Primary Spontaneous Pneumothorax Study

1. Primary Spontaneous
Pneumothorax study
A randomised controlled trial of invasive vs
conservative treatment of primary
spontaneous pneumothorax
Chief Investigators: Prof Simon Brown
Dr Emma Ball
NZ PSP Coordinator: Dr Kyle Perrin (NZ)

2. Primary outcome
 Proportion of subjects with complete lung
re-expansion at 8 weeks
Recruitment target = 342

3. Secondary outcomes
 Hospital admission days
 Persistent air leak (chest drain/catheter in situ for
3/7 or greater)
 Pneumothorax recurrence in follow up
 Time to recovery; discharge from hospital &
resolution of symptoms & cessation of analgesia
 Complications
 Patient satisfaction

4. Exclusion criteria
 Prior PSP on same side
 Secondary pneumothorax, i.e. trauma or
underlying lung disease
 Haemothorax / Bilateral pneumothorax
 Clinical instability
 Age <14 or >50, Pregnancy
 Lack of post discharge support
 Air travel in next 12/52

5. Collins Method
A = ____ cm
B = ____ cm
C = ____ cm
A + B + C = ___ cm
A + B + C must be 6 cm
(32%) or greater for
inclusion.
Pneumothorax measurement

6. 8 16
32
59
110
158
183
237
0
50
100
150
200
250
300
350
400
Jan-June12
July-Dec12
Jan-June13
July-Dec13
Jan-June14
July-Dec14
Jan-June15
July-Dec15
Jan-June16
July-Dec16
PSP Recruitment (to 13.01.16)

7. VIC
Box Hill
Casey
Dandenong
Monash
NSW
St George
The Sutherland
Royal North Shore
Blacktown & Mt Druitt
John Hunter
NZ
Wellington
Middlemore
Auckland
Waikato
Christchurch
WA
Royal Perth (lead site)
Armadale
Bunbury
Busselton
SCGH
Swan Districts
QLD
Cairns
Gold Coast
Mater
Royal Brisbane &
Women’s
The Prince Charles
Townsville
Sites open to recruitment

8. Online Randomisation

9. Conservative Arm

10. Interventional Arm

11. Follow up
 24-72 hrs - clinical + questionnaire
 2/52 – CXR resolution + questionnaire
 4/52 – CXR resolution + questionnaire
 8/52 – CXR resolution + questionnaire + spirometry
 6/12 - phone call re recurrence
 1 - 5 years – annual phone call re recurrence
Phone call follow up where appointment not possible or
DNA

12. Outcomes & Significance
 Improve understanding of the disease,
optimal management & recurrence rate
 Global impact – potentially a major change
in current medical practice & guidelines