Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-29 @ 5:45 PM
Study NCT ID:
NCT01775657
Status:
COMPLETED
Last Update Posted:
2022-11-21
First Post:
2012-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Digital Versus Analog Pleural Drainage Following Pulmonary Resection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 176}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-18', 'studyFirstSubmitDate': '2012-11-29', 'studyFirstSubmitQcDate': '2013-01-24', 'lastUpdatePostDateStruct': {'date': '2022-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall length of hospitalization', 'timeFrame': 'Up to 5 days post-op (average)'}], 'secondaryOutcomes': [{'measure': 'Time to first pleural drain removal', 'timeFrame': 'Over 24 hours post-op'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pulmonary air leak', 'Thopaz', 'digital', 'analog', 'randomized'], 'conditions': ['Pulmonary Air Leak', 'Lobectomy', 'Wedge Resection', 'Segmentectomy']}, 'referencesModule': {'references': [{'pmid': '26409729', 'type': 'DERIVED', 'citation': 'Gilbert S, McGuire AL, Maghera S, Sundaresan SR, Seely AJ, Maziak DE, Shamji FM, Villeneuve PJ. Randomized trial of digital versus analog pleural drainage in patients with or without a pulmonary air leak after lung resection. J Thorac Cardiovasc Surg. 2015 Nov;150(5):1243-9. doi: 10.1016/j.jtcvs.2015.08.051. Epub 2015 Aug 28.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the impact of continuous, digital pulmonary air leak monitoring on the duration of pleural drainage after lung resection in patients with and without a pulmonary air leak on postoperative day 1.\n\nPatients undergoing pulmonary resection who fit the inclusion criteria will be identified pre-operatively. Patients within two groups (air leak and no air leak) will be randomized to receive either the analogue system or the digital system. Both systems are approved for use in hospitals by Health Canada. There will be 88 patients in each air leak group.\n\nHypothesis: Continuous, quantitative monitoring of PAL following lung resection leads to an improvement in primary outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nElective pulmonary resection (i.e. wedge, segmentectomy, lobectomy, bilobectomy) for benign or neoplastic disease\n\nExclusion Criteria:\n\n1. Development of tension pneumothorax\n2. Pneumonectomy\n3. Patient no longer within planned randomization window\n4. Plan to remove or removal of all chest drains within 36 hours of surgery\n5. Inability to provide informed consent\n6. Age \\< 18 years\n7. Patient was previously randomized following pulmonary resection'}, 'identificationModule': {'nctId': 'NCT01775657', 'acronym': 'DiVA Phase II', 'briefTitle': 'Digital Versus Analog Pleural Drainage Following Pulmonary Resection', 'organization': {'class': 'OTHER', 'fullName': 'Ottawa Hospital Research Institute'}, 'officialTitle': 'Digital Versus Analog Pleural Drainage Following Pulmonary Resection', 'orgStudyIdInfo': {'id': '20120228-01H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Air leak present - Analogue', 'description': 'Patients randomized to Pleur Evac (Analogue drainage) monitoring system, air leak present.', 'interventionNames': ['Device: Pleur Evac (Analogue drainage)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Air leak absent - Analogue (Pleur Evac)', 'description': 'Patients randomized to Pleur Evac (Analogue drainage) monitoring system, no air leak present', 'interventionNames': ['Device: Pleur Evac (Analogue drainage)']}, {'type': 'EXPERIMENTAL', 'label': 'Air leak present - Digital (Thopaz)', 'description': 'Patients with an air leak present, randomized to Thopaz (digital drainage) monitoring system.', 'interventionNames': ['Device: Thopaz (Digital drainage)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Air leak absent - Digital (Thopaz)', 'description': 'Patients randomized to digital system, no air leak present.', 'interventionNames': ['Device: Thopaz (Digital drainage)']}], 'interventions': [{'name': 'Thopaz (Digital drainage)', 'type': 'DEVICE', 'otherNames': ['Thopaz, Medela Switzerland'], 'armGroupLabels': ['Air leak absent - Digital (Thopaz)', 'Air leak present - Digital (Thopaz)']}, {'name': 'Pleur Evac (Analogue drainage)', 'type': 'DEVICE', 'otherNames': ['Pleur Evac A-6002-08, Teleflex Inc, Research Triangle Park, NC, USA'], 'armGroupLabels': ['Air leak absent - Analogue (Pleur Evac)', 'Air leak present - Analogue']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K1H8L6', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Ottawa Hospital, General Campus', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'overallOfficials': [{'name': 'Sebastien Gilbert, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ottawa Hospital Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ottawa Hospital Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}