200 Participants Needed

Gravity vs. Vacuum Drainage Systems for Pleural Effusion

(NEWTON Trial)

Recruiting at 5 trial locations
IR
Overseen ByIP Research
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Johns Hopkins University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the treatment Gravity-Based IPC, Indwelling Tunneled Pleural Catheter (IPC), PleurX Catheter, Vacuum-Based IPC, Indwelling Tunneled Pleural Catheter (IPC), PleurX Catheter 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 pleurodesis (a procedure to stick the lung to the chest wall to prevent fluid buildup). Although the study on silver nitrate-coated IPCs did not show improved effectiveness over standard IPCs, standard IPCs are still considered effective for managing pleural effusions.12345

Is the use of indwelling pleural catheters (IPCs) generally safe for humans?

Indwelling pleural catheters (IPCs) are generally considered safe for managing pleural effusions, though complications like infection, air leaks, and valve malfunctions can occur. These complications are usually manageable, and IPCs are often preferred over other treatments like talc pleurodesis due to their safety profile.678910

How is the treatment with Gravity-Based IPC and Vacuum-Based IPC different from other treatments for pleural effusion?

The Gravity-Based IPC and Vacuum-Based IPC treatments use indwelling pleural catheters (IPCs) to drain fluid from the chest, offering a less invasive option compared to traditional methods like chemical pleurodesis, which involves using chemicals to stick the lung to the chest wall. IPCs can be managed at home, reducing hospital stays and allowing patients more comfort and flexibility.67111213

What is the purpose of 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.

Research Team

Dr. Lonny Yarmus, DO - Baltimore, MD ...

Lonny Yarmus, DO

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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.
See 5 more

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.
See 12 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: GravityExperimental Treatment1 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: VacuumActive Control1 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

Find a Clinic Near You

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+

Findings from Research

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

References

Silver Nitrate-coated versus Standard Indwelling Pleural Catheter for Malignant Effusions: The SWIFT Randomized Trial. [2022]
Clinical outcomes for femoral tunneled-cuffed hemodialysis catheters with different tip positions: A single-center retrospective study. [2023]
Effect of subcutaneous tunneling on internal jugular catheter-related sepsis in critically ill patients: a prospective randomized multicenter study. [2016]
HeRO Vascular Access Device. [2011]
De novo placement of a tunneled dialysis catheter over a wire with the single-incision technique. [2008]
Noninvasive Management of Fractured Indwelling Tunneled Pleural Catheter Valve. [2022]
Management of malignant pleural effusion by an indwelling pleural catheter: A cost-efficiency analysis. [2022]
Complications of indwelling pleural catheter use and their management. [2018]
Prolonged air leak after IPC insertion: An unusual complication. [2020]
Safety of indwelling pleural catheter use in patients undergoing chemotherapy: a five-year retrospective evaluation. [2018]
11.United Statespubmed.ncbi.nlm.nih.gov
Indwelling Pleural Catheter versus Pleurodesis for Malignant Pleural Effusions. A Systematic Review and Meta-Analysis. [2020]
The Hospital and Patient Burden of Indwelling Pleural Catheters: A Retrospective Case Series of 210 Indwelling Pleural Catheter Insertions. [2022]
Clinical Predictors of Successful and Earlier Removal of Indwelling Pleural Catheters in Benign Pleural Effusions. [2020]
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