Gravity Versus Vacuum Based Indwelling Tunneled Pleural Drainage System

Launched by JOHNS HOPKINS UNIVERSITY · Feb 4, 2019

Keywords

ClinConnect Summary

This clinical trial is studying two different methods of draining fluid from the lungs in patients with a condition called malignant pleural effusion, which often occurs in people with advanced cancer. The trial will compare gravity drainage and suction drainage to see which method improves patients' quality of life and reduces discomfort during the drainage process. Researchers hope to find out which technique is more effective for managing this condition.

To be eligible for the trial, participants need to be adults over the age of 17 who have been diagnosed with a malignant pleural effusion and have plans to have a special drainage tube called an indwelling tunneled pleural catheter (IPC) placed within 10 days of joining the study. Some patients may not qualify if they have certain medical conditions or recent surgeries. Those who participate will have regular follow-ups and will be monitored to see how well the drainage method works for them. Overall, this trial aims to improve the care and comfort of patients dealing with this challenging condition.

Gender

ALL

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
• • 1. Histocytological proof of pleural malignancy
• • 2. 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