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Gravity Versus Vacuum Based Indwelling Tunneled Pleural Drainage System (NEWTON)

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ClinicalTrials.gov Identifier: NCT03831386
Recruitment Status : Recruiting
First Posted : February 5, 2019
Last Update Posted : February 5, 2019
Sponsor:
Collaborators:
Rocket Medical plc
Swedish Medical Center
Medical University of South Carolina
University of Oxford
Vanderbilt University Medical Center
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Pleural Effusion Procedure: Vacuum-Based IPC Procedure: Gravity-Based IPC Not Applicable

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Impact of a Gravity Versus Vacuum Based Indwelling Tunneled Pleural Drainage System on Pain: A Multicenter, Randomized Trial
Actual Study Start Date : January 31, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Arm Intervention/treatment
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.
Procedure: Vacuum-Based IPC
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.

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.
Procedure: Gravity-Based IPC
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.




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


Secondary Outcome Measures :
  1. Change in mean difference in chest pain as assessed by VAS [ Time Frame: pre-IPC placement, 12 weeks post IPC placement or time of pleurodesis ]
    This secondary endpoint is the difference between the change in pain scores via vacuum bottle vs. gravity bag pre-IPC placement to the last available score after IPC placement. This last available score would be at 12 weeks or time of pleurodesis. Measurements are in millimeters along a 10 cm Visual Analog Scale (VAS). VAS score is a range of 0 to 100. Lower limit is 0, meaning no pain; upper limit is 100, meaning extreme pain.

  2. Change in SF 36-Item Health Survey score [ Time Frame: pre-IPC placement, 12 weeks post IPC placement or time of pleurodesis ]
    This secondary endpoint is the difference between SF 36-Item Health Survey 1.0 scores via vacuum bottle vs. gravity bag from pre-IPC drainage to last available score after IPC placement (at 12 weeks or time of pleurodesis). Scoring is a 2-step process in which the numerical response from the Survey is first converted into a 0-100 scale (0 as lowest and 100 as highest possible score) using a conversion table by SF developers. These new values would be averaged according to their group identified in a second conversion table.

  3. Change in Functional Assessment of Chronic Illness Therapy (FACIT)-Dyspnea survey score [ Time Frame: pre-IPC placement, 12 weeks post IPC placement or time of pleurodesis ]
    This secondary endpoint is the difference between FACIT-Dyspnea scores via vacuum bottle vs. gravity bag from pre-IPC drainage to the last available score after IPC placement (at 12 weeks or time of pleurodesis). Individual responses are converted into scores, then summed for an overall score. Scores range from 0 (lower limit) to 30 (high limit); the higher the score, the worse the dyspnea.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03831386


Contacts
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Contact: IP Research 410-502-2533 IPresearch@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Lonny Yarmus    410-502-5224    lyarmus@jhmi.edu   
Principal Investigator: Lonny Yarmus         
United States, South Carolina
Medical University of South Carolina Not yet recruiting
Charleston, South Carolina, United States, 29425
Contact: Nicholas J Pastis, MD    843-792-9200    pastisn@musc.edu   
United States, Tennessee
Vanderbilt University Medical Center Not yet recruiting
Nashville, Tennessee, United States, 37232
Contact: Fabien Maldonado, MD    615-936-8422    fabien.maldonado@vanderbilt.edu   
United States, Washington
Swedish Medical Center Not yet recruiting
Seattle, Washington, United States, 98104
Contact: Christopher R. Gilbert, MD    206-215-6800    Christopher.Gilbert@swedish.org   
United Kingdom
University of Oxford Not yet recruiting
Oxford, United Kingdom
Contact: Najib M Rahman, FRCP DPhil    01865 225205    najib.rahman@ndm.ox.ac.uk   
Sponsors and Collaborators
Johns Hopkins University
Rocket Medical plc
Swedish Medical Center
Medical University of South Carolina
University of Oxford
Vanderbilt University Medical Center
Investigators
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Principal Investigator: Lonny Yarmus, DO Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03831386     History of Changes
Other Study ID Numbers: IRB00158671
First Posted: February 5, 2019    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: De-identified individual study data will be used for analysis by lead PI and analyst. However, study is using REDCap database system with restrictions so that researchers only see individual data from their own site.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Pleural Effusion
Pleural Diseases
Respiratory Tract Diseases