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

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12

Jan

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e 1

3

July

- D

ec

13

Jan

- J

un

e 1

4

July

- D

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14

Jan

- J

un

e 1

5

July

- D

ec

15

Jan

- J

un

e 1

6

July

- D

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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