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

Primary Purpose

Pleural Effusion

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Vacuum-Based IPC
Gravity-Based IPC
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pleural Effusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwest Community HealthcareRecruiting
  • Johns Hopkins HospitalRecruiting
  • Medical University of South CarolinaRecruiting
  • Vanderbilt University Medical CenterRecruiting
  • Swedish Medical CenterRecruiting
  • University of Oxford

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Vacuum

Gravity

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
February 4, 2019
Last Updated
December 6, 2022
Sponsor
Johns Hopkins University
Collaborators
Rocket Medical plc, Swedish Medical Center, Medical University of South Carolina, University of Oxford, Vanderbilt University Medical Center, Northwest Community Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT03831386
Brief Title
Gravity Versus Vacuum Based Indwelling Tunneled Pleural Drainage System
Acronym
NEWTON
Official Title
The Impact of a Gravity Versus Vacuum Based Indwelling Tunneled Pleural Drainage System on Pain: A Multicenter, Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Rocket Medical plc, Swedish Medical Center, Medical University of South Carolina, University of Oxford, Vanderbilt University Medical Center, Northwest Community Healthcare

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pleural Effusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vacuum
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Gravity
Arm Type
Experimental
Arm Description
The pleural fluid will be drained using gravity drainage to a bag positioned at bedside. Participants in this arm will undergo Gravity-Based IPC.
Intervention Type
Procedure
Intervention Name(s)
Vacuum-Based IPC
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Gravity-Based IPC
Intervention Description
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 Measure Information:
Title
Change in chest pain as assessed by Visual Analog Scale (VAS)
Description
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.
Time Frame
Daily, up to 2 weeks
Secondary Outcome Measure Information:
Title
Change in mean difference in chest pain as assessed by VAS
Description
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.
Time Frame
pre-IPC placement, 12 weeks post IPC placement or time of pleurodesis
Title
Change in SF 36-Item Health Survey score
Description
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.
Time Frame
pre-IPC placement, 12 weeks post IPC placement or time of pleurodesis
Title
Change in Functional Assessment of Chronic Illness Therapy (FACIT)-Dyspnea survey score
Description
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.
Time Frame
pre-IPC placement, 12 weeks post IPC placement or time of pleurodesis

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
IP Research
Phone
410-502-2533
Email
IPresearch@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lonny Yarmus, DO
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwest Community Healthcare
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neeraj Desai, MD
Email
desai@chestcenter.com
First Name & Middle Initial & Last Name & Degree
Brittany Adams
Email
badams1@NCH.ORG
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lonny Yarmus
Phone
410-502-5224
Email
lyarmus@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Lonny Yarmus
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerard Silvestri, MD
Phone
843-792-9200
Email
silvestr@musc.edu
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabien Maldonado, MD
Phone
615-936-8422
Email
fabien.maldonado@vanderbilt.edu
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher R. Gilbert, MD
Phone
206-215-6800
Email
Christopher.Gilbert@swedish.org
Facility Name
University of Oxford
City
Oxford
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Najib M Rahman, FRCP DPhil
Phone
01865 225205
Email
najib.rahman@ndm.ox.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

Gravity Versus Vacuum Based Indwelling Tunneled Pleural Drainage System

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