SPIRIT trial - Version 1.0
Research type
Research Study
Full title
Studying Pleuroscopy in Routine Pleural Infection Treatment (SPIRIT) Trial
IRAS ID
219173
Contact name
Rahul Bhatnagar
Contact email
Sponsor organisation
North Bristol NHS Trust
Duration of Study in the UK
1 years, 3 months, 29 days
Research summary
A pleural effusion is a collection of fluid between the lung and the chest wall. It commonly occurs as a result of pneumonia and can cause significant breathlessness. In about 10% of cases, this fluid can itself go on to become infected, which increases the chances of someone becoming unwell enough to need surgery, or even dying. It is, therefore, vital that the fluid is drained away completely soon after someone is diagnosed with pleural infection. This is usually done by inserting a small chest tube between the ribs and allowing the fluid to drain out over time. This treatment typically requires many days in hospital but is generally low risk.
Medical thoracoscopy is a common technique used to diagnose and drain effusions, although it is not routinely used for pleural infection in the UK as it tends to be reserved for those who are suspected of having cancer. It involves inserting a small camera between the ribs into the fluid and can be done under local anaesthetic. The procedure is very safe but carries a slightly higher risk of complications than standard chest tube insertion. However, the main benefit of the procedure is that it can allow a patient to spend less time in hospital because the chest is drained completely all at once.
This study is designed to see if a group of UK hospitals are able to safely offer medical thoracoscopy to patients with pleural infection. It will recruit 30 patients from 5 UK hospitals over a year and will randomly allocate half of them to undergo thoracoscopy and half to the standard chest drain. Over 3 months of follow-up, we shall also examine how the treatment affects patients themselves, and whether it is effective at reducing patients’ time in hospital or their need for surgery.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
17/YH/0074
Date of REC Opinion
12 Apr 2017
REC opinion
Further Information Favourable Opinion