[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100570608":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":39,"responsibleParty":127,"collaborators":131,"id":134,"slug":135,"hasResults":136,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":18,"eligibilityCriteria":140,"healthyVolunteers":136,"sex":141,"minAge":142,"maxAge":18,"enrollmentInfo":143,"targetDuration":18,"studyType":146,"phases":147,"briefSummary":149,"conditions":150,"keywords":153,"overallStatus":42,"whyStopped":18,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":172},{"fullName":5,"class":6},"Aalborg University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Pleural drainage","EXPERIMENTAL","Ultrasonography-guided pleural drainage with insertion of a small-bore intrapleural catheter (typically pig-tail type catheter, size 6-14 French), conducted by e.g., intensivists or radiologists, as by local standards, of the pleural cavity with the estimated largest pleural effusion as soon as possible. A time interval of up to 24 hours from randomisation to intervention is expected. If bilateral pleural effusions ≥ 2 cm are present at randomisation, drainage of contralateral pleura should be conducted as soon as possible according to local standards, at least within 24 hours from insertion of the first pleural catheter unless pleural effusion has receded to \\\u003C 2 cm prior to drainage. Inserted pleural catheters remain connected to a closed pleural drainage system, in situ and open until removed at clinicians' discretion according to local standards. New pleural effusion ≥ 2 cm during ICU stay within 90 days from randomisation will be drained similarly.",[13],"Procedure: Ultrasonography-guided pleural drainage",{"label":15,"type":16,"description":17,"interventionNames":18},"No pleural drainage","NO_INTERVENTION","No pleural drainage is conducted during ICU stay in 90 days from randomisation, unless escape protocol criteria are present being suspected or confirmed haemothorax, suspected or confirmed pneumothorax, suspected or confirmed pleural empyema, suspected or confirmed pleural malignancy, or indication for therapeutic pleural drainage as per the treating clinician and invasive or non-invasive mechanical ventilation or mask CPAP with arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2\u002FFiO2) ratio ≤ 13.3 kPa in the most recent ABG analysis, high-flow humidified oxygen therapy with a flow ≥ 50 L\u002Fmin and a PaO2\u002FFiO2 ratio ≤ 13.3 kPa in the most recent ABG analysis, or persistent respiratory acidosis with a pH \\\u003C 7.25 and an arterial partial pressure of carbon dioxide (PaCO2) \\> 6.0 kPa on the most recent ABG analysis in spite of non-invasive ventilation for \\> 1 hour.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"PROCEDURE","Ultrasonography-guided pleural drainage","Ultrasonography-guided pleural drainage with insertion of a small-bore intrapleural catheter. Contralateral and repeated drainage conducted as specified during ICU stay until day 90.",[9],[26],{"name":27,"affiliation":28,"role":29},"Olav L Schjørring, MD, PhD","Department of Anaesthesia and Intensive Care, Aalborg University Hospital, Denmark","PRINCIPAL_INVESTIGATOR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},"Marie S Worm, MD","CONTACT","+45 97 66 19 24","marie.worm@rn.dk",{"name":27,"role":33,"phone":37,"phoneExt":18,"email":38},"+45 97 66 19 21","o.schjoerring@rn.dk",[40,56,70,84,98,113],{"facility":41,"status":42,"city":43,"state":18,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Department of Anaesthesia and Intensive Care, Aalborg University Hospital","RECRUITING","Aalborg","9000","Denmark","DK",{"type":48,"coordinates":49},"Point",[50,51],9.9187,57.048,{"lat":51,"lon":50},[54,55],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},{"name":27,"role":33,"phone":37,"phoneExt":18,"email":38},{"facility":57,"status":42,"city":58,"state":18,"zip":59,"country":45,"countryCode":46,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"ICU department 4131, Copenhagen University Hospital, Rigshospitalet","Copenhagen","2100",{"type":48,"coordinates":61},[62,63],12.56553,55.67594,{"lat":63,"lon":62},[66],{"name":67,"role":33,"phone":68,"phoneExt":18,"email":69},"Morten H Møller, MD, PhD","+45 35 45 86 85","morten.hylander.moeller@regionh.dk",{"facility":71,"status":42,"city":72,"state":18,"zip":73,"country":45,"countryCode":46,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Department of Anaesthesia and Intensive Care, Nordsjællands Hospital, University of Copenhagen, Hillerød","Hillerød","3400",{"type":48,"coordinates":75},[76,77],12.30081,55.92791,{"lat":77,"lon":76},[80],{"name":81,"role":33,"phone":82,"phoneExt":18,"email":83},"Morten H Bestle, MD, PhD","+45 48 29 20 17","morten.bestle@regionh.dk",{"facility":85,"status":42,"city":86,"state":18,"zip":87,"country":45,"countryCode":46,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"Department of Anaesthesiology and Intensive Care Medicine, Sygehus Lillebælt, Kolding","Kolding","6000",{"type":48,"coordinates":89},[90,91],9.47216,55.4904,{"lat":91,"lon":90},[94],{"name":95,"role":33,"phone":96,"phoneExt":18,"email":97},"Anne C Brøchner, MD, PhD","+45 76 36 31 14","anne.craveiro.broechner@rsyd.dk",{"facility":99,"status":100,"city":101,"state":18,"zip":102,"country":45,"countryCode":46,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"Department of Anaesthesia and Intensive Care, Zealand University Hospital, Køge","NOT_YET_RECRUITING","Køge","4600",{"type":48,"coordinates":104},[105,106],12.18214,55.45802,{"lat":106,"lon":105},[109],{"name":110,"role":33,"phone":111,"phoneExt":18,"email":112},"Lars PK Andersen, MD, PhD","+45 56 63 15 00","lapan@regionsjaelland.dk",{"facility":114,"status":100,"city":115,"state":18,"zip":116,"country":45,"countryCode":46,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"Department of Anaesthesia and Intensive Care, Zealand University Hospital, Roskilde","Roskilde","4000",{"type":48,"coordinates":118},[119,120],12.08035,55.64152,{"lat":120,"lon":119},[123],{"name":124,"role":33,"phone":125,"phoneExt":18,"email":126},"Henrik P Pedersen, MD","+45 46 32 32 00","hppd@regionsjaelland.dk",{"type":128,"investigatorFullName":129,"investigatorTitle":130,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"SPONSOR_INVESTIGATOR","Olav Schjørring","Associate Professor, Consultant, MD, PhD",[132],{"name":133,"class":6},"Rigshospitalet, Denmark","100570608","drainage-of-pleural-effusions-in-the-intensive-care-unit-dope-icu---feasibility-trial-100570608",false,"NCT06709456","Drainage Of Pleural Effusions in the Intensive Care Unit (DOPE-ICU) - Feasibility Trial","Drainage of Pleural Effusions in the Intensive Care Unit in Adults With Respiratory Failure: A Randomised Clinical Feasibility Trial of Performing Versus Withholding Pleural Drainage","Inclusion Criteria:\n\n* Acute admission to the ICU.\n* Age ≥ 18 years.\n* Pleural effusion ≥ 2 cm in either pleural cavity assessed by ultrasonography, computed tomography or magnetic resonance imaging (measured between the parietal and visceral pleura perpendicularly to the chest wall at the largest-separation point).\n* Respiratory failure defined as one or more of the following: any oxygen supplementation in an open system, invasive or non-invasive mechanical ventilation (including non-intermittent mask CPAP), or most recent arterial blood gas analysis with arterial partial pressure of carbon dioxide (PaCO2) \\> 6.0 kPa and pH \\\u003C 7.35.\n\nExclusion Criteria:\n\n* Mediastinal drain or pleural drain in situ on either side.\n* Suspected or confirmed haemothorax (e.g., due to recent thoracic trauma or intrathoracic surgery).\n* Suspected or confirmed pneumothorax (e.g., by anamnesis, on radiographic or ultrasonographic assessment, or by clinical presentation, e.g., due to presence of subcutaneous emphysema).\n* Suspected or confirmed pleural empyema (e.g., by anamnesis or clinical presentation, or on CT, MRI or ultrasonographic assessment).\n* Pleural malignancy (suspected or confirmed pleural lymphoma, pleural metastases or direct pleural invasion, or malignant mesothelioma).\n* Antithrombotic treatment or coagulation deficiency incompatible with conducting pleural drainage as by local recommendations, and contraindications to reversal of this (clinical assessment).\n* Clinically assessed absolute indication for therapeutic pleural drainage and:\n\n  * invasive or non-invasive mechanical ventilation or mask CPAP with PaO2\u002FFiO2 ratio ≤ 13.3 kPa in the most recent ABG analysis.\n  * high-flow humidified oxygen therapy with a flow ≥ 50 L\u002Fmin and a PaO2\u002FFiO2 ratio ≤ 13.3 kPa in the most recent ABG analysis.\n  * persistent respiratory acidosis with a pH \\\u003C 7.25 and a PaCO2 \\> 6.0 kPa in the most recent ABG analysis in spite of non-invasive ventilation for \\> 1 hour.\n* Withdrawal from active therapy or brain death deemed imminent.\n* Expected ICU stay \\\u003C 24 hours from randomisation.\n* Pregnancy (in females \\\u003C 60 years of age, non-pregnancy must be confirmed by a negative urine or plasma human chorionic gonadotropin, or presence a condition incompatible with pregnancy, e.g., previous hysterectomy, or conducted caesarean section during current hospitalisation).\n* Under coercive measures (i.e., ongoing involuntary hospital admission or under correctional authorities' jurisdiction).\n* Consent not obtainable as per Danish legislation.\n* Previously randomised in the DOPE-ICU feasibility trial.","ALL","18 Years",{"count":144,"type":145},88,"ESTIMATED","INTERVENTIONAL",[148],"NA","This trial evaluates the feasibility of ultrasound-guided pleural drainage versus no drainage in adult ICU patients with pleural effusions (fluid buildup around the lungs) and respiratory failure. Half of the patients will undergo drainage, while the other half will not unless their condition worsens to a prespecified degree. Outcomes include feasibility measures, clinical parameters, mortality, serious adverse events, and life support use over 90 days.",[151,152],"Pleural Effusions","Respiratory Failure",[154,155,9,156,157,158,159,160,161,162],"Pleural effusion","Respiratory failure","Ultrasonography","Intensive Care Unit","Randomised clinical trial","Feasibility","Critical care","Hypoxaemia","Hypercapnia","2025-04-09",{"date":165,"type":166},"2025-04-11","ACTUAL",{"date":168,"type":166},"2024-12-02",{"date":170,"type":145},"2025-10",{"name":129,"class":6},6]