Gravity Versus Vacuum Based Indwelling Tunneled Pleural Drainage System

NCT03831386 | Recruiting

• 1 other identifier: IRB00158671
• Study Type: interventional
• Target: 200
• Locations: 2 countries
• Sites: 6

Brief 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.

Conditions

Pleural Effusion

Outcome Measures

Primary Outcomes (1)

• Change in chest pain as assessed by Visual Analog Scale (VAS)

  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.

  Daily, up to 2 weeks

Secondary Outcomes (3)

• Change in mean difference in chest pain as assessed by VAS

  pre-IPC placement, 12 weeks post IPC placement or time of pleurodesis

• Change in SF 36-Item Health Survey score

  pre-IPC placement, 12 weeks post IPC placement or time of pleurodesis

• Change in Functional Assessment of Chronic Illness Therapy (FACIT)-Dyspnea survey score

  pre-IPC placement, 12 weeks post IPC placement or time of pleurodesis

Study Arms (2)

Vacuum

ACTIVE COMPARATOR

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.

Procedure: Vacuum-Based IPC

Gravity

EXPERIMENTAL

The pleural fluid will be drained using gravity drainage to a bag positioned at bedside. Participants in this arm will undergo Gravity-Based IPC.

Procedure: Gravity-Based IPC

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.

Vacuum

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.

Gravity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Histocytological proof of pleural malignancy
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Rocket Medical plc: collaborator
• Swedish Medical Center: collaborator
• Medical University of South Carolina: collaborator
• University of Oxford: collaborator
• Vanderbilt University Medical Center: collaborator
• Northwest Community Healthcare: collaborator

Study Sites (6)

Northwest Community Healthcare

Arlington Heights, Illinois, 60005, United States

RECRUITING

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

Swedish Medical Center

Seattle, Washington, 98104, United States

RECRUITING

University of Oxford

Oxford, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Pleural Effusion

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Lonny Yarmus, DO

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

IP Research

CONTACT

410-502-2533; IPresearch@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2019
• First Posted: February 5, 2019
• Study Start: January 31, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (5); GB (1)