AESOP v1
Research type
Research Study
Full title
Assessing Experience, Safety and Outcomes of the Passio Pump Drainage System - a randomised controlled, crossover, exploratory study (AESOP)
IRAS ID
322486
Contact name
Nick Maskell
Contact email
Sponsor organisation
Research and Innovation
Duration of Study in the UK
1 years, 0 months, 28 days
Research summary
The pleural membranes are two thin layers of tissue covering the outside of the lung. Excess fluid can accumulate between these layers (a pleural effusion) causing breathlessness. This fluid can be managed with a semi-permanent catheter called an indwelling pleural catheter (IPC). These IPCs are drained regularly at home to manage the patient's symptoms and prevent effusion recurrence.
If the effusion is drained regularly, the pleura can adhere together, preventing further fluid accumulation (autopleurodesis). Evidence suggests that more frequent drainage promotes more rapid pleurodesis and earlier IPC removal. Unfortunately, due to shortages of community nurses, patients are often drained 3 times weekly, rather than 5 times weekly, as is best practice.
Current drainage systems use vacuum drainage bottles, which require considerable dexterity to use. This prohibits patients from managing their own drainages and increases the burden on community nurses, reducing patients’ drainage frequency. It can be challenging to control drainage rates with bottles, which can be uncomfortable.
The Passio Pump Drainage System uses a handheld electronic pump to drain fluid from an IPC into a bag, offering electronic control of drainage. It is more portable and simpler to use, which could allow patients to manage their own drainages more frequently.
AESOP is a randomised-controlled, crossover, exploratory study to gather information regarding the safety, tolerability and patient experience of the Passio Pump Drainage system compared to the BD PleurX drainage system. Eligible patients will be randomly allocated to have inserted either a Passio catheter or a BD PleurX IPC (current standard IPC) with a 3-5 x weekly drainage regimen. They will keep a symptom and drainage diary, with review at 2- and 4-weeks to assess whether their effusion has dried up and the catheter can be removed. This study has the potential to inform further research using this drainage system.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
24/NW/0020
Date of REC Opinion
14 Feb 2024
REC opinion
Further Information Favourable Opinion