenter, Randomized Trial
Johns Hopkins University
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.
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 pot…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Clinical indications for placement of IPC for malignant pleural effusion a. Pleural effusion with symptomatic improvement in dyspnea after drainage of ipsilateral effusion * Clinically confident symptomatic malignant pleural effusion 1. Histocytological proof of pleural malignancy 2. Recurrent large pleural effusion in context of histologically proven cancer outside the pleural space * Plans for placement of IPC within ten days of enrollment * Age \> 17 years * Sufficient fluid on ultrasound to allow for safe insertion of IPC Exclusion Criteria: * Recent (less…
Interventions
- ProcedureVacuum-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.
- ProcedureGravity-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.
Locations (6)
- Northwest Community HealthcareArlington Heights, Illinois
- Johns Hopkins HospitalBaltimore, Maryland
- Medical University of South CarolinaCharleston, South Carolina
- Vanderbilt University Medical CenterNashville, Tennessee
- Swedish Medical CenterSeattle, Washington
- University of OxfordOxford