Gravity Versus Vacuum Based Indwelling Tunneled Pleural Drainage System

Description

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.

Conditions

Pleural Effusion

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Study Overview

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Study Details

Study overview

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.

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

Gravity Versus Vacuum Based Indwelling Tunneled Pleural Drainage System

Condition
Pleural Effusion
Intervention / Treatment

-

Contacts and Locations

Arlington Heights

Northwest Community Healthcare, Arlington Heights, Illinois, United States, 60005

Baltimore

Johns Hopkins Hospital, Baltimore, Maryland, United States, 21287

Charleston

Medical University of South Carolina, Charleston, South Carolina, United States, 29425

Nashville

Vanderbilt University Medical Center, Nashville, Tennessee, United States, 37232

Seattle

Swedish Medical Center, Seattle, Washington, United States, 98104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Clinical indications for placement of IPC for malignant pleural 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Johns Hopkins University,

Lonny Yarmus, DO, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

2026-12-31