Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2026-01-03 @ 10:24 PM
Study NCT ID:
NCT03868735
Status:
COMPLETED
Last Update Posted:
2023-03-23
First Post:
2019-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of the CleanSweep™ Closed Suction System on Length of Mechanical Ventilation and Ventilator-Associated Events
Sponsor:
Organization:
Raw JSON
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Brady Scott', 'organization': 'Rush University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '2 years', 'eventGroups': [{'id': 'EG000', 'title': 'CleanSweep Closed Suction System', 'description': 'Device that includes balloon sweeping technology\n\nCleanSweep Closed Suction System: Device with balloon sweeping technology', 'otherNumAtRisk': 136, 'deathsNumAtRisk': 136, 'otherNumAffected': 0, 'seriousNumAtRisk': 136, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard In-line Suction Device', 'description': 'In-line suction device already in on intubated patients with an endotracheal tube', 'otherNumAtRisk': 136, 'deathsNumAtRisk': 136, 'otherNumAffected': 0, 'seriousNumAtRisk': 136, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Length of Time on a Mechanical Ventilator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CleanSweep Closed Suction System', 'description': 'Device that includes balloon sweeping technology\n\nCleanSweep Closed Suction System: Device with balloon sweeping technology'}, {'id': 'OG001', 'title': 'Standard In-line Suction Device', 'description': 'In-line suction device already in on intubated patients with an endotracheal tube'}], 'classes': [{'categories': [{'measurements': [{'value': '70.6', 'groupId': 'OG000', 'lowerLimit': '37', 'upperLimit': '148'}, {'value': '72.2', 'groupId': 'OG001', 'lowerLimit': '37', 'upperLimit': '187'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Hospital admission to discharge (up to about 20 days)', 'description': 'Length of time on mechanical ventilation was recorded in hours.', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to First Successful Spontaneous Breathing Trial (SBT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CleanSweep Closed Suction System', 'description': 'Device that includes balloon sweeping technology\n\nCleanSweep Closed Suction System: Device with balloon sweeping technology'}, {'id': 'OG001', 'title': 'Standard In-line Suction Device', 'description': 'In-line suction device already in on intubated patients with an endotracheal tube'}], 'classes': [{'categories': [{'measurements': [{'value': '45.7', 'groupId': 'OG000', 'lowerLimit': '27', 'upperLimit': '95'}, {'value': '46.7', 'groupId': 'OG001', 'lowerLimit': '30', 'upperLimit': '87'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Hospital admission to discharge (up to about 20 days)', 'description': 'Time to first successful SBT in mechanically ventilated patients in the medical intensive care unit.', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Time in the Intensive Care Unit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CleanSweep Closed Suction System', 'description': 'Device that includes balloon sweeping technology\n\nCleanSweep Closed Suction System: Device with balloon sweeping technology'}, {'id': 'OG001', 'title': 'Standard In-line Suction Device', 'description': 'In-line suction device already in on intubated patients with an endotracheal tube'}], 'classes': [{'categories': [{'measurements': [{'value': '7.8', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '18'}, {'value': '9', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '20'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Hospital admission to discharge (up to about 20 days)', 'description': 'Length of time spent in the intensive care units in days', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Total Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CleanSweep Closed Suction System', 'description': 'Device that includes balloon sweeping technology\n\nCleanSweep Closed Suction System: Device with balloon sweeping technology'}, {'id': 'OG001', 'title': 'Standard In-line Suction Device', 'description': 'In-line suction device already in on intubated patients with an endotracheal tube'}], 'classes': [{'categories': [{'measurements': [{'value': '13.9', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '25'}, {'value': '14.7', 'groupId': 'OG001', 'lowerLimit': '8', 'upperLimit': '26'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Hospital admission to discharge (up to about 20 days)', 'description': 'Length of total time spent in the hospital in days', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Ventilator-associated Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CleanSweep Closed Suction System', 'description': 'Device that includes balloon sweeping technology\n\nCleanSweep Closed Suction System: Device with balloon sweeping technology'}, {'id': 'OG001', 'title': 'Standard In-line Suction Device', 'description': 'In-line suction device already in on intubated patients with an endotracheal tube'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Hospital admission to discharge (up to about 20 days)', 'description': 'Number of Participants with ventilator-associated events, like pneumonia', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CleanSweep Closed Suction System', 'description': 'Device that includes balloon sweeping technology\n\nCleanSweep Closed Suction System: Device with balloon sweeping technology'}, {'id': 'FG001', 'title': 'Standard In-line Suction Device', 'description': 'In-line suction device already in on intubated patients with an endotracheal tube'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '136'}, {'groupId': 'FG001', 'numSubjects': '136'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '136'}, {'groupId': 'FG001', 'numSubjects': '136'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'BG000'}, {'value': '136', 'groupId': 'BG001'}, {'value': '272', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CleanSweep Closed Suction System', 'description': 'Device that includes balloon sweeping technology\n\nCleanSweep Closed Suction System: Device with balloon sweeping technology'}, {'id': 'BG001', 'title': 'Standard In-line Suction Device', 'description': 'In-line suction device already in on intubated patients with an endotracheal tube'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000', 'lowerLimit': '52', 'upperLimit': '72'}, {'value': '63', 'groupId': 'BG001', 'lowerLimit': '52', 'upperLimit': '74'}, {'value': '63', 'groupId': 'BG002', 'lowerLimit': '52', 'upperLimit': '73'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African American', 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}]}, {'title': 'Caucasian', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '136', 'groupId': 'BG000'}, {'value': '136', 'groupId': 'BG001'}, {'value': '272', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '28.8', 'groupId': 'BG000', 'lowerLimit': '24', 'upperLimit': '34'}, {'value': '29.3', 'groupId': 'BG001', 'lowerLimit': '25', 'upperLimit': '35'}, {'value': '29.05', 'groupId': 'BG002', 'lowerLimit': '24.5', 'upperLimit': '34.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-05-15', 'size': 270794, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-03-14T12:29', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 272}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-21', 'studyFirstSubmitDate': '2019-03-05', 'resultsFirstSubmitDate': '2023-02-13', 'studyFirstSubmitQcDate': '2019-03-06', 'lastUpdatePostDateStruct': {'date': '2023-03-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-03-14', 'studyFirstPostDateStruct': {'date': '2019-03-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of Time on a Mechanical Ventilator', 'timeFrame': 'Hospital admission to discharge (up to about 20 days)', 'description': 'Length of time on mechanical ventilation was recorded in hours.'}], 'secondaryOutcomes': [{'measure': 'Time to First Successful Spontaneous Breathing Trial (SBT)', 'timeFrame': 'Hospital admission to discharge (up to about 20 days)', 'description': 'Time to first successful SBT in mechanically ventilated patients in the medical intensive care unit.'}, {'measure': 'Length of Time in the Intensive Care Unit', 'timeFrame': 'Hospital admission to discharge (up to about 20 days)', 'description': 'Length of time spent in the intensive care units in days'}, {'measure': 'Length of Total Hospital Stay', 'timeFrame': 'Hospital admission to discharge (up to about 20 days)', 'description': 'Length of total time spent in the hospital in days'}, {'measure': 'Number of Participants With Ventilator-associated Events', 'timeFrame': 'Hospital admission to discharge (up to about 20 days)', 'description': 'Number of Participants with ventilator-associated events, like pneumonia'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Mechanical Ventilation Complication']}, 'descriptionModule': {'briefSummary': 'The primary aim of this study is to evaluate the CleanSweep™ Closed Suction System on time to first successful spontaneous breathing trial in mechanically ventilated patients in the medical intensive care unit. Secondary aims of this study are to evaluate the use endotracheal tube sweeping compared to closed suctioning effect on length of mechanical ventilation, length of ICU stay, length of total hospital stay, and occurrence of ventilator-associated events.', 'detailedDescription': 'This is designed as a prospective, randomized control trial, in a large, urban, academic medical center. This study will include mechanically ventilated patients (n = 272) in the medical intensive care unit (MICU) at Rush University Medical Center. It will exclude patients with a tracheostomy on admission, those requiring extracorporeal membrane oxygenation (ECMO), or transferred from an outside facility receiving more than 24 hours of mechanical ventilation. Two groups will be randomly assigned via computer randomization. The experimental group will be placed on the CleanSweep™ Closed Suction System immediately after intubation or upon arrival to the MICU. Endotracheal tubes (ETTs) will be cleaned with the balloon sweeping technology every time a respiratory therapist suctions the patient. The control group will be placed on the standard in-line suction device. Airway suctioning will be performed in both groups as per department policy (Catheter advanced until resistance is met and withdrawn slowly for a duration no longer than 15 seconds while applying negative pressure). Both groups will also receive a ventilator bundle that consists of head of bed elevation, ETT cuff pressure management, deep vein thrombosis prevention, daily sedation interruption and SBT, and oral care every 4 hours with chlorhexidine at 12pm (noon) and 12am midnight.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Orally intubated patient with endotracheal tube\n* Mechanically ventilated less than 24 hours prior to enrollment\n\nExclusion Criteria:\n\n* Less than 18 years old\n* Tracheostomy tube\n* Extracorporeal membrane oxygenation\n* Transfer from outside hospital with more than 24 hours of mechanical ventilation'}, 'identificationModule': {'nctId': 'NCT03868735', 'briefTitle': 'Evaluation of the CleanSweep™ Closed Suction System on Length of Mechanical Ventilation and Ventilator-Associated Events', 'organization': {'class': 'OTHER', 'fullName': 'Rush University Medical Center'}, 'officialTitle': 'Evaluation of the CleanSweep™ Closed Suction System on Length of Mechanical Ventilation and Ventilator-Associated Events', 'orgStudyIdInfo': {'id': '18110802'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CleanSweep Closed Suction System', 'description': 'Device that includes balloon sweeping technology', 'interventionNames': ['Device: CleanSweep Closed Suction System']}, {'type': 'NO_INTERVENTION', 'label': 'Standard in-line suction device', 'description': 'In-line suction device already in on intubated patients with an endotracheal tube'}], 'interventions': [{'name': 'CleanSweep Closed Suction System', 'type': 'DEVICE', 'description': 'Device with balloon sweeping technology', 'armGroupLabels': ['CleanSweep Closed Suction System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60187', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Jonathan B Scott, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rush University University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rush University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}