Tunnelled catheters for palliative care outcomes: study protocol for a prospective, multicentre observational study...

Area of Science:

• Palliative Care Medicine
• Thoracic Surgery
• Medical Device Evaluation

Background:

• Managing pleural effusion and ascites is vital for palliative care patients' quality of life (QoL).
• Tunnelled catheters offer outpatient insertion, reducing hospitalization and increasing home time for patients with limited life expectancy.
• This study protocol details a prospective, multicentre trial to assess QoL and the utility of tunnelled catheters in home care.

Purpose of the Study:

• To gain insights into patient-reported palliative care outcomes using tunnelled catheters.
• To evaluate the clinical use, safety, and performance of tunnelled catheters and drainage kits in a home environment.
• To assess the impact of tunnelled catheters on the quality of life for patients with symptomatic effusions.

Main Methods:

• A multicentre prospective study involving 150 patients with pleural effusion or ascites across five specialized sites in Germany.
• Patients will be followed for at least 6 months post-implantation of a tunnelled catheter.
• Primary outcome measured by the Palliative Care Outcome Scale (POS) questionnaire, supplemented by evaluation of catheter implantation, drainage kit use, and complication monitoring.

Main Results:

• (Study is prospective, results are pending and will be detailed upon completion.)
• The study aims to provide data on the effectiveness of tunnelled catheters in improving patient QoL.
• Complication rates and device performance in the home setting will be analyzed.

Conclusions:

• Findings will enhance understanding of palliative care outcomes with tunnelled catheter use.
• The study will offer deeper insights into the safety and clinical application of tunnelled catheters for effusion management.