A Randomised Controlled Trial for Primary Spontaneous Pneumothorax
Research type
Research Study
Full title
A Randomised Controlled Trial of Primary Spontaneous Pneumothorax - Conservative Management versus Aspiration for Small Pneumothoraces, Aspiration versus Intercostal Chest Drain Insertion for Large Pneumothoraces
IRAS ID
102280
Contact name
Stefan Marciniak
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust & the University of Cambridge
Research summary
The objective of the study is to improve the evidence-base for the treatment of primary spontaneous pneumothorax (PSP). The British Thoracic Society (BTS) guidelines are based predominantly on non-analytical studies and expert opinion. The American College of Chest Physicians (ACCP) produced a consensus statement guided only by expert opinion. In both documents, the size of the presenting PSP is used to determine initial treatment. However, no consensus regarding the definition of PSP severity exists, with the ACCP and BTS each using different arbitrary measurements of the presentation chest X-ray. When these were compared directly they showed poor correlation.
Currently, we are performing a prospective service evaluation of all PSP cases in the East of England, comparing the ability of the BTS definition of a large pneumothorax (>2cm at the hilum) and ACCP definition (>3cm apex to cupola) to predict the eventual need for intercostal chest insertion. This study does not need ethical approval since it involves evaluation of service provision.
Once we establish which definition is superior to predict a large pneumothorax, we will embark to this multi-centre prospective randomised controlled trial comparing conservative treatment versus aspiration for small pneumothoraces, and aspiration versus drain insertion for large pneumothoraces. Keeping a database of all cases in the region will be invaluable for the future. It is predicted that at least 10% of PSP cases have a genetic basis. The database could be used to find new genetic abnormalities in collaboration with the Sanger Institute.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
13/EE/0093
Date of REC Opinion
14 Aug 2013
REC opinion
Further Information Favourable Opinion