Gravity Versus Vacuum Based Indwelling Tunneled Pleural Drainage System

Last updated: December 9, 2024
Sponsor: Johns Hopkins University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lung Disease

Pleural Effusion

Treatment

Vacuum-Based IPC

Gravity-Based IPC

Clinical Study ID

NCT03831386
IRB00158671
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Clinical indications for placement of IPC for malignant pleural effusion a. Pleural effusion with symptomatic improvement in dyspnea after drainage ofipsilateral effusion

  • Clinically confident symptomatic malignant pleural effusion

  1. Histocytological proof of pleural malignancy

  2. Recurrent large pleural effusion in context of histologically proven canceroutside 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

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, forwhich IPC alone will likely not offer symptomatic benefit

  • Estimated life expectancy of < 30 days (however, active enrollment in hospiceprogram 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 theopinion of the investigator would mean participation in the study would becontraindicated.

  • Enrollment in alternative pleural catheter trial that would preclude enrollmentwithin this trial

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Vacuum-Based IPC
Phase:
Study Start date:
January 31, 2019
Estimated Completion Date:
December 31, 2026

Study Description

Indwelling tunneled pleural catheters (IPCs) are used to alleviate pleural effusion as a first-line therapeutic (albeit palliative) intervention. Limited data currently exists on drainage techniques and the impact the techniques may have on quality of life. Current recommendations for IPC drainage range from daily drainage to once a week drainage, as well as only when needed for dyspnea. It has been theorized that active drainage of effusions may have an impact on the development of chest discomfort/pain, whereas passive regimens may allow for more gradual intrathoracic pleural changes and potentially offer a difference in drainage discomfort.

The objective of this investigation is to compare different drainage strategies of indwelling pleural catheters (IPCs) regarding patient quality of life and outcomes. Patients will undergo placement of a pleural catheter as per standard institutional protocol. Patients will be randomized on a 1:1 basis into the suction drainage (active) arm or the gravity drainage (passive) arm. Patients will receive follow-up at two weeks, four weeks, twelve weeks and then as needed post IPC placement per standard clinical protocol. All patients will be asked to fill out quality of life questionnaires and update drainage diary information with patient's providers.

Patients will undergo standard care treatment throughout the disease course and no different interventions regarding the pleural disease will be performed as a result of enrollment within this study. Study interventions/procedures will consist of questionnaires and patient self-reported documentation regarding patient's care and outcomes.

Connect with a study center

  • University of Oxford

    Oxford,
    United Kingdom

    Site Not Available

  • Northwest Community Healthcare

    Arlington Heights, Illinois 60005
    United States

    Active - Recruiting

  • Johns Hopkins Hospital

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • Swedish Medical Center

    Seattle, Washington 98104
    United States

    Active - Recruiting

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