Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2026-04-23 @ 1:32 PM
Study NCT ID:
NCT02109003
Status:
COMPLETED
Last Update Posted:
2015-06-02
First Post:
2014-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficiency of a Mechanical Device in Controlling Tracheal Cuff Pressure in Intubated Critically Ill Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-30', 'studyFirstSubmitDate': '2014-04-07', 'studyFirstSubmitQcDate': '2014-04-08', 'lastUpdatePostDateStruct': {'date': '2015-06-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of recording time spent with cuff overinflation or underinflation', 'timeFrame': '48 hours', 'description': 'Continuous recording of cuff pressure will be performed during two 24-h periods (with or without Pressure easy® device)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['tracheal cuff', 'cuff overinflation', 'cuff underinflation'], 'conditions': ['Cuff Overinflation', 'Cuff Underinflation']}, 'referencesModule': {'references': [{'pmid': '26059205', 'type': 'DERIVED', 'citation': 'Nseir S, Rodriguez A, Saludes P, De Jonckheere J, Valles J, Artigas A, Martin-Loeches I. Efficiency of a mechanical device in controlling tracheal cuff pressure in intubated critically ill patients: a randomized controlled study. Ann Intensive Care. 2015 Dec;5(1):54. doi: 10.1186/s13613-015-0054-z. Epub 2015 Jun 2.'}]}, 'descriptionModule': {'briefSummary': 'Despite intermittent control of tracheal cuff pressure using a manual manometer, cuff underinflation and overinflation frequently occur in critically ill patients, resulting in increased risk for microaspiration and tracheal ischemic lesions.', 'detailedDescription': 'The aim of this study is to determine the efficiency of Pressure easy® device (Smiths medical cuff pressure controller) in continuous control of tracheal cuff pressure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients intubated in the ICU with a polyvinyl chloride (PVC) cuffed tracheal tube.\n* Predicted duration of mechanical ventilation \\> or = 48h.\n* Age \\> or = 18 years.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Anticipated duration of mechanical ventilation\\<48h after randomization.\n* Tracheostomized patients.\n* Patients with contraindication for semirecumbent position.\n* Patients participating to another trial that might influence this study results.'}, 'identificationModule': {'nctId': 'NCT02109003', 'briefTitle': 'Efficiency of a Mechanical Device in Controlling Tracheal Cuff Pressure in Intubated Critically Ill Patients', 'organization': {'class': 'OTHER', 'fullName': 'Corporacion Parc Tauli'}, 'officialTitle': 'Efficiency of PressureEasy in Controlling Tracheal Cuff Pressure in Intubated Critically Ill Patients', 'orgStudyIdInfo': {'id': 'EPREI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Continuous control of Pcuff followed by manual control', 'description': 'Patients receive continuous control of cuff pressure with Pressure easy® device for 24h, followed by discontinuous control (every 4 hours) with a manual manometer for 24 h.', 'interventionNames': ['Device: Pressure easy® device']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Manual control of Pcuff followed by continuous control.', 'description': 'Patients receive the reverse sequence (manual control followed by continuous control of Pcuff)', 'interventionNames': ['Device: Manual control of Pcuff followed by continuous control.']}], 'interventions': [{'name': 'Pressure easy® device', 'type': 'DEVICE', 'otherNames': ['Pressure easy® device (Smiths medical cuff pressure controller)'], 'description': 'Continuous control of tracheal cuff pressure using a mechanical device for 24h followed by manual control of cuff pressure using a manometer.', 'armGroupLabels': ['Continuous control of Pcuff followed by manual control']}, {'name': 'Manual control of Pcuff followed by continuous control.', 'type': 'DEVICE', 'description': 'Control 24h with manual control using a manometer followed by 24h of continuous control using a mechanical device.', 'armGroupLabels': ['Manual control of Pcuff followed by continuous control.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08208', 'city': 'Sabadell', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Area de Críticos, Hospital de Sabadell, Corporación Sanitaria y Universitaria Parc Taulí', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}], 'overallOfficials': [{'name': 'Andrey Rodriguez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Critical Care Unit. Hospital de Sabadell, Corporación Sanitaria y Universitaria Parc Taulí'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corporacion Parc Tauli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Critical Care Unit', 'investigatorFullName': 'Antonio Artigas Raventós', 'investigatorAffiliation': 'Corporacion Parc Tauli'}}}}