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.
Endobronchial VAlves for Pneumothorax On Reducing Admission Time (EVAPORATe) – a pilot feasibility randomised clinical trial
Institute of Respiratory Health
40 participants
Nov 11, 2025
Interventional
Conditions
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
Eligibility
Inclusion Criteria1
- 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.
Exclusion Criteria4
- Age <18yrs.
- Inability to consent or to comply with the protocol.
- 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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Interventions
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.
Locations(1)
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ACTRN12625000360415