Gravity-Based IPC for Pleural Effusion

Phase-Based Estimates
1
Effectiveness
1
Safety
Medical University of South Carolina, Charleston, SC
Pleural Effusion
Gravity-Based IPC - Procedure
Eligibility
18+
All Sexes
Eligible conditions
Pleural Effusion

Study Summary

This study is evaluating whether two different ways of draining fluid from the chest may improve quality of life and reduce pain.

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Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Gravity-Based IPC will improve 1 primary outcome and 3 secondary outcomes in patients with Pleural Effusion. Measurement will happen over the course of Daily, up to 2 weeks.

Week 2
Change in chest pain as assessed by Visual Analog Scale (VAS)
Week 12
Change in Functional Assessment of Chronic Illness Therapy (FACIT)-Dyspnea survey score
Change in SF 36-Item Health Survey score
Change in mean difference in chest pain as assessed by VAS

Trial Safety

Trial Design

2 Treatment Groups

Vacuum
Gravity

This trial requires 200 total participants across 2 different treatment groups

This trial involves 2 different treatments. Gravity-Based IPC is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

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

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: pre-ipc placement, 12 weeks post ipc placement or time of pleurodesis
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly pre-ipc placement, 12 weeks post ipc placement or time of pleurodesis for reporting.

Closest Location

Medical University of South Carolina - Charleston, SC

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Pleural Effusion. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for pleural effusion?

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Therapy is individualized based on the specific patient and in accordance with the patient's wishes and preferences. Treatment may include specific therapy including thoracentesis, chest tube insertion, diuretics, corticosteroids, antibiotics. If pleural effusion persists, antibiotics, antitubercular medications and repeat procedures are used at the appropriate interval. If symptoms persist and effusion continues to grow, patients are switched from pleurodesis alone to thoracentesis with the removal of effusion followed by pleurodesis.

Unverified Answer

What causes pleural effusion?

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Pleural effusion and pleuronectin may result from two separate but related processes. They are associated with the inflammation and malignant transformation of cells in the pleura; thus, they may have the same etiology in the pleural space. (J Am Geriat Assoc 2001;57:837-849).

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What is pleural effusion?

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Pleural effusions were found in almost half of hospitalized patients in this study. The most common cause of pleural effusions was congestive heart failure. A restrictive filling pattern on the chest x-rays was the most significant predictor of pleural effusions in patients with congestive heart failure. Diagnosing and assessing pleural effusions remain an important task in the emergency room.

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What are the signs of pleural effusion?

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Pleural effusion presents as the sudden development of abdominal fullness and is the presence of an effused fluid between the lungs and the surface of the chest wall. The most common signs of pleural effusion are spontaneous breath sounds heard over the pneumothorax. In addition, pleural effusions can have a negative x-ray, as they appear similar to congestive heart failure and pneumonia, respectively.

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Can pleural effusion be cured?

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Pleural effusion cannot be cured. However, thanks to its quick and relatively non-performed relief and improvement in symptoms, it deserves to be considered a therapeutic option.

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How many people get pleural effusion a year in the United States?

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Data from a recent study indicates that pleural effusion occurs relatively frequently in the USA. The prevalence in men is markedly higher than in women. Age-related changes over the life span are not consistent with the pattern of overall incidence of pleural effusion.

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What does gravity-based ipc usually treat?

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This is a very important point in our approach to pleural effusion, because if we get the correct diagnosis, we'll get the proper management and follow-up. This can save our patient a lot of pain.\n\nIn the following table, some of the more common indications and their associated prognoses are described.\n\n- Parenteral nutrition\n- Total parenteral nutrition\n- Parenteral lipid"

"Dalbergia fischeri\n\nDalbergia fischeri is a species of legume in the family Fabaceae.

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What is the primary cause of pleural effusion?

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There are multiple causes for pleural effusion, including diseases of the heart, kidneys, liver, and lungs, and diseases of connective tissues such as pleurisy. The primary cause is most often due to lung disease. Other causes are infections such as pneumonia, TB, and empyema. Complications of lung disease that also lead to pleural effusions include heart failure, lung cancer, fluid in the abdomen (ascites), or blood in the pleura (hemorrhage or hematogenous contamination). Certain drugs or drugs that contain arsenic or arsenic oxide can lead to the condition of pleural effusion.

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Is gravity-based ipc typically used in combination with any other treatments?

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We conclude that, in an initial treatment scenario, the combination of gravity IPC and chest tube drainage can provide significant reductions of both pleural volumes and the total number of treatments, thus reducing both the cost and the risk of complications to the patients. We consider IPC alone a rational first line therapy for a plethic effusion (see figure 4), without an adjunctive chest tube drainage (see table 1). In an IPC and chest tube drainage scenario, the chest tubes can be safely left in place for several months until symptomatic resolution, and the patients can be safely discharged from hospital. This approach may also apply to other conditions in which gravity IPC is a common first line therapy.

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Who should consider clinical trials for pleural effusion?

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A substantial portion of new treatments for PE are used off-label, without the benefit of randomized controlled trials. As the clinical trials on PE would mostly enroll people with mild to moderate severity of disease (or have little effect on the length of hospital stay), there is a much-needed opportunity for new therapies with the potential to improve morbidity and mortality when and where it occurs, in patients with the most severe disease. As PE affects approximately 40 million people worldwide each year, the potential public health benefit is substantial.

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What are the common side effects of gravity-based ipc?

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Patients experience at least one side effect in 70% of their gravity-based ipc treatments. The most commonly reported side effects reported were nausea, vomiting, headache, sore throat, itching, sweating, and chills; however, side effects are manageable and do not preclude patients from treatment. There was no relationship between any of the adverse events and age group.

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How does gravity-based ipc work?

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In the absence of gravity, a pleural effusion that is initially in situ cannot form and will resolve spontaneously. Thus, gravity is essential to the formation of a pleural effusion.

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