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Respiratory medicine
Protocol
Study protocol for a randomised controlled trial of invasive versus conservative management of primary spontaneous pneumothorax
  1. Simon G A Brown1,2,
  2. Emma L Ball1,3,
  3. Kyle Perrin4,5,
  4. Catherine A Read1,
  5. Stephen E Asha6,7,
  6. Richard Beasley4,5,
  7. Diana Egerton-Warburton8,9,
  8. Peter G Jones10,
  9. Gerben Keijzers11,12,13,
  10. Frances B Kinnear14,15,
  11. Ben C H Kwan16,17,
  12. Y C Gary Lee18,19,
  13. Julian A Smith20,21,
  14. Quentin A Summers22,
  15. Graham Simpson23,
  16. the PSP Study Group
  1. 1Centre for Clinical Research in Emergency Medicine, Harry Perkins Institute of Medical Research, University of Western Australia, Perth, Western Australia, Australia
  2. 2Emergency Department, Royal Perth Hospital, Perth, Western Australia, Australia
  3. 3Department of Respiratory Medicine, Royal Perth Hospital, Perth, Western Australia, Australia
  4. 4Medical Research Institute of New Zealand, Wellington, New Zealand
  5. 5Capital and Coast District Health Board, Wellington, New Zealand
  6. 6Emergency Department, St George Hospital, Kogarah, New South Wales, Australia
  7. 7Faculty of Medicine, St George Clinical School, University of New South Wales, Kensington, New South Wales, Australia
  8. 8Emergency Department, Monash Medical Centre, Clayton, Victoria, Australia
  9. 9Department of Medicine, School of Clinical Sciences at Monash Health, Clayton, Victoria, Australia
  10. 10Adult Emergency Department, Auckland District Health Board, Auckland, New Zealand
  11. 11Emergency Medicine, Gold Coast Health Service District, Southport, Queensland, Australia
  12. 12School of Medicine, Bond University, Gold Coast, Queensland, Australia
  13. 13School of Medicine, Griffith University, Gold Coast, Queensland, Australia
  14. 14Emergency Medical and Children's Services, The Prince Charles Hospital, Chermside, Queensland, Australia
  15. 15University of Queensland, Brisbane, Queensland, Australia
  16. 16Department of Respiratory and Sleep Medicine, The Sutherland Hospital, Sydney, New South Wales, Australia
  17. 17Department of Respiratory Medicine, St George Hospital, Sydney, New South Wales, Australia
  18. 18Respiratory Medicine, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia
  19. 19Centre for Respiratory Health, School of Medicine & Pharmacology, University of Western Australia, Perth, Western Australia, Australia
  20. 20Department of Cardiothoracic Surgery, Monash Health, Clayton, Victoria, Australia
  21. 21Department of Surgery, School of Clinical Sciences at Monash Health, Monash University, Clayton, Victoria, Australia
  22. 22Respiratory Department, Royal Perth Hospital, Perth, Western Australia, Australia
  23. 23Department of Respiratory Medicine, The Cairns Hospital, Cairns, Queensland, Australia
  1. Correspondence to Dr Kyle Perrin; kyle.perrin{at}ccdhb.org.nz

Abstract

Introduction 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.

Methods and analysis 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.

Ethics and dissemination 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.

Trial registration number ACTRN12611000184976; Pre-results.

  • ACCIDENT & EMERGENCY MEDICINE

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2016-011826

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