Gravity Versus Vacuum Based Indwelling Tunneled Pleural Drainage System

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.

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 than 60 days) thoracic surgery or chest trauma causing chronic pain

- Pregnant or lactating mothers

- Previous ipsilateral chemical pleurodesis

- Current contralateral indwelling pleural catheter

- Known rib or thoracic skeletal metastasis causing pain

- Concern for active pleural infection

- Respiratory failure

- Irreversible bleeding diathesis

- Inability to provide care for indwelling tunneled pleural catheter

- Significantly loculated pleural space precluding drainage of pleural space, for which
IPC alone will likely not offer symptomatic benefit

- Estimated life expectancy of < 30 days (however, active enrollment in hospice program
is not an exclusion criteria)

- Inability to read/understand/write in the English language

- Inability to follow-up for appointments/protocol

- Subject has any clinical condition, diagnosis, or social circumstance that, in the
opinion of the investigator would mean participation in the study would be
contraindicated.

- Enrollment in alternative pleural catheter trial that would preclude enrollment within
this trial