[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589846":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":25,"locations":34,"responsibleParty":52,"collaborators":12,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":12,"enrollmentInfo":64,"targetDuration":12,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":76,"overallStatus":37,"whyStopped":12,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Cambridge University Hospitals NHS Foundation Trust","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard practice","NO_INTERVENTION","Fluid drainage will be performed according to standard practice, with cessation of fluid removal at the first sign of patient discomfort to prevent pain.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Air Entrainment","EXPERIMENTAL","During pleural effusion drainage, atmospheric air will be intentionally introduced into the pleural space by opening the 3-way tap to air. This aims to reduce excessive negative pressure, which can create a vacuum effect within the pleural space and is thought to contribute to patient pain during drainage. The tap allows controlled air entry without fluid leakage, helping to minimise pain while maintaining safe drainage.",[18],"Procedure: Air Entrainment - intentional introduction of the atmospheric air into the pleural space.",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"PROCEDURE","Air Entrainment - intentional introduction of the atmospheric air into the pleural space.","This intervention is distinct in that it uses a standard 3-way tap, already present in routine pleural drainage procedures, to intentionally introduce atmospheric air into the pleural space in a controlled and repeatable manner. Unlike other studies where air entrainment may occur incidentally or as part of more invasive procedures, this method specifically utilises precise manipulation of the tap handle to allow intermittent air entry, aiming to reduce negative intrapleural pressure and associated pain during fluid drainage. Air entry is carefully controlled, can be repeated up to five times per procedure, and does not interfere with fluid drainage or introduce additional equipment or complexity.",[14],[26,31],{"name":27,"role":28,"phone":29,"phoneExt":12,"email":30},"Emilia M SWIETLIK, MD PhD","CONTACT","+447736750560","e.swietlik@nhs.net",{"name":32,"role":28,"phone":12,"phoneExt":12,"email":33},"Jurgen Herre, PhD","jurgen.herre1@nhs.net",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Addenbrooke's Hospital","RECRUITING","Cambridge","Cambridgeshire","CB2 0BB","United Kingdom","UK",{"type":44,"coordinates":45},"Point",[46,47],0.11667,52.2,{"lat":47,"lon":46},[50],{"name":12,"role":28,"phone":51,"phoneExt":12,"email":12},"07736750560",{"type":53,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR","100589846","armstrong---air-entrainment-vs-standard-treatment-in-non-expandable-lung-100589846",false,"NCT06959719","ARMSTRONG - Air entRainMent vS sTandard tReatment in nOn-expandable luNG","Air Entrainment vs. Standard Treatment in Non-Expandable Lung With Persistent Pleural Effusion: A Randomised Controlled Double-Blind Trial","ARMSTRONG","Inclusion Criteria:\n\n* Adults aged 18 years or older with a suspected or confirmed diagnosis of NEL and persistent pleural effusion.\n* Patients who are scheduled for pleural effusion drainage as part of their standard care.\n* Ability to adequately understand verbal or written information in English and provide informed consent in English.\n\nExclusion Criteria:\n\n* Patients with a history of pleurodesis or other procedures that may affect pleural dynamics.\n* Patients with active infections or other acute medical conditions that could interfere with the study.\n* Patient with multifactorial pain and high baseline score pain defined as VAS \\>= 5\n* Patients requiring IPC\n* Individuals with known contraindications to pleural drainage or air entrainment.\n* Patients who cannot provide informed consent in English, do not adequately understand verbal or written information in English or have special communication needs.","ALL","18 Years",{"count":65,"type":66},41,"ESTIMATED","INTERVENTIONAL",[69],"NA","This is a randomised controlled trial evaluating whether controlled air introduction into pleural space (air entrainment) during pleural effusion drainage reduces pain, improves patient satisfaction, and facilitates more effective drainage in patients with non-expandable lung (NEL).\n\nNEL lung is a common complication in patients with malignant or chronic pleural effusions, where the lung fails to fully re-expand after fluid removal due to pleural disease or fibrosis. In these patients, drainage often creates excessive negative pressure within the pleural cavity, leading to pain, vasovagal episodes, early termination of drainage, and the need for repeated procedures.\n\nThis study investigates a simple, safe, and low-cost intervention using a standard 3-way tap attached to the drainage system. By intermittently opening the tap to atmospheric air during drainage, air enters the pleural cavity in a controlled fashion, reducing negative pressure and potentially reducing pain, improving drainage tolerance, and minimising the need for repeated procedures.\n\nPleural effusion drainage is a common procedure in patients with advanced malignancy or chronic pleural disease. In patients with NEL, fluid removal creates a vacuum effect within the pleural space due to the inability of the lung to fully re-expand. This negative pressure is a key driver of severe procedural pain, vasovagal symptoms, and premature cessation of drainage. It may also necessitate multiple drainage procedures over a short period.\n\nCurrently, there are limited strategies to mitigate this problem, often relying on stopping the procedure prematurely or on analgesia, which does not address the underlying cause.\n\nThis trial evaluates the introduction of atmospheric air into the pleural space during drainage as a pragmatic, low-cost solution. The technique uses standard equipment - a 3-way tap - allowing air to be introduced safely and intermittently during drainage to reduce the vacuum effect.\n\nPatients undergoing therapeutic pleural drainage with an indwelling catheter or chest drain will be randomised in a 2:1 ratio to:\n\nStandard drainage care (control group)\n\nDrainage with intermittent controlled air introduction (intervention group)\n\nAir entrainment will be performed by briefly opening the 3-way tap to atmospheric air during drainage up to five times, based on patient discomfort and operator discretion. This aims to equalise pleural pressures, reduce pain, and improve drainage outcomes.\n\nRandomisation is weighted 2:1 towards the intervention group to maximise the number of patients who may benefit, following favourable preliminary data. Both patients and outcome assessors will be blinded to group allocation.\n\nOutcomes collected\n\nPrimary Outcomes:\n\nPatient-reported pain scores during drainage - Pain will be assessed using the Visual Analogue Scale (VAS), ranging from 0 to 10 cm, where 0 indicates \"no pain\" and 10 indicates \"worst imaginable pain.\" Higher scores represent a worse outcome.\n\nSecondary Outcomes:\n\nVolume of pleural fluid drained Number of pleural drainage procedures required Time interval between drainage procedures Incidence of complications (e.g., pneumothorax, re-expansion pulmonary oedema, infection) Reasons for incomplete drainage, including the presence and characteristics of non-expandable lung Patient-reported satisfaction with the drainage procedure",[72,73,74,75],"Non-expandable Lung","Trapped Lung","Pleural Effusion","Malignant Pleural Effusions (Mpe)",[77,78,79,80,81],"air entrainment","trapped lung","non-expandable lung (NEL)","pleural effusion","malignant pleural effusion","2025-05-04",{"date":84,"type":85},"2025-05-07","ACTUAL",{"date":87,"type":85},"2025-04-14",{"date":89,"type":66},"2026-10-30",{"name":5,"class":6},1]