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NCT03831386 · ClinicalTrials.gov registry record · NA
Gravity Versus Vacuum Based Indwelling Tunneled Pleural Drainage System
A NA study of Pleural Effusion, sponsored by Johns Hopkins University.
- Recruiting
- Registry status
- NA
- Development phase
- 200
- Enrollment target
- 6
- Study locations
NCT03831386: Recruiting NA study of Pleural Effusion, sponsored by Johns Hopkins University.
NCT03831386 is a NA study of Pleural Effusion that is actively recruiting participants, run by Johns Hopkins University. The registered enrollment target is 200 participants, above the 163-participant average among 6 other Pleural Effusion trials with a reported enrollment target (23% higher). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03831386, a NA study of Pleural Effusion, is actively recruiting participants, sponsored by Johns Hopkins University.
- RECRUITING
- Registry status
- NA
- Development phase
- 200 participants
- Enrollment target
- 6
- Study locations
Study 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.
Primary Outcome
The primary endpoint is the difference between the mean daily change in pain score during IPC drainage via the vacuum bottle technique and IPC drainage via the gravity bag technique over two weeks after IPC placement. Pre-drainage and post-drainage pain scores will be recorded each day of IPC placement. Measurements are in millimeters along a 10 cm VAS. VAS score is a range of 0 to 100. Lower limit is 0, meaning no pain; upper limit is 100, meaning extreme pain.
Conditions Studied
Interventions
- PROCEDURE Vacuum-Based IPC
- PROCEDURE Gravity-Based IPC
Study Locations (6)
Illinois
- Northwest Community Healthcare - Arlington Heights
Maryland
- Johns Hopkins Hospital - Baltimore
South Carolina
- Medical University of South Carolina - Charleston
Tennessee
- Vanderbilt University Medical Center - Nashville
Washington
- Swedish Medical Center - Seattle
Other
- University of Oxford - Oxford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2019-01-31 |
| Est. Completion | 2026-12-31 |
| Phase | NA |
What NCT03831386 shows while recruiting
NCT03831386 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, above the 163-participant average among 6 other Pleural Effusion trials with a reported enrollment target (23% higher).
The record links to 1 condition, with Pleural Effusion appearing as the primary indexed condition, and to 2 interventions - of which Vacuum-Based IPC is the first listed.
NCT03831386 lists 6 locations in 6 states (Illinois, Maryland, South Carolina).
Frequently Asked Questions
What is clinical trial NCT03831386 about?
NCT03831386 is a clinical study titled "Gravity Versus Vacuum Based Indwelling Tunneled Pleural Drainage System". 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 tech...
What is the current status of trial NCT03831386?
This trial is currently recruiting. It is a NA study. The enrollment target is 200 participants. The study started on 2019-01-31. Estimated completion is 2026-12-31.
What conditions does trial NCT03831386 study?
This clinical trial studies the following conditions: Pleural Effusion.
What interventions are being tested in trial NCT03831386?
The interventions under investigation include: Vacuum-Based IPC (PROCEDURE), Gravity-Based IPC (PROCEDURE).
Who is sponsoring clinical trial NCT03831386?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03831386 being conducted?
This trial has 6 study locations across Illinois, Maryland, South Carolina, Tennessee, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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