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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.
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Scientific title
Endobronchial VAlves for Pneumothorax On Reducing Admission Time (EVAPORATe)
– a pilot feasibility randomised clinical trial
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Secondary ID [1]
312479
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None
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Universal Trial Number (UTN)
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Trial acronym
EVAPORATe
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Persistent air-leak
334332
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Pneumothorax
334330
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Secondary pneumothorax
334331
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Condition category
Condition code
Respiratory
330985
330985
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0
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Chronic obstructive pulmonary disease
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Respiratory
330986
330986
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0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
328996
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Treatment: Devices
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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The primary aim is to assess the feasibility of the study protocol.
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Assessment method [1]
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The protocol feasibility is the composite primary outcome, measured with the following: 1. Recruitment rate i.e. number patients enrolled in a month 2. Adherence: Adherence to the intervention arm, i.e. number of patients randomized to the interventional arm that are referred/assessed for EBV and those that have EBV placed 3. Retention: Retention at follow-up and reasons for dropout The outcomes are assessed by reviewing patients, data from patient medical records, and by reviewing patient study enrolment and withdrawal logs.
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Timepoint [1]
338748
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Participants will be followed for a maximum of 6 months from the day of hospital discharge
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Secondary outcome [1]
445449
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Removal of EBVs
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Assessment method [1]
445449
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In cases where EBVs are removed post-insertion, the reasons and timing of this removal will be documented. The outcomes are assessed by reviewing patients and by reviewing data from patient medical records.
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Timepoint [1]
445449
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Participants will be followed for a maximum of 6 months from hospital discharge
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Secondary outcome [2]
445452
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Survival Data
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Assessment method [2]
445452
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We will track survival rates and causes of death, if any, until the end of the trial period, which is six months from randomization.
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Timepoint [2]
445452
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Participants will be followed for a maximum of 6 months from hospital discharge
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Secondary outcome [3]
445446
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Recurrence of Pneumothorax
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Assessment method [3]
445446
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New instances of pneumothorax is a composite secondary outcome. We will track any new instances of pneumothorax, either on the same side (ipsilateral) or the opposite side (contralateral), as confirmed by chest radiographs, within six months post-treatment. If pneumothorax is still present at discharge, its worsening that necessitates further procedures will be considered a recurrence. The outcomes are assessed by reviewing patients and by reviewing data from patient medical records.
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Timepoint [3]
445446
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Participants will be followed for a maximum of 6 months from hospital discharge
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Secondary outcome [4]
437276
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Total length of stay (LoS):
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Assessment method [4]
437276
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The length of stay (LoS) in the hospital from the date of admission to the hospital with pneumothorax to the date of discharge. This includes all hospital stays related to PAL and its treatment during the study period, encompassing all reasons for hospital admissions. Details such as the number of admissions, their reasons, and durations will be documented. The time spent in the hospital will be further divided into periods related to PAL and/or EBV (including complications), and periods for reasons unrelated to these conditions. The outcomes will be assessed as a composite outcome and are assessed by reviewing patients and by reviewing data from patient medical records.
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Timepoint [4]
437276
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Participants will be followed for a maximum of 6 months from hospital discharge
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Secondary outcome [5]
445451
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Resource Utilization
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Assessment method [5]
445451
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This will include capturing complications related to both in-patient and out-patient management from hospital records or self-reports, encompassing treatments, imaging, and other interventions linked to adverse events. An experienced health economist will oversee this aspect of the study. The “Self-reports” method of assessment refers to any information about complications that patients share with their healthcare team during follow-up appointments. Patients can report these complications (if present) through health records or via conversations (directly to the trial team members during follow-ups or indirectly via GP).
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Timepoint [5]
445451
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Participants will be followed for a maximum of 6 months from hospital discharge
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Secondary outcome [6]
445445
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Time to Chest Drain Removal
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Assessment method [6]
445445
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The duration, in days, for chest tube removal will be recorded, starting from the time of randomization and the initial radiographic evidence of pneumothorax. The outcomes are assessed by reviewing patients and by reviewing data from patient medical records.
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Timepoint [6]
445445
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Participants will be followed for a maximum of 6 months from hospital discharge
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Secondary outcome [7]
445444
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Time to Cessation of Air Leak
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Assessment method [7]
445444
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This will be measured from the point of randomisation and from the first radiographic evidence of pneumothorax, based on clinical assessments by the attending medical team. The outcomes are assessed by reviewing patients and by reviewing data from patient medical records.
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Timepoint [7]
445444
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Participants will be followed for a maximum of 6 months from hospital discharge
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Secondary outcome [8]
445450
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Performance (ECOG) status
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Assessment method [8]
445450
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ECOG is the Eastern Cooperative Oncology Group status to assess the functional status and will be captured post-discharge and during follow-up clinic visits at 1, 3, and 6 months.
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Timepoint [8]
445450
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Participants will be reviewed during follow-up clinic visits at 1, 3, and 6 months post hospital discharge.
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Secondary outcome [9]
445443
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Composite secondary outcome: Interventions for PAL Management and EBV Complications
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Assessment method [9]
445443
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We will record all additional pulmonary or pleural procedures required for managing PAL, such as pleurodesis and blood patches, and interventions to address complications arising from EBV, like unscheduled removal due to respiratory failure. The outcomes are assessed by reviewing patients and by reviewing data from patient medical records.
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Timepoint [9]
445443
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Participants will be followed for a maximum of 6 months from hospital discharge
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Age <18yrs.
2. Inability to consent or to comply with the protocol.
3. Hemodynamically instability^.
^ Hemodynamic instability is defined as requiring vasopressors/inotropes to maintain mean arterial pressure >60mmHg, respiratory support including non-invasive ventilation or invasive mechanical ventilation with high oxygen (>60% FiO2), and haemoptysis necessitating blood transfusion.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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
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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
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
13/06/2025
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Actual
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Date of last participant enrolment
Anticipated
31/10/2026
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Actual
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Date of last data collection
Anticipated
30/04/2027
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Actual
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Sample size
Target
40
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
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Funding & Sponsors
Funding source category [1]
316897
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Commercial sector/Industry
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Name [1]
316897
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Pulmonx
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Address [1]
316897
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Country [1]
316897
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Australia
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Funding source category [2]
316896
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Charities/Societies/Foundations
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Name [2]
316896
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Institute of Respiratory Health
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Address [2]
316896
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Country [2]
316896
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Australia
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Primary sponsor type
Charities/Societies/Foundations
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Name
Institute of Respiratory Health
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Address
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Country
Australia
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Secondary sponsor category [1]
319147
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Commercial sector/Industry
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Name [1]
319147
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Pulmonx
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Address [1]
319147
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Country [1]
319147
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Australia
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
315658
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Royal Australian College of General Practitioners National Research and Evaluation Ethics Committee
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Ethics committee address [1]
315658
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https://www.racgp.org.au/the-racgp/governance/committees/national-committees
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Ethics committee country [1]
315658
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Australia
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Date submitted for ethics approval [1]
315658
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04/04/2025
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Approval date [1]
315658
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Ethics approval number [1]
315658
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Summary
Brief summary
The Endobronchial VAlves for Pneumothorax On Reducing Admission Time (EVAPORATe) study is a pilot feasibility multi-centre randomized controlled trial (RCT) to investigate if an early referral of patients with PAL from SSP for EBV can help shorten total length of hospital stay. The pilot data will inform in protocol feasibility and power calculation for the next stage (full-scale) RCT
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Y C Gary Lee
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Address
135402
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UWA School of Medicine 533 Harry Perkins Building QE II Medical Centre Perth WA 6009
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Country
135402
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Australia
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Phone
135402
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+61 861510913
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Fax
135402
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Email
135402
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[email protected]
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Contact person for public queries
Name
135403
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Y C Gary Lee
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Address
135403
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UWA School of Medicine 533 Harry Perkins Building QE II Medical Centre Perth WA 6009
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Country
135403
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Australia
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Phone
135403
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+61 861510913
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Fax
135403
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Email
135403
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[email protected]
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Contact person for scientific queries
Name
135404
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Y C Gary Lee
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Address
135404
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UWA School of Medicine 533 Harry Perkins Building QE II Medical Centre Perth WA 6009
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Country
135404
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Australia
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Phone
135404
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+61 861510913
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Fax
135404
0
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Email
135404
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[email protected]
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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.
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