Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2026-01-01 @ 8:23 AM
Study NCT ID:
NCT01828151
Status:
COMPLETED
Last Update Posted:
2013-04-10
First Post:
2013-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Noninvasive Positive Airway Pressure Ventilation and Risk of Facial Pressure Ulcers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003668', 'term': 'Pressure Ulcer'}], 'ancestors': [{'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 170}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-05', 'studyFirstSubmitDate': '2013-03-21', 'studyFirstSubmitQcDate': '2013-04-05', 'lastUpdatePostDateStruct': {'date': '2013-04-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Risk of skin pressure ulcers in patients treated with noninvasive ventilation for acute respiratory failure.', 'timeFrame': 'Risk of pressure ulcers within 72 hours from noninvasive ventilation beginning.', 'description': 'Skin lesions were classified as follows:\n\n* reddening,\n* loss of skin integrity,\n* necrotic lesion.'}], 'secondaryOutcomes': [{'measure': 'Incidence of skin pressure ulcers in patients treated with noninvasive ventilation.', 'timeFrame': 'Incidence of skin pressure ulcers. Patients will be followed during duration of high dependency unit stay for an average length of stay of 7 days.', 'description': 'Characterization of skin lesions during noninvasive ventilation in patients with acute respiratory failure.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pressure ulcer', 'Noninvasive ventilation'], 'conditions': ['Acute Respiratory Failure']}, 'descriptionModule': {'briefSummary': 'To assess risk of skin pressure lesions in patients treated with noninvasive mechanical ventilation.', 'detailedDescription': "Noninvasive ventilation improves the outcome of patients with acute respiratory failure; however patient's discomfort may be responsible for up to a fifth of failures. Scant literature exists on NIV-related pressure ulcers and their determinants.\n\nAim of the study is to seek for determinants, if any, associated with the development of pressure ulcers related to noninvasive ventilation.\n\nStudy design: observational. Patients treated with NIV from December 2009 to December 2011 will be analyzed. Main end-points: to seek for variables associated to the development of NIV-related pressure ulcers in patients with acute respiratory failure."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to our high dependency unit for an episode of acute respiratory failure and treated with noninvasive ventilation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* severe dyspnea at rest\n* respiratory rate \\> 30 per minute\n* PaO2/FiO2 \\< 200 (despite oxygen with Venturi with a FiO2 og 0.5)\n* use of accessory respiratory muscles\n* pH \\< 7.35 \\> 7.10\n\nExclusion Criteria:\n\n* STEMI\n* NSTEMI/Unstable angina\n* Hemodynamic instability\n* Need for immediate endotracheal intubation\n* Inability to protect the airways\n* Impaired sensorium\n* Pulmonary embolism\n* Gastrointestinal bleeding\n* Hematological malignancy or neoplasms with ECOG performance status \\> 2'}, 'identificationModule': {'nctId': 'NCT01828151', 'briefTitle': 'Noninvasive Positive Airway Pressure Ventilation and Risk of Facial Pressure Ulcers', 'organization': {'class': 'OTHER', 'fullName': 'Ospedale S. Giovanni Bosco'}, 'officialTitle': 'Noninvasive Positive Airway Pressure Ventilation and Risk of Facial Pressure Ulcers in Patients With Acute Respiratory Failure', 'orgStudyIdInfo': {'id': 'gbosco5'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Developed skin lesions', 'description': 'Patients treated with noninvasive ventilation for an episode of acute respiratory failure', 'interventionNames': ['Device: Noninvasive ventilation mask']}], 'interventions': [{'name': 'Noninvasive ventilation mask', 'type': 'DEVICE', 'otherNames': ['- Oro-nasal mask: Ultra Mirage NV, ResMed Australia', '- Full-face mask: Performax, Respironics Inc USA', '- Helmet: Castar R, StarMed - Mirandola Italy'], 'armGroupLabels': ['Developed skin lesions']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10154', 'city': 'Torino', 'state': 'Torino', 'country': 'Italy', 'facility': "Medicina d'Urgenza - Terapia Subintensiva. Ospedale S. Giovanni Bosco", 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}], 'overallOfficials': [{'name': 'Giovanni Ferrari, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ospedale S. Giovanni Bosco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ospedale S. Giovanni Bosco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Giovanni Ferrari', 'investigatorAffiliation': 'Ospedale S. Giovanni Bosco'}}}}