Gravity Versus Vacuum Based Indwelling Tunneled Pleural Drainage System

Part of paid clinical trials in Arlington Heights, Illinois.

Sponsor
Johns Hopkins University
Study ID
NCT03831386
Status
Recruiting
Apply to this trial

Conditions

  • Pleural Effusion

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vacuum-Based IPC — PROCEDURE
    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 — PROCEDURE
    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.

Study Details

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.

Key Dates

Start date
Jan 31, 2019
Status verified
Dec 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 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.
  • Experimental: 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.

Primary Outcome Measure

Change in chest pain as assessed by Visual Analog Scale (VAS) [ Time Frame: Daily, up to 2 weeks ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Northwest Community HealthcareArlington HeightsIllinois60005
Neeraj Desai, MD
[email protected]
Brittany Adams
[email protected]
Johns Hopkins HospitalBaltimoreMaryland21287
Lonny Yarmus
[email protected]
410-502-5224
Lonny Yarmus (PRINCIPAL_INVESTIGATOR)
Medical University of South CarolinaCharlestonSouth Carolina29425
Gerard Silvestri, MD
[email protected]
843-792-9200
Vanderbilt University Medical CenterNashvilleTennessee37232
Fabien Maldonado, MD
[email protected]
615-936-8422
Swedish Medical CenterSeattleWashington98104
Christopher R. Gilbert, MD
[email protected]
206-215-6800

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By research site
Northwest Community Healthcare· Arlington Heights, ILJohns Hopkins Hospital· Baltimore, MDMedical University of South Carolina· Charleston, SCVanderbilt University Medical Center· Nashville, TNSwedish Medical Center· Seattle, WA

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