Gravity vs. Vacuum Drainage Systems for Pleural Effusion

(NEWTON Trial)

Recruiting at 5 trial locations

Overseen By IP Research

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Thoracic surgery, Pregnancy, Infection, Respiratory failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the best method for draining fluid from around the lungs in individuals with advanced cancer. Researchers are comparing two methods: a gravity-based Indwelling Tunneled Pleural Catheter (IPC) and a vacuum-based IPC. The objective is to identify which method enhances quality of life and reduces pain during the procedure. Suitable participants have cancer-related fluid buildup around their lungs that impairs breathing and plan to receive an IPC within ten days. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance comfort and quality of life for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these drainage techniques are safe for pleural effusion patients?

Research has shown that indwelling pleural catheters (IPCs) are generally safe for treating pleural effusions, a condition where fluid accumulates around the lungs. These catheters can operate with either gravity-based or vacuum-based drainage systems. Some patients may experience discomfort or chest pain during drainage. Although complications such as infection, air leaks, and valve problems can occur, they are uncommon.

Previous studies on vacuum-based IPCs, despite limited evidence, suggest they can alleviate symptoms without major safety concerns. Gravity-based IPCs have been studied less, but they function similarly and are considered similarly safe.

In summary, both treatments are regarded as safe but may cause some discomfort during use. Discuss any concerns with the medical team before joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring new drainage methods for pleural effusion because they offer potentially more effective and user-friendly options compared to traditional chest tube drainage systems. The gravity-based method uses simple gravity to move pleural fluid into a bedside bag, which might be less invasive and more comfortable for patients who can manage it themselves at home. The vacuum-based system, on the other hand, provides a controlled suction that can be tailored by the proceduralist, potentially offering a more efficient drainage process. These techniques could lead to more personalized and less burdensome management of pleural effusion.

What evidence suggests that these drainage techniques could be effective for pleural effusion?

Research has shown that indwelling pleural catheters (IPCs) effectively manage fluid build-up around the lungs caused by cancer, known as malignant pleural effusions. These catheters relieve symptoms like breathlessness by draining the fluid. In this trial, participants will join one of two treatment arms: the gravity-based IPC or the vacuum-based IPC. Studies indicate that both gravity-based and vacuum-based IPCs perform well for this purpose. The gravity-based system uses gravity to drain fluid into a bag, while the vacuum-based system employs a syringe and valve to create suction. Both methods aim to improve patients' quality of life by reducing discomfort and chest pain during drainage. ^{1 3 5 6 7}

Who Is on the Research Team?

Lonny Yarmus, DO

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for adults over 17 with malignant pleural effusion, who've felt better after draining fluid from the chest. They must be able to safely have a catheter inserted and manage its care. Excluded are those with certain conditions like bleeding disorders, recent chest surgeries or trauma, very short life expectancy, or current infections.

Inclusion Criteria

My cancer diagnosis was confirmed with a tissue sample.

I am scheduled to get an IPC placed within 10 days of joining.

I have fluid buildup in my chest that is cancer-related.

Exclusion Criteria

I am experiencing respiratory failure.

I can attend all required appointments.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo placement of a pleural catheter and are randomized into suction drainage (active) or gravity drainage (passive) arms

12 weeks

Follow-up at 2 weeks, 4 weeks, 12 weeks, and as needed

Follow-up

Participants are monitored for safety and effectiveness after treatment, including quality of life assessments and pain monitoring

12 weeks

Regular follow-up visits as per standard clinical protocol

What Are the Treatments Tested in This Trial?

Interventions

• Gravity-Based IPC
• Vacuum-Based IPC

Trial Overview The study compares two ways of draining fluid buildup in the chest due to cancer: using gravity or vacuum suction through an indwelling tunneled pleural catheter (IPC). It aims to see which method improves quality of life and has better outcomes.

How Is the Trial Designed?

Group I: Gravity Experimental Treatment 1 Intervention

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

Group II: Vacuum Active Control 1 Intervention

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.

Gravity-Based IPC is already approved in United States, European Union, Canada for the following indications:

Approved in United States as PleurX Catheter for:

• Malignant pleural effusion

Approved in European Union as Indwelling Tunneled Pleural Catheter (IPC) for:

• Malignant pleural effusion

Approved in Canada as PleurX Catheter for:

• Malignant pleural effusion

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Rocket Medical plc

Collaborator

Trials

5

Recruited

660+

Swedish Medical Center

Collaborator

Trials

55

Recruited

8,500+

Medical University of South Carolina

Collaborator

Trials

994

Recruited

7,408,000+

University of Oxford

Collaborator

Trials

1,113

Recruited

21,220,000+

Vanderbilt University Medical Center

Collaborator

Trials

922

Recruited

939,000+

Northwest Community Healthcare

Collaborator

Trials

2

Recruited

650+

Published Research Related to This Trial

Indwelling pleural catheters (IPCs) significantly reduce the initial length of hospital stay for patients with malignant pleural effusion compared to talc pleurodesis, but they also lead to a considerable number of outpatient follow-up visits, averaging 1.3 visits per patient.

Despite their benefits, IPCs are associated with a notable hospital visit burden, with 19% of non-MPE and 24% of MPE patients requiring additional reviews, indicating that healthcare services must be prepared for the increased workload associated with managing IPCs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Hospital and Patient Burden of Indwelling Pleural Catheters: A Retrospective Case Series of 210 Indwelling Pleural Catheter Insertions. Asciak, R., Hallifax, RJ., Mercer, RM., et al.[2022]

Tunneled indwelling pleural catheters (IPCs) are effective for relieving symptoms of dyspnea caused by recurrent pleural effusions, but their drainage valves can malfunction, leading to the need for catheter replacement.

The authors successfully repaired malfunctioning IPC drainage valves using a noninvasive method, highlighting the importance of developing a repair kit and standardized procedures to avoid the risks associated with catheter replacement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive Management of Fractured Indwelling Tunneled Pleural Catheter Valve. Shahid, A., Singh, H., Espina, TD., et al.[2022]

In a study involving 231 critically ill patients, using tunneled internal jugular catheters significantly reduced the risk of catheter-related sepsis and septicemia, with odds ratios of 0.33 and 0.23 respectively, indicating a strong protective effect.

The findings suggest that subcutaneous tunnelization of catheters can effectively lower the incidence of infections associated with internal jugular catheters, which is crucial for improving patient safety in intensive care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of subcutaneous tunneling on internal jugular catheter-related sepsis in critically ill patients: a prospective randomized multicenter study. Timsit, JF., Sebille, V., Farkas, JC., et al.[2016]

A new technique for placing tunneled dialysis catheters (TDCs) using a C-shaped micropuncture needle and real-time ultrasound guidance was successfully demonstrated.

In a study involving 12 TDC placements, the procedure was completed without complications and showed effective results over an average follow-up period of 2 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

De novo placement of a tunneled dialysis catheter over a wire with the single-incision technique. Contractor, SG., Phatak, TD., Bhagat, N.[2008]

The use of indwelling pleural catheters (IPC) for treating malignant pleural effusion (MPE) was effective and safe, with 87.7% of patients reporting improved breathing and a spontaneous pleurodesis rate of 34.4%.

While the overall treatment cost was lower for outpatients (€3310.2) compared to inpatients (€5450.3), complications from the procedure increased costs significantly in both groups, highlighting the importance of managing potential complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of malignant pleural effusion by an indwelling pleural catheter: A cost-efficiency analysis. Rial, MB., Lamela, IP., Fernández, VL., et al.[2022]

Indwelling pleural catheters (IPCs) are a safe option for managing recurrent pleural effusions, with complications occurring in less than 5% of patients, typically manageable with antibiotics.

While IPCs can lead to issues like pleural loculations in 10% of patients, these can often be treated effectively with intrapleural fibrinolytic therapy, highlighting the importance of ongoing management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of indwelling pleural catheter use and their management. Lui, MM., Thomas, R., Lee, YC.[2018]

The HeRO Vascular Access Device shows significantly lower rates of infectious complications compared to traditional tunneled dialysis catheters (TDC), making it a safer option for chronic hemodialysis.

With a successful placement rate of over 90% in catheter-dependent patients, the HeRO device offers a reliable alternative to TDC, with secondary patency rates comparable to prosthetic accesses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HeRO Vascular Access Device. Glickman, MH.[2011]

Indwelling pleural catheters (IPC) lead to shorter hospital stays and fewer repeat procedures compared to chemical pleurodesis in managing malignant pleural effusions, based on a meta-analysis of five trials with 545 patients.

However, IPC is associated with a significantly higher risk of cellulitis, indicating that while it may improve some patient-centered outcomes, safety concerns must be carefully considered.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indwelling Pleural Catheter versus Pleurodesis for Malignant Pleural Effusions. A Systematic Review and Meta-Analysis. Iyer, NP., Reddy, CB., Wahidi, MM., et al.[2020]

In a study of 47 patients with end-stage renal disease, femoral tunneled-cuffed catheters (TCC) with tips positioned at the inferior vena cava (IVC) showed significantly higher primary patency rates compared to those with tips at non-IVC locations over 12 months (50.0% vs 28.5%).

The study found that while TCCs at the IVC had better catheter dysfunction-free survival, the overall infection rates were similar between both groups, indicating that positioning at the IVC improves functionality without increasing infection risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes for femoral tunneled-cuffed hemodialysis catheters with different tip positions: A single-center retrospective study. Wu, S., Zhang, L., Wang, Q., et al.[2023]

Indwelling pleural catheters (IPCs) have a high pleurodesis rate of 74% for treating benign pleural effusions, with factors like a performance status score of ≤2 and medical thoracoscopy significantly increasing the likelihood of successful pleurodesis.

Certain conditions, such as secondary pleural infection and connective tissue disease, can lead to earlier removal of IPCs, while complications like liver and heart failure can delay removal, indicating the importance of patient factors in managing IPC therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Predictors of Successful and Earlier Removal of Indwelling Pleural Catheters in Benign Pleural Effusions. Li, P., Hosseini, S., Zhang, T., et al.[2020]

Indwelling pleural catheters (IPC) are effective for managing malignant pleural effusions, but they can lead to complications such as significant air leaks and subcutaneous emphysema, as seen in this case report.

The air leak was likely caused by visceral pleural disruption during vacuum drainage after IPC placement, highlighting the need for emergency and respiratory physicians to be aware of this risk and its management challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prolonged air leak after IPC insertion: An unusual complication. Bhatnagar, M., Slight, R., Prasad, AB., et al.[2020]

The study compared a novel silver nitrate-coated indwelling pleural catheter (SNCIPC) to a standard uncoated catheter in managing malignant pleural effusions, involving 114 patients across multiple hospitals.

While the SNCIPC group had a faster median time to pleurodesis (4 days vs. 11 days), it did not show improved overall pleurodesis efficacy compared to the standard catheter, suggesting that the SNCIPC may not be beneficial for broader use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Silver Nitrate-coated versus Standard Indwelling Pleural Catheter for Malignant Effusions: The SWIFT Randomized Trial. Shrager, JB., Bhatnagar, R., Kearney, CT., et al.[2022]

A study involving 104 patients found that the insertion of indwelling pleural catheters (IPC) is safe for patients undergoing chemotherapy, with no significant increase in pleural infections compared to those not receiving chemotherapy.

Patients receiving chemotherapy had a significantly lower six-month mortality rate compared to those not on chemotherapy, suggesting that IPC management during chemotherapy may be beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of indwelling pleural catheter use in patients undergoing chemotherapy: a five-year retrospective evaluation. Hak, CC., Sivakumar, P., Ahmed, L.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03831386

Gravity Versus Vacuum Based Indwelling Tunneled Pleural ... The objective of this investigation is to compare different drainage strategies of indwelling pleural catheters (IPCs) regarding patient quality of life and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12373602/

The Evolution of the Indwelling Pleural Catheter - PMC Indwelling pleural catheters (IPC) are as effective as talc pleurodesis at improving breathlessness. Patients with IPCs will spend less time in ...

3. withpower.com withpower.com/trial/phase-pleural-effusion-2019-327f1

Gravity vs. Vacuum Drainage Systems for Pleural Effusion Tunneled, indwelling pleural catheters (IPCs) have been shown to be effective in managing malignant pleural effusions, allowing for fluid drainage and potential ...

4. ctv.veeva.com ctv.veeva.com/study/gravity-versus-vacuum-based-indwelling-tunneled-pleural-drainage-system

Gravity Versus Vacuum Based Indwelling Tunneled Pleural ... The objective of this investigation is to compare different drainage strategies of indwelling pleural catheters (IPCs) regarding patient quality ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7011895/

Indwelling pleural catheters for non-malignant ... At the time of data cut-off (27 March 2018), 10 patients were still alive (18.5%), 43 had died (79.6%), one was lost to follow-up (1.9%).

6. vanderbilt.trialstoday.org vanderbilt.trialstoday.org/trial/NCT03831386

Gravity Versus Vacuum Based Indwelling Tunneled Pleural ... The investigators propose to evaluate gravity drainage and suction drainage on quality of life measures and outcomes. Condition. Pleural ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT03831386/gravity-versus-vacuum-based-indwelling-tunneled-pleural-drainage-system?page=22&country=United%20Kingdom&city=Headington%2525252C%25252520Oxford

Gravity Versus Vacuum Based Indwelling Tunneled Pleural ... Clinical indications for placement of IPC for malignant pleural effusion a. Pleural effusion with symptomatic improvement in dyspnea after ...