Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2025-12-25 @ 8:06 PM
Study NCT ID:
NCT03573635
Status:
COMPLETED
Last Update Posted:
2018-07-10
First Post:
2018-05-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Continuous Supraglottic Aspiration in Intubated and Mechanically Ventilated Patients: the "SUPRAtube" Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011015', 'term': 'Pneumonia, Aspiration'}], 'ancestors': [{'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2017-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-09', 'studyFirstSubmitDate': '2018-05-31', 'studyFirstSubmitQcDate': '2018-06-19', 'lastUpdatePostDateStruct': {'date': '2018-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'aspirated secretions', 'timeFrame': '24 hours after intubation', 'description': 'volume of aspirated secretions'}], 'secondaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': '24 hours after intubation', 'description': 'Adverse events related to supratube device use'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Aspiration Pneumonias']}, 'descriptionModule': {'briefSummary': 'Purpose of the trial: Evaluate the efficacy and safety of the device of self-invention of continuous oropharyngeal aspiration denominated "SUPRAtube" in patients with orotracheal intubation and mechanical ventilation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Endotracheal intubation and invasive mechanical ventilation,\n\nExclusion Criteria:\n\n* Immediate postoperative oral cavity.\n* Traumatic oral cavity injury.\n* Platelet count less than 50000.'}, 'identificationModule': {'nctId': 'NCT03573635', 'acronym': 'Supratube', 'briefTitle': 'Continuous Supraglottic Aspiration in Intubated and Mechanically Ventilated Patients: the "SUPRAtube" Device', 'organization': {'class': 'OTHER', 'fullName': 'Fundación Cardiovascular de Colombia'}, 'officialTitle': 'Evaluation of the Effectiveness and Safety of an Own-invention System for Continuous Supraglottic Aspiration in Intubated and Mechanically Ventilated Patients: the "SUPRAtube" Device', 'orgStudyIdInfo': {'id': '004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Supratube', 'description': 'Patient with orotracheal intubation and supratube device', 'interventionNames': ['Device: Supratube', 'Other: Reference']}], 'interventions': [{'name': 'Supratube', 'type': 'DEVICE', 'description': 'Aspiration of orotracheal secretions with supratube device', 'armGroupLabels': ['Supratube']}, {'name': 'Reference', 'type': 'OTHER', 'description': 'Usual aspiration with any other device', 'armGroupLabels': ['Supratube']}]}, 'contactsLocationsModule': {'locations': [{'zip': '681011', 'city': 'Piedecuesta', 'state': 'Santander Department', 'country': 'Colombia', 'facility': 'Fundación Cardiovascular de Colombia', 'geoPoint': {'lat': 6.98789, 'lon': -73.04953}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación Cardiovascular de Colombia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}