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Trial registered on ANZCTR


Registration number
ACTRN12625000360415p
Ethics application status
Submitted, not yet approved
Date submitted
31/03/2025
Date registered
24/04/2025
Date last updated
24/04/2025
Date data sharing statement initially provided
24/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Utility of one-way valves in the airways to treat pneumothorax (collapse of the lung) that can help in shortening the duration of stay in hospital.
Scientific title
Endobronchial VAlves for Pneumothorax On Reducing Admission Time (EVAPORATe)
– a pilot feasibility randomised clinical trial
Secondary ID [1] 312479 0
None
Universal Trial Number (UTN)
Trial acronym
EVAPORATe
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pneumothorax 334330 0
Secondary pneumothorax 334331 0
Persistent air-leak 334332 0
Condition category
Condition code
Respiratory 330985 330985 0 0
Chronic obstructive pulmonary disease
Respiratory 330986 330986 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly assigned (1:1) to either:

a. Early Endobronchial Valves (EBV) Referral arm
Patients with persistent air leak (PAL) will be assessed by an interventional clinician for EBV placement at the earliest feasible time after a minimum of 96 hours from the first radiographic evidence of a pneumothorax. The risks and benefits of the procedure will be explained to the patients by the clinical team performing the procedure.

The decision to proceed to EBV insertion will be that of the interventionalist. Should there be clinical reasons not to proceed to EBV insertion (e.g., inconsistent air leak to guide valve placement, unable to tolerate sedation/anaesthesia), the patient will be assessed regularly for suitability of EBV treatment until the air leak heals or the interventional clinician must provide a reason that will be documented in the patient file and research notes.

EBV is a one-way valve that can facilitate the closure of air leaks by preventing air entry to the airways of the lung (and thus also the pleural space). It contributes to sealing the leak, or a significant reduction in its size to enhance natural healing and promote lung expansion.
It is inserted into the relevant airway(s) of the lung affected by PAL using a flexible bronchoscope. EBV placement is usually performed under general anaesthesia but can also be inserted under mild to moderate sedation if required. Once inserted, it will be left in situ until the air leak has stopped. Often multiple valves (typically 3) are needed during each procedure. EBVs could be removed once the leak has healed. This will be decided by the treating doctors during follow-up visits. Removal of EBVs are done under general anaesthesia, or sometimes under sedation, in the operating theatre.


b. Standard care arm

Patients randomized to this group will be managed conventionally by the attending team. Standard care will usually involve conventional care of chest drain until the air leak heals. Additional procedures, such as bedside chest tube pleurodesis and blood patch treatment, can be undertaken if the attending team considers them appropriate. EBV is allowed if considered appropriate by the attending team if air leak persists after 12 days. This time is chosen based on the median time of EBV insertion (as a rescue procedure) in an audit of Western Australian hospital practice, and is consistent with literature data; thus, patients enrolled in the study will not be disadvantaged.

Participants in both arms will be managed by their clinical teams and receive all other medical treatments as deemed clinically appropriate. Patients’ medical care, including drain care and other medical management, will be directed by their attending physicians, as per standard practice in the treatment hospital, regardless of study group allocation. All participants and carers will have access to the trial research staff via a direct phone line should any concerns arise.

All clinical decisions, such as the need for additional procedures, removal of chest drain, and subsequent removal of EBV, are the responsibility of the attending clinicians, according to the clinical need of the patient.
Intervention code [1] 328996 0
Treatment: Devices
Comparator / control treatment
Standard care arm

Patients randomized to this group will be managed conventionally by the attending team. Standard care will usually involve conventional care of chest drain until the air leak heals. Additional procedures, such as bedside chest tube pleurodesis and blood patch treatment, can be undertaken if the attending team considers them appropriate. EBV is allowed if considered appropriate by the attending team if air leak persists after 12 days. This time is chosen based on the median time of EBV insertion (as a rescue procedure) in an audit of Western Australian hospital practice, and is consistent with literature data; thus, patients enrolled in the study will not be disadvantaged.
Participants in both arms will be managed by their clinical teams and receive all other medical treatments as deemed clinically appropriate. Patients’ medical care, including drain care and other medical management, will be directed by their attending physicians, as per standard practice in the treatment hospital, regardless of study group allocation. All participants and carers will have access to the trial research staff via a direct phone line should any concerns arise.

All clinical decisions, such as the need for additional procedures, removal of chest drain, and subsequent removal of EBV, are the responsibility of the attending clinicians, according to the clinical need of the patient.
Control group
Active

Outcomes
Primary outcome [1] 338748 0
The primary aim is to assess the feasibility of the study protocol.
Timepoint [1] 338748 0
Participants will be followed for a maximum of 6 months from the day of hospital discharge
Secondary outcome [1] 437276 0
Total length of stay (LoS):
Timepoint [1] 437276 0
Participants will be followed for a maximum of 6 months from hospital discharge
Secondary outcome [2] 445443 0
Composite secondary outcome: Interventions for PAL Management and EBV Complications
Timepoint [2] 445443 0
Participants will be followed for a maximum of 6 months from hospital discharge
Secondary outcome [3] 445444 0
Time to Cessation of Air Leak
Timepoint [3] 445444 0
Participants will be followed for a maximum of 6 months from hospital discharge
Secondary outcome [4] 445445 0
Time to Chest Drain Removal
Timepoint [4] 445445 0
Participants will be followed for a maximum of 6 months from hospital discharge
Secondary outcome [5] 445446 0
Recurrence of Pneumothorax
Timepoint [5] 445446 0
Participants will be followed for a maximum of 6 months from hospital discharge
Secondary outcome [6] 445449 0
Removal of EBVs
Timepoint [6] 445449 0
Participants will be followed for a maximum of 6 months from hospital discharge
Secondary outcome [7] 445450 0
Performance (ECOG) status
Timepoint [7] 445450 0
Participants will be reviewed during follow-up clinic visits at 1, 3, and 6 months post hospital discharge.
Secondary outcome [8] 445451 0
Resource Utilization
Timepoint [8] 445451 0
Participants will be followed for a maximum of 6 months from hospital discharge
Secondary outcome [9] 445452 0
Survival Data
Timepoint [9] 445452 0
Participants will be followed for a maximum of 6 months from hospital discharge

Eligibility
Key inclusion criteria
Patients with a pneumothorax of any cause with ongoing air leak for at least 96 hours (four days) and who are not suitable or unwilling to receive surgical management.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Age 60mmHg, respiratory support including non-invasive ventilation or invasive mechanical ventilation with high oxygen (>60% FiO2), and haemoptysis necessitating blood transfusion.

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)
An automated centralized web-based randomization scheme will be setup and managed by the Griffith Randomisation Service (Griffith University, QLD, Australia). Randomization will be available 24 hours a day, following the entry of baseline and minimization data. Enrolment will be confirmed by emails sent to the enrolling and the lead sites
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An automated centralized web-based randomization scheme will be setup and managed by the Griffith Randomisation Service (Griffith University, QLD, Australia). Randomization will be available 24 hours a day, following the entry of baseline and minimization data. Enrolment will be confirmed by emails sent to the enrolling and the lead sites
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/06/2025
Actual
Date of last participant enrolment
Anticipated
31/10/2026
Actual
Date of last data collection
Anticipated
30/04/2027
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC

Funding & Sponsors
Funding source category [1] 316896 0
Charities/Societies/Foundations
Name [1] 316896 0
Institute of Respiratory Health
Country [1] 316896 0
Australia
Funding source category [2] 316897 0
Commercial sector/Industry
Name [2] 316897 0
Pulmonx
Country [2] 316897 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Institute of Respiratory Health
Address
Country
Australia
Secondary sponsor category [1] 319147 0
Commercial sector/Industry
Name [1] 319147 0
Pulmonx
Address [1] 319147 0
Country [1] 319147 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315658 0
Royal Australian College of General Practitioners National Research and Evaluation Ethics Committee
Ethics committee address [1] 315658 0
Ethics committee country [1] 315658 0
Australia
Date submitted for ethics approval [1] 315658 0
04/04/2025
Approval date [1] 315658 0
Ethics approval number [1] 315658 0

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

Contacts
Principal investigator
Name 135402 0
Prof Y C Gary Lee
Address 135402 0
UWA School of Medicine 533 Harry Perkins Building QE II Medical Centre Perth WA 6009
Country 135402 0
Australia
Phone 135402 0
+61 861510913
Fax 135402 0
Email 135402 0
[email protected]
Contact person for public queries
Name 135403 0
Y C Gary Lee
Address 135403 0
UWA School of Medicine 533 Harry Perkins Building QE II Medical Centre Perth WA 6009
Country 135403 0
Australia
Phone 135403 0
+61 861510913
Fax 135403 0
Email 135403 0
[email protected]
Contact person for scientific queries
Name 135404 0
Y C Gary Lee
Address 135404 0
UWA School of Medicine 533 Harry Perkins Building QE II Medical Centre Perth WA 6009
Country 135404 0
Australia
Phone 135404 0
+61 861510913
Fax 135404 0
Email 135404 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided



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.