Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2025-12-27 @ 8:09 PM
Study NCT ID:
NCT01948635
Status:
COMPLETED
Last Update Posted:
2025-12-22
First Post:
2013-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Tracheal Cuff Shape on Microaspiration in Intensive Care Units
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D053717', 'term': 'Pneumonia, Ventilator-Associated'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 326}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2013-08-31', 'studyFirstSubmitQcDate': '2013-09-18', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Microaspiration of gastric contents', 'timeFrame': '48 hours after randomization', 'description': 'Mesuerment of pepsin level in tracheal aspirate will be used to quantify microaspiration of gastric contents'}], 'secondaryOutcomes': [{'measure': 'Microaspiration of oropharyngeal secretions', 'timeFrame': '48 h after randomization', 'description': 'amylase level on tracheal aspirate would allow to quantify microaspiration of oropharyngeal secretions'}, {'measure': 'Tracheobronchial colonization', 'timeFrame': '28 days after randomization'}, {'measure': 'Ventilator-associated pneumonia', 'timeFrame': '28 days after randomization'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['tracheal cuff shape', 'microaspiration', 'pepsin', 'ventilator-associated pneumonia'], 'conditions': ['Critical Illness', 'Mechanical Ventilation Complication', 'Ventilator Associated Pneumonia']}, 'referencesModule': {'references': [{'pmid': '26407612', 'type': 'BACKGROUND', 'citation': 'Jaillette E, Brunin G, Girault C, Zerimech F, Chiche A, Broucqsault-Dedrie C, Fayolle C, Minacori F, Alves I, Barrailler S, Robriquet L, Tamion F, Delaporte E, Thellier D, Delcourte C, Duhamel A, Nseir S. Impact of tracheal cuff shape on microaspiration of gastric contents in intubated critically ill patients: study protocol for a randomized controlled trial. Trials. 2015 Sep 25;16:429. doi: 10.1186/s13063-015-0955-z.'}, {'pmid': '28303301', 'type': 'RESULT', 'citation': 'Jaillette E, Girault C, Brunin G, Zerimech F, Behal H, Chiche A, Broucqsault-Dedrie C, Fayolle C, Minacori F, Alves I, Barrailler S, Labreuche J, Robriquet L, Tamion F, Delaporte E, Thellier D, Delcourte C, Duhamel A, Nseir S; BestCuff Study Group and the BoReal Network. Impact of tapered-cuff tracheal tube on microaspiration of gastric contents in intubated critically ill patients: a multicenter cluster-randomized cross-over controlled trial. Intensive Care Med. 2017 Nov;43(11):1562-1571. doi: 10.1007/s00134-017-4736-x. Epub 2017 Mar 16.'}]}, 'descriptionModule': {'briefSummary': 'The investigators hypothesized that PVC tapered-cuff tracheal tubes would reduce microaspiration of gastric content as determined by pepsin level in tracheal aspirate.', 'detailedDescription': 'Microaspiration is the main route for entry of contaminated secretions into the lower respiratory tract of intubated critically ill patients. Tracheobronchial colonization might progress to ventilator-associated pneumonia (VAP) when the quantity and virulence of bacteria are high and when local and general host defenses are weak.\n\nRecent in vitro and animal studies suggest that tapered-cuff tracheal tubes could be associated with reduced microaspiration of contaminated secretions and might be helpful in preventing VAP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> or = 18 years\n* tracheal intubation\n* predictable duration of mechanical ventilation \\> 48h\n* enteral nutrition\n\nExclusion Criteria:\n\n* pregnant women\n* refuse to participate to the study\n* no informed consent\n* contre indication for semirecumbent position'}, 'identificationModule': {'nctId': 'NCT01948635', 'acronym': 'BestCuff', 'briefTitle': 'Impact of Tracheal Cuff Shape on Microaspiration in Intensive Care Units', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Impact of Tracheal Cuff Shape on Microaspiration in Intensive Care Units', 'orgStudyIdInfo': {'id': '2012_45'}, 'secondaryIdInfos': [{'id': '2013 A00534 41', 'type': 'OTHER', 'domain': 'ID-RCB number, ANSM'}, {'id': 'PHRCI_2012', 'type': 'OTHER', 'domain': 'PHRC numner, DGOS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'tapered PVC-cuffed tracheal tubes', 'description': 'Patients in this arm will be intubated with tapered PVC-tracheal tubes', 'interventionNames': ['Device: tapered PVC-cuffed tracheal tubes']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard PVC-cuffed tracheal tube', 'description': 'Patients in this arm will be intubated with standard (barrel-shape cuffed) PVC tracheal tubes', 'interventionNames': ['Device: Standard PVC-cuffed tracheal tube']}], 'interventions': [{'name': 'tapered PVC-cuffed tracheal tubes', 'type': 'DEVICE', 'description': 'Patients will be intubated with tapered-shape tracheal tubes', 'armGroupLabels': ['tapered PVC-cuffed tracheal tubes']}, {'name': 'Standard PVC-cuffed tracheal tube', 'type': 'DEVICE', 'description': 'Patients will be intubated with standard PVC cuffed tracheal tubes', 'armGroupLabels': ['Standard PVC-cuffed tracheal tube']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59035', 'city': 'Lille', 'state': 'Nord', 'country': 'France', 'facility': 'ICU, Salengro Hospital, University Hospital of Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Boulogne-sur-Mer', 'country': 'France', 'facility': 'centre Hospitalier', 'geoPoint': {'lat': 50.72485, 'lon': 1.61373}}, {'city': 'Dunkirk', 'country': 'France', 'facility': 'Centre Hospitalier', 'geoPoint': {'lat': 51.0344, 'lon': 2.37681}}, {'city': 'Lens', 'country': 'France', 'facility': 'Centre Hospitalier', 'geoPoint': {'lat': 50.43302, 'lon': 2.82791}}, {'city': 'Lomme', 'country': 'France', 'facility': 'Centre Hospitalier St Philibert', 'geoPoint': {'lat': 50.64358, 'lon': 2.98715}}, {'city': 'Roubaix', 'country': 'France', 'facility': 'Centre hospitalier', 'geoPoint': {'lat': 50.69421, 'lon': 3.17456}}, {'city': 'Rouen', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Tourcoing', 'country': 'France', 'facility': 'Centre Hospitalie', 'geoPoint': {'lat': 50.72391, 'lon': 3.16117}}, {'city': 'Valenciennes', 'country': 'France', 'facility': 'Centre Hospitalier', 'geoPoint': {'lat': 50.35909, 'lon': 3.52506}}], 'overallOfficials': [{'name': 'Saad Nseir, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHRU de Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}