Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2026-01-02 @ 10:50 AM
Study NCT ID:
NCT01082666
Status:
COMPLETED
Last Update Posted:
2015-06-18
First Post:
2010-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continuous Control of Tracheal Cuff Pressure and Microaspiration in Critically Ill Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 122}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-17', 'studyFirstSubmitDate': '2010-02-05', 'studyFirstSubmitQcDate': '2010-03-05', 'lastUpdatePostDateStruct': {'date': '2015-06-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pepsin level in tracheal aspirate', 'timeFrame': '48 h after randomization'}], 'secondaryOutcomes': [{'measure': 'Ventilator-associated pneumonia, tracheobronchial colonization, tracheal ischemic lesions', 'timeFrame': 'day 28 after randomization'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cuff pressure', 'microaspiration', 'pepsin', 'VAP', 'Mechanical ventilation'], 'conditions': ['Critically Ill']}, 'descriptionModule': {'briefSummary': 'We hypothesized that continuous control of tracheal cuff pressure would reduce microaspiration of gastric content as determined by pepsin level in tracheal aspirate.', 'detailedDescription': 'Randomized controlled open label study, performed in a 10-bed ICU. All patients intubated with a PVC-cuffed tracheal tube and receiving enteral nutrition who require at least 48 h of mechanical ventilation are eligible. Patients receive continuous control of cuff pressure using a pneumatic device (intervention group) or manual control using a manometer (control group). Target cuff pressure is 25 cmH2O.\n\nIn all patients, pepsin is measured in tracheal aspirate during a 48-h period after inclusion, as proxy for gastric content aspiration. In addition tracheobronchial colonization and ventilator associated pneumonia rates will be compared between the two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> or = 18 years\n* tracheal intubation using a polyvinylchloride tube\n* predictible duration of mechanical ventilation \\> 48 h\n* enteral nutrition\n\nExclusion Criteria:\n\n* refuse to participate to the study\n* no informed consent\n* contra-indication for semirecumbment position'}, 'identificationModule': {'nctId': 'NCT01082666', 'briefTitle': 'Continuous Control of Tracheal Cuff Pressure and Microaspiration in Critically Ill Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Phase 4 Study of Continuous Control of Tracheal Cuff Pressure and Microaspiration in Critically Ill Patients', 'orgStudyIdInfo': {'id': '2008_53/0919'}, 'secondaryIdInfos': [{'id': '2009-A00431-56', 'type': 'OTHER', 'domain': 'ID-RCB number, ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Continuous control', 'description': 'Continuous control of cuff pressure using a pneumatic device', 'interventionNames': ['Device: Continuous control of cuff pressure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Manual control', 'description': 'Manual control of cuff pressure is a routine practice in ICU patients', 'interventionNames': ['Device: Manual control of cuff pressure']}], 'interventions': [{'name': 'Continuous control of cuff pressure', 'type': 'DEVICE', 'otherNames': ['Automatic control of cuff pressure (Rusch, Kernen, Germany)'], 'description': 'Continuous control of cuff pressure using a pneumatic device (Nosten, Leved, France)', 'armGroupLabels': ['Continuous control']}, {'name': 'Manual control of cuff pressure', 'type': 'DEVICE', 'otherNames': ['Manual manometer'], 'description': 'Manual control of cuff pressure is a routine practice in ICU patients', 'armGroupLabels': ['Manual control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59037', 'city': 'Lille', 'state': 'Nord', 'country': 'France', 'facility': 'ICU, Calmette Hospital, University Hospital of Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Alain Durocher, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CHRU de Lille'}, {'name': 'Malika Balduyck, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CHU de Lille'}, {'name': 'Farid Zerimech, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CHU de Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}