Gravity Versus Vacuum Based Indwelling Tunneled Pleural Drainage System
NCT ID: NCT03831386
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2019-01-31
2026-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Vacuum
The pleural fluid will be drained by the syringe system with a one-way valve tubing system provided in the kit. Selection of the vacuum pressure will be at the discretion of the proceduralist, as per standard of care. Participants in this arm will undergo Vacuum-Based IPC.
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.
Gravity
The pleural fluid will be drained using gravity drainage to a bag positioned at bedside. Participants in this arm will undergo Gravity-Based IPC.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
* 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
18 Years
ALL
No
Sponsors
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Rocket Medical plc
OTHER
Swedish Medical Center
OTHER
Medical University of South Carolina
OTHER
University of Oxford
OTHER
Vanderbilt University Medical Center
OTHER
Northwest Community Healthcare
UNKNOWN
Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Lonny Yarmus, DO
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Northwest Community Healthcare
Arlington Heights, Illinois, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Swedish Medical Center
Seattle, Washington, United States
University of Oxford
Oxford, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB00158671
Identifier Type: -
Identifier Source: org_study_id