Assessing experience, safety, and outcomes of the Passio Pump Drainage System

Not Applicable

• Conditions: Malignant pleural effusion; Respiratory

• Registration Number: ISRCTN16390322
• Lead Sponsor: orth Bristol NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-28
• Last Update Posted: 5 August 2024
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Confirmed presence of recurrent, symptomatic malignant effusion requiring long-term, intermittent drainage with an indwelling pleural catheter
2. Participant normally lives within the catchment area of North Bristol NHS Trust and is unlikely to relocate within 1 month
3. Aged 18 years or over
4. Able to provide informed consent

Exclusion Criteria

1. Known or suspected pleural cavity infection or sepsis
2. Known or suspected uncorrected coagulopathy
3. Contraindication to indwelling pleural catheter insertion
4. Anticipated survival of less than 1 month
5. Patient is a prisoner or young offender in the custody of HM Prison Service or an offender supervised by the probation service in England or Wales

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Safety will be evaluated using the number and type of device related adverse events at 28 days post IPC insertion<br>2. Patient reported outcomes in terms of chest pain and breathlessness will be measured using the mean change in self-reported pain and breathlessness scores, measured pre- and post- each IPC drainage (3-5 x weekly)<br>

Secondary Outcome Measures

Name	Time	Method
The overall patient experience of study involvement and use of both devices will be evaluated in semi-structured interviews arranged at the participants’ convenience following their 28 day follow up.