Management of Malignant Pleural Effusions Using an Indwelling Tunneled Pleural Catheter and Non-Vacuum Collection System

Completed

Brief Summary: In this study, the investigators will collect data on patients who are using the Aspira system as part of their clinical care for the management of recurrent pleural effusion. Data will be collected on patient demographics, placement of the pleural catheter, palliation of dyspnea, complication rates, and rates of spontaneous pleurodesis.

Recruitment & Eligibility

Inclusion Criteria

Male or female, at least 18 years of age, inclusive
Subject has a symptomatic malignant pleural effusion requiring intervention. For an effusion to be defined as malignant, at least one of the following must be true
- There is cytological confirmation of pleural malignancy
- The effusion is an exudate (per Light's criteria Pleural fluid protein/Serum protein >0.5, Pleural fluid LDH/Serum LDH >0.6, or Pleural fluid LDH >2/3 the upper limit of normal) in the context of histocytologically proven malignancy elsewhere, with no other clear cause for fluid identified
Subject is able to provide informed consent
Subject has sufficient pleural fluid to allow safe insertion of an indwelling tunneled pleural catheter as determined by the PI
Subject is able to perform home drainage of the pleural effusion or has sufficient resources (family member, caregiver, home health).

Exclusion Criteria

Subject is pregnant
Subject has evidence, in the opinion of the PI, of either ongoing systemic or pleural infection
Subjects with uncorrected coagulopathy

Arm && Interventions

Group	Intervention	Description
Aspira Catheter & Drainage System	Aspira Catheter	* Participants will have standard of care ultrasound and placement of the Aspira Catheter and Drainage System on Day 1 * The removal of the Aspira Catheter and Drainage System will be dependent upon future ultrasound assessment and fluid output
Aspira Catheter & Drainage System	Ultrasound	* Participants will have standard of care ultrasound and placement of the Aspira Catheter and Drainage System on Day 1 * The removal of the Aspira Catheter and Drainage System will be dependent upon future ultrasound assessment and fluid output

Primary Outcome Measures

Name	Time	Method
Relief of dyspnea as measured using the Visual Analog Scale for Dyspnea (VAS-Dyspnea)	Through 2 weeks following catheter insertion	* This will be determined based on the difference between the VAS-Dyspnea score on the day of catheter insertion prior to catheter insertion compared with the VAS-Dyspnea score on the 2 week follow up visit * The scale presents the question "how much shortness of breath are you having right now?" with a straight line. At one end it states "no shortness of breath" and the other end is "shortness of breath as bad as can be". The participant will mark the line on how they feel * No shortness is breath is 0% score and shortness of breath as bad as can be is 100% score

Secondary Outcome Measures

Name	Time	Method
Rate of spontaneous pleurodesis	1 year	-Defined as pleural fluid drainage less than 75ml every other day for three consecutive drainage sessions
Rate of infection	1 year	-Defined as the isolation of any bacteria within a pleural fluid specimen drawn for clinical purposes

Locations (1): Washington University School of Medicine
🇺🇸
Saint Louis, Missouri, United States

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