Actively Recruiting
The Impact of a Gravity Versus Vacuum Based Indwelling Tunneled Pleural Drainage System on Pain: A Multicenter, Randomized Trial
Led by Johns Hopkins University · Updated on 2025-12-17
200
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
R
Rocket Medical plc
Collaborating Sponsor
AI-Summary
What this Trial Is About
Malignant pleural effusion is a serious complication in end-stage cancer patients that can greatly affect quality of life. Researchers are evaluating two different drainage methods for indwelling tunneled pleural catheters (IPCs) to see how they impact patient comfort and outcomes. The study compares active suction drainage to passive gravity drainage to understand which approach better manages symptoms like chest pain and discomfort during fluid removal. Participants will have a pleural catheter placed according to standard medical practice. They will be randomly assigned to either the vacuum-based IPC group, where fluid is actively suctioned using a syringe system with adjustable vacuum pressure, or the gravity-based IPC group, where fluid drains passively into a bedside bag. Follow-up visits will occur at two, four, and twelve weeks after catheter placement, with additional visits as needed based on clinical care. During the study, patients will complete quality of life questionnaires and keep drainage diaries to report their experiences. Researchers will assess chest pain daily for up to two weeks using a visual scale and track changes in pain, health status, and breathing function over twelve weeks. The study focuses on patient-reported outcomes and standard clinical follow-up, without altering other treatments for pleural disease throughout the course of their illness.
CONDITIONS
Brief Title
Gravity Versus Vacuum Based Indwelling Tunneled Pleural Drainage System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical indications for placement of IPC for malignant pleural effusion
- Pleural effusion with symptomatic improvement in dyspnea after drainage of ipsilateral effusion
- Clinically confident symptomatic malignant pleural effusion confirmed by histocytological proof or recurrent large pleural effusion with known cancer
- Plans for placement of IPC within ten days of enrollment
- Age 18 years or older
- Sufficient fluid on ultrasound for safe IPC insertion
You will not qualify if you...
- Thoracic surgery or chest trauma causing chronic pain within the last 60 days
- 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 care for indwelling tunneled pleural catheter
- Significantly loculated pleural space precluding drainage by IPC
- Estimated life expectancy less than 30 days (hospice enrollment allowed)
- Inability to read, understand, or write English
- Inability to follow-up for appointments or protocol
- Any clinical or social condition contraindicating participation
- Enrollment in other pleural catheter trials that conflict with this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks
Participants undergo placement of an indwelling pleural catheter and are randomized to either vacuum-based or gravity-based drainage methods. They actively manage the catheter drainage as per their assigned strategy.
Visits at 2 weeks, 4 weeks, and 12 weeks post-placement, then as needed per standard clinical care
Duration - Variable duration following treatment completion
Participants complete quality of life questionnaires and update drainage diaries during follow-up visits to monitor outcomes and catheter management.
Follow-up visits as needed according to standard clinical protocol
Trial Site Locations
Total: 6 locations
1
Northwest Community Healthcare
Arlington Heights, Illinois, United States, 60005
Actively Recruiting
2
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Actively Recruiting
3
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
4
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
5
Swedish Medical Center
Seattle, Washington, United States, 98104
Actively Recruiting
6
University of Oxford
Oxford, United Kingdom
Not Yet Recruiting
Research Team
I
IP Research
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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