Gravity Versus Vacuum Based Indwelling Tunneled Pleural Drainage System (NEWTON)
Pleural Effusion
About this trial
This is an interventional treatment trial for Pleural Effusion
Eligibility Criteria
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
- 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
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
Sites / Locations
- Northwest Community HealthcareRecruiting
- Johns Hopkins HospitalRecruiting
- Medical University of South CarolinaRecruiting
- Vanderbilt University Medical CenterRecruiting
- Swedish Medical CenterRecruiting
- University of Oxford
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Vacuum
Gravity
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.
The pleural fluid will be drained using gravity drainage to a bag positioned at bedside. Participants in this arm will undergo Gravity-Based IPC.