Ignite Creation Date:
2025-12-24 @ 1:42 PM
Ignite Modification Date:
2026-02-17 @ 6:47 PM
Study NCT ID:
NCT01882595
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
2013-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Tracheostomy on Lung Deposition in Spontaneously Breathing Patient
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-18', 'studyFirstSubmitDate': '2013-06-18', 'studyFirstSubmitQcDate': '2013-06-18', 'lastUpdatePostDateStruct': {'date': '2013-06-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amikacin urinary drug concentration', 'timeFrame': 'At each micturition during 24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Nebulization aerosol nebulizer tracheostomy'], 'conditions': ['Tracheostomized Patients']}, 'descriptionModule': {'briefSummary': 'To compare lung deposition of amikacin in two settings: spontaneously breathing through a tracheostomy cannula and through the mouth.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient who were likely to require an elective tracheostomy surgery as part as their head and neck surgery\n\nExclusion Criteria:\n\n* Allergy to Aminoglycosides\n* Patients who received Aminoglycosides treatment less than one month prior the surgery\n* Pectoralis major flap reconstruction\n* Latissimus dorsi flap reconstruction'}, 'identificationModule': {'nctId': 'NCT01882595', 'briefTitle': 'Influence of Tracheostomy on Lung Deposition in Spontaneously Breathing Patient', 'organization': {'class': 'OTHER', 'fullName': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}, 'officialTitle': 'Influence of Tracheostomy on Lung Deposition in Spontaneously Breathing Patient', 'orgStudyIdInfo': {'id': 'Nebu Tracheo'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nebulization through the tracheostomy', 'description': 'Each subjects received two nebulization sessions. The first session was performed prior the tracheostomy removal (through the tracheostomy) and the second one when the when the tracheostome was totally scared (through the mouth)', 'interventionNames': ['Other: Nebulization through the tracheostomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nebulization through the mouth', 'description': 'Each subjects received two nebulization sessions. The first session was performed prior the tracheostomy removal (through the tracheostomy) and the second one when the when the tracheostome was totally scared (through the mouth)', 'interventionNames': ['Other: Nebulization through the mouth']}], 'interventions': [{'name': 'Nebulization through the tracheostomy', 'type': 'OTHER', 'description': 'Each subject received two nebulization sessions under spontaneous breathing in a sitting position. The first session was performed prior to tracheostomy removal. During the first nebulization, subjects inhaled the aerosol through the tracheostomy, cuff inflated and inner cannula removed.', 'armGroupLabels': ['Nebulization through the tracheostomy']}, {'name': 'Nebulization through the mouth', 'type': 'OTHER', 'description': 'Each subject received two nebulization sessions under spontaneous breathing in a sitting position. The second nebulization was performed when the tracheostome was totally scarred. During the second nebulization, subjects inhaled the aerosol a mouth piece and wore a nose clip.', 'armGroupLabels': ['Nebulization through the mouth']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Cliniques Universitaires Saint-Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor in physiotherapy', 'investigatorFullName': 'laurentpitance', 'investigatorAffiliation': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}}}}