Ignite Creation Date:
2025-12-24 @ 1:02 PM
Ignite Modification Date:
2026-01-06 @ 2:25 PM
Study NCT ID:
NCT00219661
Status:
COMPLETED
Last Update Posted:
2007-04-23
First Post:
2005-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Drainage of Subglottic Secretions on Pneumonia Acquired Under Mechanical Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2009-03-02', 'releaseDate': '2009-02-04'}], 'estimatedResultsFirstSubmitDate': '2009-02-04'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D053717', 'term': 'Pneumonia, Ventilator-Associated'}], 'ancestors': [{'id': 'D000077299', 'term': 'Healthcare-Associated Pneumonia'}, {'id': 'D003428', 'term': 'Cross Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 440}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-04', 'completionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-04-20', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-19', 'lastUpdatePostDateStruct': {'date': '2007-04-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of ventilator-associated pneumonia(VAP)'}], 'secondaryOutcomes': [{'measure': 'Duration on mechanical ventilation (MV)'}, {'measure': 'Prior duration of MV before occurrence of VAP'}, {'measure': "duration of ICU's stay"}, {'measure': 'Rate of tracheotomy'}, {'measure': "ICU's mortality"}, {'measure': 'Microbiology of the VAP'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['randomised control trial', 'intensive care unit', 'mechanical ventilation', 'ventilator-associated pneumonia', 'drainage of subglottic secretions'], 'conditions': ["ICU's Patients Under Mechanical Ventilation"]}, 'referencesModule': {'references': [{'pmid': '20522796', 'type': 'DERIVED', 'citation': 'Lacherade JC, De Jonghe B, Guezennec P, Debbat K, Hayon J, Monsel A, Fangio P, Appere de Vecchi C, Ramaut C, Outin H, Bastuji-Garin S. Intermittent subglottic secretion drainage and ventilator-associated pneumonia: a multicenter trial. Am J Respir Crit Care Med. 2010 Oct 1;182(7):910-7. doi: 10.1164/rccm.200906-0838OC. Epub 2010 Jun 3.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine whether drainage of subglottic secretions is effective to reduce the incidence of pneumonia acquired under mechanical ventilation in ICU's patients.", 'detailedDescription': "Nosocomial infection represent a major problem in hospitals. In intensive care units, ventilator-associated pneumonia (VAP) is associated with an increase in morbidity and mortality. Incidence of VAP is high, 20 to 30% of patients under mechanical ventilation (MV) for more than 48 hours. In the pathogenesis of VAP, two processes are considered essential for its development: bacterial colonization of the oropharynx and tracheobronchial tract, followed by aspiration of contaminated secretions into the lower airways. It has been shown that pooled secretions above inflated endotracheal tube cuffs may be source of aspiration and can be a cause of VAP. Several studies have suggested that recurrent aspiration of subglottic secretions can be prevented by intermittent drainage of subglottic secretions. Nevertheless, recent CDC guideline reported that there was not enough evidence to conclude on the efficacy of such intervention.\n\nDuring the study, patients, in both groups, will be intubated with the same device permitting subglottic drainage (HiLo Evac endotracheal tube). The daily screening of VAP will be performed until the 28th days of mechanical ventilation without occurrence of VAP. The follow-up of each patient will be realized until the ICU's discharge.\n\nComparison: The incidence of VAP will be compared between two groups: one group with intermittent drainage of subglottic secretions and the other one without this intervention."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ICU patients expected to require MV more than 48 hours\n\nExclusion Criteria:\n\n* patients already intubated for more than 12 hours\n* patients intubated with another tube than the HiLo Evac tube\n* patients admitted for cardiac arrest\n* patients admitted for self poisoning\n* patients admitted with tracheotomy\n* patients already included in an another clinical trial'}, 'identificationModule': {'nctId': 'NCT00219661', 'briefTitle': 'Effect of Drainage of Subglottic Secretions on Pneumonia Acquired Under Mechanical Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'Poissy-Saint Germain Hospital'}, 'officialTitle': 'Impact of Drainage of Subglottic Secretions on Ventilator-Associated Pneumonia:a Randomised Multicentre Trial', 'orgStudyIdInfo': {'id': '323'}}, 'armsInterventionsModule': {'interventions': [{'name': 'drainage of subglottic secretions (HiLo Evac tube)', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '84 000', 'city': 'Avignon', 'country': 'France', 'facility': 'Avignon Hospital', 'geoPoint': {'lat': 43.94834, 'lon': 4.80892}}, {'zip': '78', 'city': 'Le Chesnay', 'country': 'France', 'facility': 'André Mignot Hospital', 'geoPoint': {'lat': 48.8222, 'lon': 2.12213}}, {'zip': '78300', 'city': 'Poissy', 'country': 'France', 'facility': 'Poissy Saint-Germain Hospital', 'geoPoint': {'lat': 48.92902, 'lon': 2.04952}}, {'zip': '78', 'city': 'Saint-Germain-en-Laye', 'country': 'France', 'facility': 'Poisyy Saint-Germain Hospital', 'geoPoint': {'lat': 48.89643, 'lon': 2.0904}}], 'overallOfficials': [{'name': 'Jean-Claude Lacherade, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical Intensive Care Unit, Poissy-Saint-Germain Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poissy-Saint Germain Hospital', 'class': 'OTHER'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2009-02-04', 'type': 'RELEASE'}, {'date': '2009-03-02', 'type': 'RESET'}], 'unpostedResponsibleParty': 'LACHERADE Jean-Claude, MD, Poissy-Saint Germain Hospital'}}}}