Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2026-02-28 @ 10:56 PM
Study NCT ID:
NCT03486002
Status:
TERMINATED
Last Update Posted:
2020-09-23
First Post:
2018-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EFFEXTS OF THE CLEANSWEEP SUCTION CATHETER
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': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'whyStopped': 'Access to the devices was halted by the sponsor', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-07-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2020-04-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-21', 'studyFirstSubmitDate': '2018-03-27', 'studyFirstSubmitQcDate': '2018-03-27', 'lastUpdatePostDateStruct': {'date': '2020-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in endotracheal tube resistance during mechanical ventilation after 4 suction procedures', 'timeFrame': '8 hours', 'description': 'Measurements of resistance will be made following each suction procedure (2 with the Cleansweep system and 2 with the standard system)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endotracheal Tube Clearance']}, 'descriptionModule': {'briefSummary': 'This study is designed to compare the effectiveness of a closed suction system with an inflatable balloon on the catheter (Cleansweep system) to that of a standard closed suction system in terms of reducing the interior resistance of endotracheal tubes. Subjects who require frequent suctioning ( \\> every 2.5 hours) and who have stable cardiovascular systems will be randomized to receive suctioning either through the Cleansweep system or standard system initially followed by the corresponding system. The subjects will be suctioned every two hours for eight hours ( the first 2 suction procedures with one system followed by 2 with the other system). After each suction procedure measurements of resistance will be made using peak and plateau pressures.\n\nAnalysis: For each patient, data for both procedures on each catheter system will be pooled and mean differences between the standard system and the Cleansweep system will be calculated. For all 20 patients the mean (+/- SD) of these differences will be calculated and significance will be sought using appropriate statistical tests. The study will be unblinded and randomization determines merely which system will used initially for the first 2 procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Intubated, mechanically ventilated patients who require suctioning more often than every 2.5 hours\n\nExclusion Criteria:\n\n* Unstable cardiovascular system (significant arrythmias, blood pressure support requiring \\> 2 pressors\n* refractory hypoxemia (P/F ratio \\< 80)'}, 'identificationModule': {'nctId': 'NCT03486002', 'briefTitle': 'EFFEXTS OF THE CLEANSWEEP SUCTION CATHETER', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'EFFECTS OF TELEFLEX CATHETER (CLEANSWEEP) ON VENTILATOR MECHANICS', 'orgStudyIdInfo': {'id': 'Pro00087066'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Cleansweep closed suction system', 'interventionNames': ['Device: Cleansweep']}, {'type': 'OTHER', 'label': 'Halyard closed suction system', 'interventionNames': ['Device: Halyard']}], 'interventions': [{'name': 'Cleansweep', 'type': 'DEVICE', 'description': 'The Cleansweep closed suction system', 'armGroupLabels': ['Cleansweep closed suction system']}, {'name': 'Halyard', 'type': 'DEVICE', 'description': 'Halyard Closed Suction System', 'armGroupLabels': ['Halyard closed suction system']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Health System', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Neil MacIntyre', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Teleflex', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}