Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000184976
Ethics application status
Approved
Date submitted
14/02/2011
Date registered
16/02/2011
Date last updated
22/03/2022
Date data sharing statement initially provided
22/03/2022
Date results information initially provided
22/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A study to investigate the treatment of pneumothorax (collapsed lung)
Scientific title
A randomised controlled trial of conservative versus interventional treatment of primary spontaneous pneumothorax
Secondary ID [1] 253154 0
Nil
Universal Trial Number (UTN)
U1111-1118-2820
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary spontaneous pneumothorax 258702 0
Condition category
Condition code
Respiratory 258855 258855 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Conservative management of primary spontaneous pneumothorax. Subjects will be observed for 4 hours in the emergency department and a repeat x-ray taken. If they are clinically stable and able to mobilise comfortably they will be discharged home and followed as an outpatient with a review at 24-72 hours, and at 2, 4 and 8 weeks.
Intervention code [1] 257658 0
Treatment: Other
Comparator / control treatment
Standard interventional treatment of primary spontaneous pneumothorax. A small bore (less than or equal to 12Fr) Seldinger chest drain will be inserted. If aspiration is unsuccessful underwater drainage will continue and the patient will be admitted to hospital. Further management, including the use of suction or need for surgery, will be at the discretion of the treating physician
Control group
Active

Outcomes
Primary outcome [1] 259711 0
Proportion of subjects with complete lung re-expansion on chest xray
Timepoint [1] 259711 0
8 weeks after randomisation
Secondary outcome [1] 266427 0
Time in days to symptomatic recovery, defined as: discharge from hospital and resolution of symptoms (chest pain score of 0 on a 1-10 visual analogue scale and shortness of breath score of 0 on the Borg scale) and cessation of analgesic medication.
Timepoint [1] 266427 0
Time post-randomisation
Secondary outcome [2] 266428 0
Proportion of subjects with a predefined complication of interventional treatment including:
Tension pneumothorax
Haemothorax
Trauma to heart, liver, spleen or gut
Foreign body in chest wall
Foreign body in chest cavity
Infection- skin and subcutaneous tissues treated with antibiotics
Infection- empyema treated with antibiotics
Infection- pneumonia treated with antibiotics
Sepsis (likely infection +2 or more of; temp >38 or <36, HR>90, RR>20, WCC>12 or <4)
Timepoint [2] 266428 0
8 weeks after randomisation
Secondary outcome [3] 266429 0
Proportion of subjects with pneumothorax recurrence. Subjects will be contacted by telephone 12 months after randomisation to ask about repeat episodes of pneumothorax. In addition, a search of Clinical Information Systems and review of admission/ED attendance records will be made
Timepoint [3] 266429 0
Up to 5 years post-randomisation. Subjects will recieve a phone call at 6 months and then yearly for 5 years
Secondary outcome [4] 273205 0
Proportion of subjects with persistent air leak, defined by the presence of a chest drain/catheter in situ for 3 days or longer.
Timepoint [4] 273205 0
8 weeks after randomisation
Secondary outcome [5] 338757 0
Number of hospital bed days according to hospital records
Timepoint [5] 338757 0
8 weeks after randomisation
Secondary outcome [6] 338758 0
Number of procedures and investigations required includeing total number of chest x-rays and CT scans (according to hospital records)
Timepoint [6] 338758 0
8 weeks after randomisation
Secondary outcome [7] 338759 0
Days off work due to pneumothorax. No specific tools used, This information is captured on the patient questionnaire at each study visit. Added prior to enrollment of any subjects.
Timepoint [7] 338759 0
8 weeks post randomisation
Secondary outcome [8] 338760 0
Self rated patient satisfaction. This is captured using a 6 point Likert scale on the patient questionnaire.
Timepoint [8] 338760 0
8 weeks post randomisation

Eligibility
Key inclusion criteria
Primary spontaneous pneumothorax that is 32% or larger (using method of Collins et al Am J Roentgenol. 1995; 165: 1127-30)
Minimum age
14 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Secondary pneumothorax, defined as pneumothorax occurring in the setting of acute trauma (including iatrogenic) or underlying lung disease including but not limited to COPD, pulmonary fibrosis, TB, cystic fibrosis, lung cancer and asthma that requires regular preventative medication or has been symptomatic within the last two years 2. Previous spontaneous pneumothorax on the same side 3. Coexistent haemothorax (i.e. spontaneous haemopneumothorax) 4. Bilateral pneumothorax 5. Clinical instability suggesting tension pneumothorax; respiratory distress persisting despite oxygen and parenteral narcotic analgesia (RR >30/min or SpO2 <90%), SBP <90 mmHg, HR greater than or equal to SBP. 6. Pregnancy at time of enrolment 7. Social circumstances whereby the patient either does not have adequate support after discharge to re-attend hospital if required, or is unlikely to present for study follow up. 8. Air travel within the next 12 weeks if this cannot be deferred should the pneumothorax be slow to resolve"

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects will be randomised using a secure, centralised web-based randomisation system. The group allocation will only be revealed when the investigator confirms inclusion criteria have been met and enters the subjects details
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects will be randomised in real time by computer, stratified by study site, using an adaptive biased coin (Urn) technique
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Non-inferiority trial
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
14/07/2011
Actual
14/07/2011
Date of last participant enrolment
Anticipated
Actual
12/03/2017
Date of last data collection
Anticipated
12/05/2022
Actual
Sample size
Target
342
Accrual to date
Final
323
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA,VIC
Recruitment hospital [1] 8996 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 8997 0
Gold Coast Hospital - Southport
Recruitment hospital [3] 8998 0
Cairns Base Hospital - Cairns
Recruitment hospital [4] 8999 0
St George Hospital - Kogarah
Recruitment hospital [5] 9000 0
The Prince Charles Hospital - Chermside
Recruitment hospital [6] 9001 0
Armadale Kelmscott Memorial Hospital - Armadale
Recruitment hospital [7] 9002 0
The Townsville Hospital - Douglas
Recruitment hospital [8] 9003 0
Toowoomba Hospital - Toowoomba
Recruitment hospital [9] 9004 0
The Sutherland Hospital - Caringbah
Recruitment hospital [10] 9005 0
Rockingham General Hospital - Cooloongup
Recruitment hospital [11] 9006 0
Bunbury Hospital - Bunbury
Recruitment hospital [12] 9007 0
Ipswich Hospital - Ipswich
Recruitment hospital [13] 9008 0
Swan Districts Hospital - Middle Swan
Recruitment hospital [14] 9009 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [15] 9010 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [16] 9011 0
Royal Perth Hospital - Perth
Recruitment hospital [17] 9012 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [18] 9013 0
Bundaberg Hospital - Bundaberg
Recruitment hospital [19] 9014 0
John Hunter Hospital Royal Newcastle Centre - New Lambton
Recruitment hospital [20] 9015 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [21] 9016 0
Blacktown Hospital - Blacktown
Recruitment hospital [22] 9017 0
Box Hill Hospital - Box Hill
Recruitment hospital [23] 9018 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [24] 9019 0
Dandenong Hospital - Dandenong
Recruitment hospital [25] 9020 0
Casey Hospital - Berwick
Recruitment hospital [26] 9021 0
Nambour General Hospital - Nambour
Recruitment outside Australia
Country [1] 3064 0
New Zealand
State/province [1] 3064 0
Auckland
Country [2] 3065 0
New Zealand
State/province [2] 3065 0
Hamilton
Country [3] 3066 0
New Zealand
State/province [3] 3066 0
Wellington
Country [4] 3067 0
New Zealand
State/province [4] 3067 0
Christchurch
Country [5] 9210 0
New Zealand
State/province [5] 9210 0
Christchurch
Country [6] 9211 0
New Zealand
State/province [6] 9211 0
Middlemore
Country [7] 9212 0
New Zealand
State/province [7] 9212 0
Waikato

Funding & Sponsors
Funding source category [1] 258127 0
Government body
Name [1] 258127 0
National Health and Medical Research Council
Country [1] 258127 0
Australia
Funding source category [2] 297509 0
Government body
Name [2] 297509 0
Health Research Council of New Zealand
Country [2] 297509 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Medical Research Institute of New Zealand
Address
Private Bag 7902
Wellington 6242
Country
New Zealand
Secondary sponsor category [1] 257302 0
Hospital
Name [1] 257302 0
Centre for Clinical Research in Emergency Medicine
Address [1] 257302 0
Department of Emergency Medicine
Royal Perth Hospital
GPO Box X2213
Perth, WA 6001
Country [1] 257302 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260108 0
The Royal Perth Hospital Ethics Committee
Ethics committee address [1] 260108 0
Level 5, Colonial House
Royal Perth Hospital
Wellington Street
Perth WA 6000
Ethics committee country [1] 260108 0
Australia
Date submitted for ethics approval [1] 260108 0
22/09/2010
Approval date [1] 260108 0
09/11/2010
Ethics approval number [1] 260108 0
EC 2010/100
Ethics committee name [2] 298608 0
New Zealand Health and Disability Ethics Committee
Ethics committee address [2] 298608 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington
Ethics committee country [2] 298608 0
New Zealand
Date submitted for ethics approval [2] 298608 0
05/01/2011
Approval date [2] 298608 0
01/07/2011
Ethics approval number [2] 298608 0
MEC/11/01/003

Summary
Brief summary
Primary spontaneous pneumothorax occurs when a lung collapses due to air escaping from a small hole in the surface lining. It occurs predominantly in young people who have no other lung disease. The symptoms are variable but may include chest pain and breathlessness. Currently the treatment recommended by international guidelines is to try to remove the air from the chest and re-expand the lung by inserting a plastic tube through the chest wall. This is done using local anaesthetic but can be uncomfortable and may be associated with complications. It may take up to a week for the lung to re-inflate, during which time the patient must remain in hospital. In some cases air continues to leak out of the lung and surgery is required. However, there are historical reports suggesting that simply observing a pneumothorax and allowing it to re-expand slowly may be as effective as inserting a tube in hospital, although it may take 4-6 weeks to fully resolve. This study will compare the current standard treatment using a tube, to simple observation, in a group of 342 patients with pneumothorax. The proportion in each group who have resolved on an X-ray at 8 weeks will be compared.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31948 0
Prof Simon Brown
Address 31948 0
Centre for Medical Research, UWA (CMR)
The University of Western Australia (M516)
35 Stirling Highway
CRAWLEY WA 6009
Australia
Country 31948 0
Australia
Phone 31948 0
+61 8 9224 2662
Fax 31948 0
Email 31948 0
[email protected]
Contact person for public queries
Name 15195 0
Dr Kyle Perrin
Address 15195 0
Wellington Hospital
Private Bag 7902
Wellington South
New Zealand
Country 15195 0
New Zealand
Phone 15195 0
+64 4 8062175
Fax 15195 0
+64 4 3895427
Email 15195 0
[email protected]
Contact person for scientific queries
Name 6123 0
Dr Kyle Perrin
Address 6123 0
Wellington Hospital
Private Bag 7902
Wellington South
New Zealand
Country 6123 0
New Zealand
Phone 6123 0
+64 4 8062175
Fax 6123 0
+64 4 3895427
Email 6123 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All trial data
When will data be available (start and end dates)?
From August 2020, no end date
Available to whom?
Open to any member of the public
Available for what types of analyses?
Any analysis
How or where can data be obtained?
Online via the University of Western Australia (UWA) Research Repository

https://research-repository.uwa.edu.au/en/datasets/conservative-versus-interventional-treatment-for-spontaneous-pneu


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15484Study protocol https://bmjopen.bmj.com/content/6/9/e011826 
15485Statistical analysis plan https://research-repository.uwa.edu.au/en/datasets/statistical-analysis-plan-for-the-psp-trial-a-randomised-controll 



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes N Engl J Med 2020; 382:405-415 January 30, 2020
Basic resultsNo 336270-(Uploaded-11-03-2022-12-16-21)-Basic results summary.docx
Plain language summaryNo The novel treatment approach of observation was as... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseManagement of primary spontaneous pneumothorax by intensivists: an international survey.2016https://dx.doi.org/10.1007/s00134-016-4436-y
EmbaseConservative versus interventional treatment for spontaneous pneumothorax.2020https://dx.doi.org/10.1056/NEJMoa1910775
Dimensions AIStudy protocol for a randomised controlled trial of invasive versus conservative management of primary spontaneous pneumothorax2016https://doi.org/10.1136/bmjopen-2016-011826
Dimensions AIRandomised comparison of needle aspiration and chest tube drainage in spontaneous pneumothorax2017https://doi.org/10.1183/13993003.01296-2016
N.B. These documents automatically identified may not have been verified by the study sponsor.