Ignite Creation Date:
2025-12-24 @ 9:29 PM
Ignite Modification Date:
2025-12-25 @ 7:14 PM
Study NCT ID:
NCT01566032
Status:
COMPLETED
Last Update Posted:
2017-07-07
First Post:
2012-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Digital Versus Analog Pleural Drainage in Patients With Pulmonary Air Leak
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-05', 'studyFirstSubmitDate': '2012-03-26', 'studyFirstSubmitQcDate': '2012-03-28', 'lastUpdatePostDateStruct': {'date': '2017-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-03-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inter-rater variability of air leak measurements.', 'timeFrame': 'Post-op', 'description': 'Time frame will occur once patients have experienced an air leak. 70% of patients are expected to have a PAL on postoperative day 1. There will be a 4 hour window to complete observations from the numerical device. These observations will be followed by observations on digital device. Each observer should spend 5-10 min to complete both tasks.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pulmonary air leak', 'Thopaz', 'analog', 'digital'], 'conditions': ['Pulmonary Air Leak']}, 'descriptionModule': {'briefSummary': 'The amount of air leaking from a chest tube can be measured in two main ways:\n\n1. electronic monitor connected to the chest tube\n2. numerical (non-electronic) monitor connected to the chest tube\n\nFor people who have had lung surgery, it is important to understand the impact of measuring air leaks accurately in both the short term and the long term. An electronic medical device called Thopaz measures air leak electronically. Another medical device called Pleur-evac measures air leak numerically. The purpose of this study is to understand the accuracy of the method used by doctors and nurses to determine if a chest tube has an air leak. It is also important to determine the size or severity of an air leak.', 'detailedDescription': 'Patients with air leaks following lung surgery will be assessed by a target number of 6 observers each (three nurses and three MDs) who will be randomly asked to participate. Patients will first be connected to the numerical air leak detector, followed by the electronic air leak detector. Observers will record their responses for each device. They will be blinded to responses from other observers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A target of 30 patients at the Ottawa Hospital who experienced pulmonary air leak following pulmonary resection will be recruited.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or over\n* Male and Female.\n* Air leak occuring after any pulmonary resection\n* Air leak persisting on or after the first post-op day of pleural drainage\n* Air leak not entirely secondary to poor air seal at the pleural drainage incision site\n* Pulmonary resection for benign or neoplastic diagnosis\n\nExclusion Criteria:\n\n* Tension pneumothorax\n* Traumatic or iatrogenic pneumothorax\n* Primary or recurrent spontaneous pneumothorax awaiting surgery\n* Pneumonectomy patient (history of or current)'}, 'identificationModule': {'nctId': 'NCT01566032', 'acronym': 'DiVA', 'briefTitle': 'Digital Versus Analog Pleural Drainage in Patients With Pulmonary Air Leak', 'organization': {'class': 'OTHER', 'fullName': 'Ottawa Hospital Research Institute'}, 'officialTitle': 'Digital Versus Analog Pleural Drainage in Patients With Pulmonary Air Leak', 'orgStudyIdInfo': {'id': '2011619-01H'}}, 'contactsLocationsModule': {'locations': [{'zip': 'K1H 8L6', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Ottawa General Hospital', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'overallOfficials': [{'name': 'Sebastien Gilbert, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ottawa Hospital/Ottawa Hospital Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ottawa Hospital Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}