Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-30 @ 6:43 PM
Study NCT ID:
NCT06180603
Status:
RECRUITING
Last Update Posted:
2024-12-05
First Post:
2023-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Strategy for Prompt and Effective Thoracentesis in the Emergency Department
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010996', 'term': 'Pleural Effusion'}, {'id': 'D010995', 'term': 'Pleural Diseases'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 188}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-04', 'studyFirstSubmitDate': '2023-11-09', 'studyFirstSubmitQcDate': '2023-12-12', 'lastUpdatePostDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time from identification of the clinical indication for thoracentesis to complete drainage', 'timeFrame': 'From date and time for randomization until the date and time removal of catheter, assessed up to 3 month', 'description': 'Time from identification of the clinical indication for thoracentesis is defined as the time patient is randomized. The time of complete drainage is defined by removal of pigtail catheter'}], 'secondaryOutcomes': [{'measure': 'Hospital length of stay (days)', 'timeFrame': 'Date of admission until date of hospital discharge, assessed up until 3 month', 'description': 'Defined as from date of admission until the date of hospital discharge'}, {'measure': 'Duration of procedure (time)', 'timeFrame': 'from date and time for insertion until date and time for removal, assessed up until 3 month', 'description': 'Defined as from date and time for insertion of catheter until date and time for removal of catheter'}, {'measure': 'Patients degree of chest discomfort (score)', 'timeFrame': 'from date of indication until removal of catheter, assessed up until 3 month', 'description': 'Chest discomfort will be assessed using an appropiate scale before insertion of the catheter, during the procedure and after removal of catheter'}, {'measure': 'Patients degree of breathlessnesss (score)', 'timeFrame': 'from date of indication until removal of catheter, assessed up until 3 month', 'description': 'Breathlessness will be assessed using an appropiate scale before insertion of the catheter, during the procedure and after removal of catheter'}, {'measure': 'Patients satisfaction', 'timeFrame': 'On the date of removal, assessed up until 1 month', 'description': 'After removal of catheter patients will be given a questionnaire'}, {'measure': '72- hour revisit from discharged (count)', 'timeFrame': 'from date of discharge and up until 72 hours', 'description': 'Defined as any unplanned hospital stay within 72 hours from previous hospital discharge'}, {'measure': '30 days re-admission (count)', 'timeFrame': 'from date of discharge and up assessed until 30 days', 'description': 'defined as any admission during 30 day follow-up'}, {'measure': 'Complications to thoracentesis (count)', 'timeFrame': 'from insertion of catheter and assessed up until 1 week after removal of catheter', 'description': 'Number of complications to thoracentesis'}, {'measure': 'Total ED admission time (days)', 'timeFrame': 'From date and time for admission until date and time for ED discharge, assessed up until 1 month', 'description': 'Date and time for admission until date and time for ED discharge'}, {'measure': 'Total volume drained ( ml)', 'timeFrame': 'from date of insertion of catheter until removal of catheter, assessed up until 3 month', 'description': 'the total amount of fluid drained from insertion of catether until removal of cathether'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Thoracentesis', 'Emergency department', 'Treatment methods'], 'conditions': ['Pleural Effusion', 'Pleural Diseases', 'Heart Failure']}, 'descriptionModule': {'briefSummary': 'The SPEEDTAP-trial is a prospective, randomised, investigator-initiated, multicenter, clinical superior trial investigating two thoracentesis methods in four emergency departments (ED) in Central Denmark Region. Patients are randomised to either manual fluid removal in the ED or passively fluid drainage using gravity in the radiology department (standard of care). Primary outcome: time from clinical indication to complete drainage and 188 patients will be included. Key secondary outcomes include length of stay, ED admission to ED discharge and safety end-points.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥ 18 years admitted to the ED\n* Pleural effusion detected by any imaging modality (e.g., bedside ultrasound, chest x-ray, computed tomography)\n* Clinically justified need for thoracentesis ( symptomatic relief and/or define the etiology of the effusion\n* Without contraindication for thoracentesis in the emergency department (e.g., anticoagulant treatment)\n\nExclusion Criteria:\n\n* Life-threatening respiratory distress\n* Not able to give consent\n* Previous pleurodesis\n* Effusion does not appear free-flowing due to septations or loculations / suspected empyema\n* Prior enrollment in the trial\n* If randomization is not possible because decision to insert a pigtail catheter is made in the radiology department'}, 'identificationModule': {'nctId': 'NCT06180603', 'acronym': 'SPEEDTAP', 'briefTitle': 'Strategy for Prompt and Effective Thoracentesis in the Emergency Department', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Strategy for Prompt and Effective Thoracentesis in the Emergency Department: A Multicenter Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'AU307272'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Standard of care thoracentesis in the radiology department ( passively drainage using gravity)', 'interventionNames': ['Procedure: Gravity fluid drainage in the radiology department']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Thoracentesis in the emergency department (manual fluid drainage using a syringe connected to a three-way stopcock)', 'interventionNames': ['Procedure: Manual drainage in the emergency department']}], 'interventions': [{'name': 'Gravity fluid drainage in the radiology department', 'type': 'PROCEDURE', 'description': 'Patients will be referred to the radiology department. Thoracentesis will be performed according to local guidelines.', 'armGroupLabels': ['Control group']}, {'name': 'Manual drainage in the emergency department', 'type': 'PROCEDURE', 'description': 'Thoracentesis will be performed according to current guidelines in the emergency department. Fluid will manually be drained using a syringe connected to a three-way stopcock. Thoracentesis will be stopped early if:', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus', 'state': 'Central Jutland', 'status': 'NOT_YET_RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Nikolaj Raaber, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '7400', 'city': 'Gødstrup', 'state': 'Central Jutland', 'status': 'NOT_YET_RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Larshan Perinpam, MD', 'role': 'CONTACT'}], 'facility': 'Gødstrup Regional Hospital', 'geoPoint': {'lat': 56.15584, 'lon': 8.89276}}, {'zip': '8700', 'city': 'Horsens', 'state': 'Central Jutland', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Malene Christophersen, MD', 'role': 'CONTACT'}], 'facility': 'Horsens Regional Hospital', 'geoPoint': {'lat': 55.86066, 'lon': 9.85034}}, {'zip': '8930', 'city': 'Randers', 'state': 'Central Jutland', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Sandra T Langsted, MD', 'role': 'CONTACT'}], 'facility': 'Randers Regional Hospital', 'geoPoint': {'lat': 56.4607, 'lon': 10.03639}}, {'city': 'Aalborg', 'state': 'North Denmark', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Anne Lund Krarup', 'role': 'CONTACT'}], 'facility': 'Aalborg University Hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'city': 'Esbjerg', 'state': 'South Region Denmark', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Peter Biesenbach, MD,PhD', 'role': 'CONTACT'}], 'facility': 'Esbjerg sygehus', 'geoPoint': {'lat': 55.47028, 'lon': 8.45187}}], 'centralContacts': [{'name': 'Sandra T Langsted', 'role': 'CONTACT', 'email': 'sandra.langsted@clin.au.dk', 'phone': '+45 20 27 65 12'}, {'name': 'Bo Løfgren', 'role': 'CONTACT', 'email': 'bl@clin.au.dk'}], 'overallOfficials': [{'name': 'Sandra T Langsted', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aarhus University Hospital'}]}, 'ipdSharingStatementModule': {'timeFrame': 'Six months after the publication of the last results, all de-identified individual patient data will be made available upon request. There will be no predetermined end date for the data sharing.', 'ipdSharing': 'YES', 'description': 'De-identified data necessary to reproduce published results will be made available on reasonable requests.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Central Denmark Region', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}