Comparing gravity and suction drainage for pleural effusion treatment
The Impact of a Gravity Versus Vacuum Based Indwelling Tunneled Pleural Drainage System on Pain: A Multicenter, Randomized Trial
This study is testing whether using gravity or suction to drain fluid from the lungs helps people with malignant pleural effusion feel more comfortable and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 6 sites (Arlington Heights, Illinois and 5 other locations) |
| Trial ID | NCT03831386 on ClinicalTrials.gov |
What this trial studies
This investigation aims to evaluate the effectiveness of two different drainage techniques—gravity drainage and suction drainage—using indwelling tunneled pleural catheters (IPCs) for patients with malignant pleural effusion. Patients will be randomly assigned to one of the two drainage methods and will undergo follow-up assessments at multiple intervals to measure quality of life and clinical outcomes. The study seeks to determine if the method of drainage impacts patient comfort and overall quality of life during treatment. Participants will complete quality of life questionnaires and maintain a drainage diary to provide comprehensive data on their experiences.
Who should consider this trial
Good fit: Ideal candidates include adults over 17 years old with symptomatic malignant pleural effusion requiring an indwelling pleural catheter.
Not a fit: Patients with recent thoracic surgery, active pleural infection, or other significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved quality of life for patients suffering from malignant pleural effusion by identifying the most effective drainage technique.
How similar studies have performed: While there is limited data on the comparison of drainage techniques for IPCs, this study addresses a gap in current knowledge and may provide novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Arlington Heights, Illinois and 5 other locations
- Northwest Community Healthcare — Arlington Heights, Illinois, United States (Recruiting)
- Johns Hopkins Hospital — Baltimore, Maryland, United States (Recruiting)
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
- Swedish Medical Center — Seattle, Washington, United States (Recruiting)
- University of Oxford — Oxford, United Kingdom (Not_yet_recruiting)
Study contacts
- Principal investigator: Lonny Yarmus, DO — Johns Hopkins University
- Study coordinator: IP Research
- Email: IPresearch@jhmi.edu
- Phone: 410-502-2533
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.