Gravity Versus Vacuum Based Indwelling Tunneled Pleural Drainage System
Gravity Versus Vacuum Based Indwelling Tunneled Pleural Drainage System
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.
Lung
N/A
Adults
Not Available
Not Available
Maldonado, Fabien
National
Vanderbilt University
09-27-2018
Eligibility
18 Years and older
ALL
false
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
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
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
Plans for placement of IPC within ten days of enrollment
Age > 17 years
Age > 17 years
Sufficient fluid on ultrasound to allow for safe insertion of IPC
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
Recent (less than 60 days) thoracic surgery or chest trauma causing chronic pain
Pregnant or lactating mothers
Pregnant or lactating mothers
Previous ipsilateral chemical pleurodesis
Previous ipsilateral chemical pleurodesis
Current contralateral indwelling pleural catheter
Current contralateral indwelling pleural catheter
Known rib or thoracic skeletal metastasis causing pain
Known rib or thoracic skeletal metastasis causing pain
Concern for active pleural infection
Concern for active pleural infection
Respiratory failure
Respiratory failure
Irreversible bleeding diathesis
Irreversible bleeding diathesis
Inability to provide care for indwelling tunneled pleural catheter
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
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)
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 read/understand/write in the English language
Inability to follow-up for appointments/protocol
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.
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
Enrollment in alternative pleural catheter trial that would preclude enrollment within this trial
Clinical indications for placement of IPC for malignant pleural effusion a. Pleural effusion with symptomatic improvement in dyspnea after drainage of ipsilateral effusion
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
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
Plans for placement of IPC within ten days of enrollment
Age > 17 years
Age > 17 years
Sufficient fluid on ultrasound to allow for safe insertion of IPC
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
Recent (less than 60 days) thoracic surgery or chest trauma causing chronic pain
Pregnant or lactating mothers
Pregnant or lactating mothers
Previous ipsilateral chemical pleurodesis
Previous ipsilateral chemical pleurodesis
Current contralateral indwelling pleural catheter
Current contralateral indwelling pleural catheter
Known rib or thoracic skeletal metastasis causing pain
Known rib or thoracic skeletal metastasis causing pain
Concern for active pleural infection
Concern for active pleural infection
Respiratory failure
Respiratory failure
Irreversible bleeding diathesis
Irreversible bleeding diathesis
Inability to provide care for indwelling tunneled pleural catheter
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
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)
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 read/understand/write in the English language
Inability to follow-up for appointments/protocol
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.
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
Enrollment in alternative pleural catheter trial that would preclude enrollment within this trial
