Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-02-22 @ 9:52 AM
Study NCT ID:
NCT05424120
Status:
COMPLETED
Last Update Posted:
2023-11-07
First Post:
2022-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thoracentesis QI Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010996', 'term': 'Pleural Effusion'}], 'ancestors': [{'id': 'D010995', 'term': 'Pleural Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a randomized controlled, non-blinded, single-center, quality improvement study to determine which method of standard of care thoracentesis (wall suctioning, manual aspiration, or vacuum drainage) has the shortest procedural time.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-03', 'studyFirstSubmitDate': '2022-04-25', 'studyFirstSubmitQcDate': '2022-06-14', 'lastUpdatePostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Procedural time to 500mL', 'timeFrame': 'Through study completion, an average of 24 hours', 'description': 'Time to pleural fluid drainage from initiation of therapeutic drainage to 500mL'}, {'measure': 'Procedural time to 750mL', 'timeFrame': 'Through study completion, an average of 24 hours', 'description': 'Time to pleural fluid drainage from initiation of therapeutic drainage to 750mL'}, {'measure': 'Procedural time to 1L', 'timeFrame': 'Through study completion, an average of 24 hours', 'description': 'Time to pleural fluid drainage from initiation of therapeutic drainage to 1L'}, {'measure': 'Pain and dyspnea scores- Baseline', 'timeFrame': 'Immediately prior to starting the thoracentesis', 'description': 'Patients will be asked to indicate their pain and dyspnea level verbally using the Modified Borg Scale for Dyspnea and Numerical Ratings Scale (0-10, with 10 being highest level of pain)'}, {'measure': 'Pain and dyspnea scores- Cath', 'timeFrame': 'Through study completion, an average of 24 hours', 'description': 'Patients will be asked to indicate their pain and dyspnea level verbally using the Modified Borg Scale for Dyspnea and Numerical Ratings Scale (0-10, with 10 being highest level of pain)'}, {'measure': 'Pain and dyspnea scores- Post-fluid', 'timeFrame': 'Through study completion, an average of 24 hours', 'description': 'Patients will be asked to indicate their pain and dyspnea level verbally using the Modified Borg Scale for Dyspnea and Numerical Ratings Scale (0-10, with 10 being highest level of pain)'}, {'measure': 'Pain and dyspnea scores- Post-cath', 'timeFrame': 'Immediately after removing the thoracentesis catheter', 'description': 'Patients will be asked to indicate their pain and dyspnea level verbally using the Modified Borg Scale for Dyspnea and Numerical Ratings Scale (0-10, with 10 being highest level of pain)'}, {'measure': 'Pain and dyspnea scores- 5m post', 'timeFrame': '5 minutes post-procedure', 'description': 'Patients will be asked to indicate their pain and dyspnea level verbally using the Modified Borg Scale for Dyspnea and Numerical Ratings Scale (0-10, with 10 being highest level of pain)'}, {'measure': 'Pain and dyspnea scores- 24h post', 'timeFrame': '24 hours post-procedure', 'description': 'Patients will be asked to indicate their pain and dyspnea level verbally using the Modified Borg Scale for Dyspnea and Numerical Ratings Scale (0-10, with 10 being highest level of pain)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pleural effusion', 'thoracentesis', 'wall suction', 'manual aspiration', 'vacuum bottle drainage'], 'conditions': ['Pleural Effusion']}, 'descriptionModule': {'briefSummary': 'Researchers will compare 3 standard of care methods of pleural fluid drainage during therapeutic thoracentesis. Patients are randomized to manual aspiration, vacuum bottle drainage or wall suction methods. Primary outcome is procedural time with secondary outcomes of pain and dyspnea scores.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18\n* Evidence of pleural effusion on imaging\n* Clinical indication for thoracentesis\n\nExclusion Criteria:\n\n* Age \\<18\n* Standard contraindication for thoracentesis procedure\n* Patients on positive pressure ventilation\n* Patients who have opted out of research in EPIC'}, 'identificationModule': {'nctId': 'NCT05424120', 'briefTitle': 'Thoracentesis QI Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Thoracentesis Quality Improvement (QI) Study', 'orgStudyIdInfo': {'id': 'PACCS-2021-30297'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Manual aspiration', 'description': 'pleural fluid is drained using a standard thoracentesis kit and via a syringe and three-way stopcock', 'interventionNames': ['Procedure: Manual aspiration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Wall suction', 'description': 'pleural fluid is drained using a standard thoracentesis kit and by attaching tubing to wall suctioning set at -50 mmHg continuously', 'interventionNames': ['Procedure: Wall suction']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vacuum bottle drainage', 'description': 'pleural fluid is drained using a standard thoracentesis kit and tubing that attaches to a glass vacuum container', 'interventionNames': ['Procedure: Vacuum bottle drainage']}], 'interventions': [{'name': 'Manual aspiration', 'type': 'PROCEDURE', 'description': 'One option from standard of care', 'armGroupLabels': ['Manual aspiration']}, {'name': 'Wall suction', 'type': 'PROCEDURE', 'description': 'One option from standard of care', 'armGroupLabels': ['Wall suction']}, {'name': 'Vacuum bottle drainage', 'type': 'PROCEDURE', 'description': 'One option from standard of care', 'armGroupLabels': ['Vacuum bottle drainage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Roy Cho, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}