Study protocol for a randomised controlled trial of invasive versus conservative management of primary spontaneous pneumothorax.
Current management of primary spontaneous pneumothorax (PSP) is variable, with little evidence from randomised controlled trials to guide treatment. Guidelines emphasise intervention in many patients, which involves chest drain insertion, hospital admission and occasionally surgery. However, there is evidence that conservative management may be effective and safe, and it may also reduce the risk of recurrence. Significant questions remain regarding the optimal initial approach to the management of PSP.



This multicentre, prospective, randomised, open label, parallel group, non-inferiority study will randomise 342 participants with a first large PSP to conservative or interventional management. To maintain allocation concealment, randomisation will be performed in real time by computer and stratified by study site. Conservative management will involve a period of observation prior to discharge, with intervention for worsening symptoms or physiological instability. Interventional treatment will involve insertion of a small bore drain. If drainage continues after 1 hour, the patient will be admitted. If drainage stops, the drain will be clamped for 4 hours. The patient will be discharged if the lung remains inflated. Otherwise, the patient will be admitted. The primary end point is the proportion of participants with complete lung re-expansion by 8 weeks. Secondary end points are as follows: days in hospital, persistent air leak, predefined complications and adverse events, time to resolution of symptoms, and pneumothorax recurrence during a follow-up period of at least 1 year. The study has 95% power to detect an absolute non-inferiority margin of 9%, assuming 99% successful expansion at 8 weeks in the invasive treatment arm. The primary analysis will be by intention to treat.



Local ethics approval has been obtained for all sites. Study findings will be disseminated by publication in a high-impact international journal and presentation at major international Emergency Medicine and Respiratory meetings.



ACTRN12611000184976; Pre-results.
Centre for Clinical Research in Emergency Medicine, Harry Perkins Institute of Medical Research, University of Western Australia, Perth, Western Australia, Australia Emergency Department, Royal Perth Hospital, Perth, Western Australia, Australia.
Simon G A
SG
Brown
Centre for Clinical Research in Emergency Medicine, Harry Perkins Institute of Medical Research, University of Western Australia, Perth, Western Australia, Australia Department of Respiratory Medicine, Royal Perth Hospital, Perth, Western Australia, Australia.
Emma L
EL
Ball
Medical Research Institute of New Zealand, Wellington, New Zealand Capital and Coast District Health Board, Wellington, New Zealand.
Kyle
K
Perrin
Centre for Clinical Research in Emergency Medicine, Harry Perkins Institute of Medical Research, University of Western Australia, Perth, Western Australia, Australia.
Catherine A
CA
Read
Emergency Department, St George Hospital, Kogarah, New South Wales, Australia Faculty of Medicine, St George Clinical School, University of New South Wales, Kensington, New South Wales, Australia.
Stephen E
SE
Asha
Medical Research Institute of New Zealand, Wellington, New Zealand Capital and Coast District Health Board, Wellington, New Zealand.
Richard
R
Beasley
Emergency Department, Monash Medical Centre, Clayton, Victoria, Australia Department of Medicine, School of Clinical Sciences at Monash Health, Clayton, Victoria, Australia.
Diana
D
Egerton-Warburton
Adult Emergency Department, Auckland District Health Board, Auckland, New Zealand.
Peter G
PG
Jones
Emergency Medicine, Gold Coast Health Service District, Southport, Queensland, Australia School of Medicine, Bond University, Gold Coast, Queensland, Australia School of Medicine, Griffith University, Gold Coast, Queensland, Australia.
Gerben
G
Keijzers
Emergency Medical and Children's Services, The Prince Charles Hospital, Chermside, Queensland, Australia University of Queensland, Brisbane, Queensland, Australia.
Frances B
FB
Kinnear
Department of Respiratory and Sleep Medicine, The Sutherland Hospital, Sydney, New South Wales, Australia Department of Respiratory Medicine, St George Hospital, Sydney, New South Wales, Australia.
Ben C H
BC
Kwan
Respiratory Medicine, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia Centre for Respiratory Health, School of Medicine & Pharmacology, University of Western Australia, Perth, Western Australia, Australia.
Y C Gary
YC
Lee
Department of Cardiothoracic Surgery, Monash Health, Clayton, Victoria, Australia Department of Surgery, School of Clinical Sciences at Monash Health, Monash University, Clayton, Victoria, Australia.
Julian A
JA
Smith
Respiratory Department, Royal Perth Hospital, Perth, Western Australia, Australia.
Quentin A
QA
Summers
Department of Respiratory Medicine, The Cairns Hospital, Cairns, Queensland, Australia.
Graham
G
Simpson
D000293:Adolescent; D000328:Adult; D001315:Australia; D015505:Chest Tubes / Q000009:adverse effects; D000072700:Conservative Treatment / Q000379:methods*; D004322:Drainage / Q000379:methods*; D004636:Emergency Service, Hospital; D005260:Female; D005500:Follow-Up Studies; D006760:Hospitalization / Q000706:statistics & numerical data*; D006801:Humans; D007902:Length of Stay; D008297:Male; D009520:New Zealand; D011030:Pneumothorax / Q000628:therapy*; D011183:Postoperative Complications / Q000209:etiology; D011446:Prospective Studies; D012008:Recurrence; D012107:Research Design; D016896:Treatment Outcome; D055815:Young Adult
ACCIDENT & EMERGENCY MEDICINE