The Impact of a Gravity Versus Vacuum Based Indwelling Tunneled Pleural Drainage System on Pain: A Multicenter, Randomized Trial

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Illinois
Northwest Community Healthcare
RECRUITING
Arlington Heights
Maryland
Johns Hopkins Hospital
RECRUITING
Baltimore
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Washington
Swedish Medical Center
RECRUITING
Seattle
Other Locations
United Kingdom
University of Oxford
NOT_YET_RECRUITING
Oxford
Contact Information
Primary
IP Research
IPresearch@jhmi.edu
410-502-2533
Time Frame
Start Date: 2019-01-31
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 200
Treatments
Active_comparator: Vacuum
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.
Experimental: Gravity
The pleural fluid will be drained using gravity drainage to a bag positioned at bedside. Participants in this arm will undergo Gravity-Based IPC.
Related Therapeutic Areas
Sponsors
Collaborators: Medical University of South Carolina, Vanderbilt University Medical Center, Northwest Community Healthcare, Swedish Medical Center, Rocket Medical plc, University of Oxford
Leads: Johns Hopkins University

This content was sourced from clinicaltrials.gov