Malignant pleural effusion Respiratory
Conditions
Interventions
Participants will be randomised to IPC insertion with either a Bearpac Passio catheter or a standard catheter (BD PleurX). After 2 weeks, they will cross over to the alternative drainage system for a
Sponsors
North Bristol NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Safety will be evaluated using the number and type of device related adverse events at 28 days post IPC insertion 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) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
England, United Kingdom
Contacts
Public ContactEmma Tucker
Outcome results
None listed