Health TrialsbyHealthPanel

Gravity Versus Vacuum Based Indwelling Tunneled Pleural Drainage System

ConditionPleural Effusion
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohns Hopkins University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Clinical indications for placement of IPC for malignant pleural 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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vacuum-Based IPC

    Procedure/Surgery

    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

    Procedure/Surgery

    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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: VacuumActive comparator 1 intervention
Group B: GravityExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Daily, up to 2 weeks

Secondary outcomes

1

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.

Time frame
pre-IPC placement, 12 weeks post IPC placement or time of pleurodesis
2

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.

Time frame
pre-IPC placement, 12 weeks post IPC placement or time of pleurodesis
3

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.

Time frame
pre-IPC placement, 12 weeks post IPC placement or time of pleurodesis

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johns Hopkins University

Lead sponsor

Rocket Medical plc

Collaborator

Swedish Medical Center

Collaborator

Medical University of South Carolina

Collaborator

University of Oxford

Collaborator

Vanderbilt University Medical Center

Collaborator

Northwest Community Healthcare

Collaborator

Source ClinicalTrials.gov
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