RecruitingNot ApplicableNCT03831386

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

Sponsor

Johns Hopkins University

Enrollment

200 participants

Start Date

Jan 31, 2019

Study Type

INTERVENTIONAL

Conditions

Pleural Effusion

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria8

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
Histocytological proof of pleural malignancy
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 Criteria14

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
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

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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.