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
|Condition or disease||Intervention/treatment||Phase|
|Pleural Effusion||Procedure: Vacuum-Based IPC Procedure: Gravity-Based IPC||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
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.
- 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.
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03831386
|Contact: IP Research||410-502-2533||IPresearch@jhmi.edu|
|United States, Maryland|
|Johns Hopkins Hospital||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Lonny Yarmus 410-502-5224 firstname.lastname@example.org|
|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 email@example.com|
|United States, Tennessee|
|Vanderbilt University Medical Center||Not yet recruiting|
|Nashville, Tennessee, United States, 37232|
|Contact: Fabien Maldonado, MD 615-936-8422 firstname.lastname@example.org|
|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|
|University of Oxford||Not yet recruiting|
|Oxford, United Kingdom|
|Contact: Najib M Rahman, FRCP DPhil 01865 225205 email@example.com|
|Principal Investigator:||Lonny Yarmus, DO||Johns Hopkins University|