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)
Primary outcome
Proportion of subjects with complete lung re-expansion at 8 weeks
Recruitment target = 342
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
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
Collins MethodA = ____ cm
B = ____ cm
C = ____ cm
A + B + C = ___ cm
A + B + C must be 6 cm (32%) or greater for inclusion.
Pneumothorax measurement
8 1632
59
110
158183
237
0
50
100
150
200
250
300
350
400Ja
n -
Ju
ne
12
July
- D
ec
12
Jan
- J
un
e 1
3
July
- D
ec
13
Jan
- J
un
e 1
4
July
- D
ec
14
Jan
- J
un
e 1
5
July
- D
ec
15
Jan
- J
un
e 1
6
July
- D
ec
16
PSP Recruitment (to 13.01.16)
VICBox HillCaseyDandenongMonash
NSWSt GeorgeThe SutherlandRoyal North Shore Blacktown & Mt DruittJohn Hunter
NZWellingtonMiddlemoreAucklandWaikatoChristchurch
WARoyal Perth (lead site)ArmadaleBunburyBusseltonSCGHSwan Districts
QLDCairnsGold CoastMaterRoyal Brisbane & Women’sThe Prince CharlesTownsville
Sites open to recruitment
Online Randomisation
Conservative Arm
Interventional Arm
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
Outcomes & Significance
Improve understanding of the disease, optimal management & recurrence rate
Global impact – potentially a major change in current medical practice & guidelines
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