Ignite Creation Date:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2026-01-04 @ 3:45 PM
Study NCT ID:
NCT01351259
Status:
COMPLETED
Last Update Posted:
2013-09-04
First Post:
2011-05-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continuous Control of Polyurethane Tracheal-cuff Pressure: Efficiency of a Pneumatic Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-31', 'studyFirstSubmitDate': '2011-05-09', 'studyFirstSubmitQcDate': '2011-05-09', 'lastUpdatePostDateStruct': {'date': '2013-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients with underinflation or overinflation of cuff pressure', 'timeFrame': '48 h', 'description': 'Continuous recording of cuff pressure will be performed during 2 24-h periods (with or without the pneumatic device)'}], 'secondaryOutcomes': [{'measure': 'Impact of tracheal-cuff shape on variations in cuff pressure', 'timeFrame': '48 h', 'description': 'Patients will be intubated with cylindrical or tapered polyurethane cuffed tubes.'}, {'measure': 'Impact of continuous control of cuff pressure on microaspiration of gastric contents', 'timeFrame': '48 h', 'description': 'Pepsin will be quantitatively measured in tracheal aspirates of all patients during the 2 24-h periods (with or without the pneumatic device)'}, {'measure': 'Impact of tracheal cuff shape on microaspiration of gastric contents', 'timeFrame': '48 h', 'description': 'Pepsin level in tracheal aspirates will be compared between patients intubated with cylindrical polyurethane cuffed-tubes versus those intubated with tapered polyurethane cuffed-tubes'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Mechanical ventilation', 'Intubation', 'Cuff pressure', 'Microaspiration'], 'conditions': ['Mechanical Ventilation Complication', 'Tracheal Intubation Morbidity']}, 'referencesModule': {'references': [{'pmid': '24369057', 'type': 'DERIVED', 'citation': 'Jaillette E, Zerimech F, De Jonckheere J, Makris D, Balduyck M, Durocher A, Duhamel A, Nseir S. Efficiency of a pneumatic device in controlling cuff pressure of polyurethane-cuffed tracheal tubes: a randomized controlled study. BMC Anesthesiol. 2013 Dec 26;13(1):50. doi: 10.1186/1471-2253-13-50.'}]}, 'descriptionModule': {'briefSummary': 'Underinflation and overinflation of tracheal cuff are common in intubated patients, including those intubated with polyurethane-cuffed tubes. The aim of this study is to determine the efficiency of a pneumatic device in controlling cuff pressure.', 'detailedDescription': 'Underinflation and overinflation of tracheal cuff are associated with severe complications such as microaspiration of contaminated secretions, and tracheal ischemia. Efficient control of cuff pressure would probably allow reducing complications related to variations in cuff pressure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients requiring intubation in the ICU\n* Predicted duration of mechanical ventilation \\> or = 48h\n* Age \\> or = 18 years\n\nExclusion Criteria:\n\n* Contraindication for semirecumbent position\n* Contraindication for enteral nutrition\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT01351259', 'acronym': 'Nosten', 'briefTitle': 'Continuous Control of Polyurethane Tracheal-cuff Pressure: Efficiency of a Pneumatic Device', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Continuous Control of Polyurethane Tracheal-cuff Pressure: Efficiency of a Pneumatic Device', 'orgStudyIdInfo': {'id': '2009-A00598-49'}, 'secondaryIdInfos': [{'id': '2009_20/0925', 'type': 'OTHER', 'domain': 'sponsor'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pneumatic device, tapered cuff', 'description': 'Intervention: continuous control of cuff pressure using a pneumatic device, tapered polyurethane cuff', 'interventionNames': ['Device: Pneumatic device, cylindrical or tapered cuff']}, {'type': 'EXPERIMENTAL', 'label': 'Pneumatic device, cylindrical cuff', 'description': 'Continuous control of cuff pressure using a pneumatic device in patients intubated with cylindrical polyurethane cuffed tracheal tubes', 'interventionNames': ['Device: Pneumatic device, cylindrical or tapered cuff']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Routine care, tapered cuff', 'description': 'Routine care of cuff pressure using a manometer, tapered polyurethane cuff', 'interventionNames': ['Device: Pneumatic device, cylindrical or tapered cuff']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Routine care, cylindrical cuff', 'description': 'Routine care of cuff pressure using a manometer, cylindrical polyurethane tracheal cuff', 'interventionNames': ['Device: Pneumatic device, cylindrical or tapered cuff']}], 'interventions': [{'name': 'Pneumatic device, cylindrical or tapered cuff', 'type': 'DEVICE', 'otherNames': ['Nosten', 'Kimberly clark', 'Covidien'], 'description': 'Continuous control of cuff pressure using a pneumatic device (Nosten) Cylindrical (Kimberly Clark tube) or tapered (Covidien tube) tracheal cuff', 'armGroupLabels': ['Pneumatic device, cylindrical cuff', 'Pneumatic device, tapered cuff', 'Routine care, cylindrical cuff', 'Routine care, tapered cuff']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59037', 'city': 'Lille', 'state': 'Nord', 'country': 'France', 'facility': 'ICU, Calmette Hospital, CHU de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Saad NSEIR, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Saad NSEIR', 'investigatorAffiliation': 'University Hospital, Lille'}}}}