Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000798369
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
7/06/2026
Date registered
Help: Date registered
3/07/2026
Date last updated
Help: Date last updated
3/07/2026
Date data sharing statement initially provided
Help: Data sharing statement date
3/07/2026
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
Is Ultrasound as accurate as Chest Xray for detecting remaining lung collapse after chest drain removal following chest injury
Scientific title
Validation of Ultrasound for Detecting Post-Tube Thoracostomy Removal for Traumatic Pneumothorax compared with Chest Xray
Additional trial identifiers [1] 317501 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Traumatic pneumothorax 342233 0
Condition category
Condition code
Injuries and Accidents 338353 338353 0 0
Other injuries and accidents
Respiratory 338490 338490 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Current practice is to obtain a chest X-ray (CXR) four hours after removal of a an intercostal catheter to assess residual pneumothorax in patients with traumatic pneumothorax. In this study an ultrasound (US) will be performed prior to the CXR to compare the accuracy of the US.

CXR is current standard of care. The US will be performed by registrars or specialists who at a minimum have completed the Australasian College for Emergency Medicine training module on lung US. This will be completed in the ward prior the patient having their routine post chest drain removal CXR.

The ultrasound will be performed immediately prior to the CXR approximately 4 hours post removal of the intercostal catheter. Ultrasound is performed by applying a probe with ultrasound gel directly to the patients skin over the area of lung to be examined. Training to operate the ultrasound in interpret the findings is straightforward, generally taking about 30mins. The ultrasound examination required for the study takes less than 5mins to complete. All scans are reviewed by a senior clinician to ensure correct interpretation.

The concept to "washout" it not really applicable to this study as it is a study of a diagnostic test rather than a treatment, with the CXR performed as soon as possible after the ultrasound has been performed.
Intervention code [1] 334294 0
Diagnosis / Prognosis
Description of the comparator or control
Patients form their own control.

CXR is the control imaging for ultrasound which is the intervention. CXR is performed by radiographers in the medical imaging department. The CXR is done in the medical imaging department usually taking less 5mins to complete. The patient stands up with their chest against the Xray plate and an image is taken.
Control group
Active

Outcomes
Primary outcome [1] 345670 0
To validate the use of US in detecting clinically concerning residual pneumothorax in trauma patients with compared with CXR findings (formal report)
Timepoint [1] 345670 0
Four hours post chest drain removal
Secondary outcome [1] 462802 0
Evaluate patient satisfaction with US compared to CXR for residual pneumothorax assessment
Timepoint [1] 462802 0
4 hours post chest drain removal as soon as practicable after the ultrasound and CXR have been completed.
Secondary outcome [2] 462803 0
Assess the inter-rater reliability of US image interpretation among trained operators
Timepoint [2] 462803 0
At convenient intervals throughout the recruitment phase, eg after enrolment of 20 patients
Secondary outcome [3] 462804 0
Patient positioning
Timepoint [3] 462804 0
4 hours post chest drain removal
Secondary outcome [4] 463276 0
Patient body mass index
Timepoint [4] 463276 0
At convenience from the patients medical record. This will be collected at the time the ultrasound and CXR are performed.

Eligibility
Key inclusion criteria
Adult patients with traumatic pneumothorax who are able to consent to inclusion in the study. Patients must have had a chest drain placed for management of the pneumothorax.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Inability to provide informed consent (e.g., intubated patients, GCS < 13, patient not passing post-traumatic amnesia (PTA) screening, cognitive impairment, non-English speaking).

Patients with pre-existing conditions that may confound the interpretation of lung ultrasound (e.g. severe COPD, lung fibrosis).

Patients with persisting PTX despite chest drain placement

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
2/09/2025
Date of last participant enrolment
Anticipated
31/12/2027
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
100
Accrual to date
20
Final
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 29610 0
Royal Hobart Hospital - Hobart
Recruitment postcode(s) [1] 45940 0
7000 - Hobart

Funding & Sponsors
Funding source category [1] 322071 0
Hospital
Name [1] 322071 0
Royal Hobart Hospital
Country [1] 322071 0
Australia
Primary sponsor type
Individual
Name
Dr Rohan Lynham, Royal Hobart Hospital
Address
Country
Australia
Secondary sponsor category [1] 324952 0
None
Name [1] 324952 0
Address [1] 324952 0
Country [1] 324952 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320600 0
Tasmanian Low Risk Human Research Ethics Committee
Ethics committee address [1] 320600 0
Ethics committee country [1] 320600 0
Australia
Date submitted for ethics approval [1] 320600 0
08/07/2025
Approval date [1] 320600 0
13/08/2025
Ethics approval number [1] 320600 0
2025/ETH01515

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 151014 0
Dr Rohan Lynham
Address 151014 0
Dept of Anesthesia, Royal Hobart Hospital, Liverpool St, Hobart, Tasmania, 7000
Country 151014 0
Australia
Phone 151014 0
+61 03 61666130
Fax 151014 0
Email 151014 0
[email protected]
Contact person for public queries
Name 151015 0
Kim Lecuyer
Address 151015 0
Trauma Service, Royal Hobart Hospital, Liverpool St, Hobart, Tasmania, 7000
Country 151015 0
Australia
Phone 151015 0
+61 03 61668308
Fax 151015 0
Email 151015 0
[email protected]
Contact person for scientific queries
Name 151016 0
Kim Lecuyer
Address 151016 0
Trauma Service, Royal Hobart Hospital, Liverpool St, Hobart, Tasmania, 7000
Country 151016 0
Australia
Phone 151016 0
+61 03 61668308
Fax 151016 0
Email 151016 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
A finite period of: 7 years
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol    Project Protocol_US rPTX Validation Study v2_07Aug25.docx


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.