Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:03 AM
Study NCT ID:
NCT01912105
Status:
COMPLETED
Last Update Posted:
2015-08-25
First Post:
2013-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of a Closed Suction System to Remove Secretions From the Endotracheal Tube
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-24', 'studyFirstSubmitDate': '2013-06-10', 'studyFirstSubmitQcDate': '2013-07-29', 'lastUpdatePostDateStruct': {'date': '2015-08-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'endotracheal tube colonization', 'timeFrame': 'within 48 hours after extubation', 'description': 'assessed by microbiologic testing of the endotracheal tube lavage fluid'}], 'primaryOutcomes': [{'measure': 'Volume of secretions', 'timeFrame': 'within 12 hours after extubation', 'description': 'Volume of secretions retained inside the endotracheal tube, assessed by micro ct scan'}], 'secondaryOutcomes': [{'measure': 'adverse events', 'timeFrame': 'until extubation, death or tracheostomy (approximately 2 weeks)', 'description': 'report of major and minor adverse events related to the use of the device'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['endotracheal tube', 'ct scan', 'cleaning device', 'biofilm', 'mechanical ventilation'], 'conditions': ['Intubation', 'Expected Duration of Ventilation > 48h']}, 'referencesModule': {'references': [{'pmid': '21926595', 'type': 'BACKGROUND', 'citation': 'Berra L, Coppadoro A, Bittner EA, Kolobow T, Laquerriere P, Pohlmann JR, Bramati S, Moss J, Pesenti A. A clinical assessment of the Mucus Shaver: a device to keep the endotracheal tube free from secretions. Crit Care Med. 2012 Jan;40(1):119-24. doi: 10.1097/CCM.0b013e31822e9fe3.'}, {'pmid': '26714807', 'type': 'DERIVED', 'citation': 'Coppadoro A, Bellani G, Bronco A, Lucchini A, Bramati S, Zambelli V, Marcolin R, Pesenti A. The use of a novel cleaning closed suction system reduces the volume of secretions within the endotracheal tube as assessed by micro-computed tomography: a randomized clinical trial. Ann Intensive Care. 2015 Dec;5(1):57. doi: 10.1186/s13613-015-0101-9. Epub 2015 Dec 30.'}]}, 'descriptionModule': {'briefSummary': 'Cleaning the endotracheal tube with a specifically designed device results in lower amount of secretions at extubation, assessed by micro CT scan'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients admitted to an ICU\n* 18 years old or more\n* expected to be intubated for more than 48 hours\n* less than 24 hours from intubation\n* fraction of inspired oxygen set at the ventilator \\<80%\n\nExclusion Criteria:\n\n* Current or past participation in another intervention trial conflicting with the present study\n* expected survival less than 24 hours\n* Acute severe asthma\n* Use of Extracorporeal membrane oxygenation (ECMO) or candidates for ECMO\n* Double lumen endotracheal tube in place\n* Conditions which pose the patient at high risk if inadvertent endotracheal tube displacement occurs (laryngeal edema, cervical spine trauma, upper airways diseases with difficult reintubation)\n* other contraindications posed by staff physicians'}, 'identificationModule': {'nctId': 'NCT01912105', 'briefTitle': 'Evaluation of a Closed Suction System to Remove Secretions From the Endotracheal Tube', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliera San Gerardo di Monza'}, 'officialTitle': 'Evaluation of a Closed Suction System to Remove Secretions From the Endotracheal Tube: a Randomized Trial', 'orgStudyIdInfo': {'id': '180-20130326'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'treatment', 'description': 'Airway Medix Closed Suction System', 'interventionNames': ['Device: Airway medix closed suction system']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control', 'description': 'standard closed suctioning systems', 'interventionNames': ['Device: standard closed suctioning systems']}], 'interventions': [{'name': 'Airway medix closed suction system', 'type': 'DEVICE', 'armGroupLabels': ['treatment']}, {'name': 'standard closed suctioning systems', 'type': 'DEVICE', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23900', 'city': 'Monza', 'country': 'Italy', 'facility': 'Azienda Ospedaliera San Gerardo', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}], 'overallOfficials': [{'name': 'Antonio Pesenti, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'San Gerardo Hospital'}, {'name': 'Giacomo Bellani, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'San Gerardo Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliera San Gerardo di Monza', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Antonio Pesenti', 'investigatorAffiliation': 'Azienda Ospedaliera San Gerardo di Monza'}}}}