Gravity Versus Vacuum Based Indwelling Tunneled Pleural Drainage System

Pleural Effusion Clinical Trial

— NEWTON  

Official title:

The Impact of a Gravity Versus Vacuum Based Indwelling Tunneled Pleural Drainage System on Pain: A Multicenter, Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03831386
• Other study ID #: IRB00158671
• Status: Recruiting
• Phase: N/A
• Start date: January 31, 2019
• Est. completion date: December 31, 2026

Study information

• Verified date: December 2023
• Source: Johns Hopkins University
• Contact: IP Research
• Phone: 410-502-2533
• Email: IPresearch[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pleural Effusion

Intervention

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.
• 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.

Locations

Country	Name	City	State
United Kingdom	University of Oxford	Oxford
United States	Northwest Community Healthcare	Arlington Heights	Illinois
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Swedish Medical Center	Seattle	Washington

Sponsors (7)

Lead Sponsor	Collaborator
Johns Hopkins University	Medical University of South Carolina, Northwest Community Healthcare, Rocket Medical plc, Swedish Medical Center, University of Oxford, Vanderbilt University Medical Center

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	pre-IPC placement, 12 weeks post IPC placement or time of pleurodesis
Secondary	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.	pre-IPC placement, 12 weeks post IPC placement or time of pleurodesis
Secondary	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.	pre-IPC placement, 12 weeks post IPC placement or time of pleurodesis