Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2025-12-26 @ 1:49 AM
Study NCT ID:
NCT01322659
Status:
COMPLETED
Last Update Posted:
2013-01-31
First Post:
2011-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Weaning Using Noninvasive Positive Pressure Ventilation by Means of Helmet in Patients With Acute Respiratory Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006260', 'term': 'Head Protective Devices'}], 'ancestors': [{'id': 'D000067393', 'term': 'Personal Protective Equipment'}, {'id': 'D011482', 'term': 'Protective Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-30', 'studyFirstSubmitDate': '2011-03-21', 'studyFirstSubmitQcDate': '2011-03-23', 'lastUpdatePostDateStruct': {'date': '2013-01-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weaning using noninvasive positive pressure ventilation by means of helmet in patients with acute respiratory failure', 'timeFrame': '30 days', 'description': 'Main end-point defined as the weaning success/failure rate'}], 'secondaryOutcomes': [{'measure': 'Weaning using noninvasive positive pressure ventilation by means of helmet in patients with acute respiratory failure', 'timeFrame': '180 days', 'description': '* Intubation duration\n* Total duration of mechanical ventilation (endotracheal and non invasive)\n* Weaning process duration\n* Stress response evaluation\n* Daily duration of ventilatory support\n* ICU lentgh of stay\n* Hospital lentgh of stay'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Mechanical ventilation', 'Weaning', 'Noninvasive ventilation', 'Acute respiratory failure', 'Helmet'], 'conditions': ['Inadequate or Impaired Breathing Pattern or Ventilation']}, 'referencesModule': {'references': [{'pmid': '24793658', 'type': 'DERIVED', 'citation': 'Carron M, Rossi S, Carollo C, Ori C. Comparison of invasive and noninvasive positive pressure ventilation delivered by means of a helmet for weaning of patients from mechanical ventilation. J Crit Care. 2014 Aug;29(4):580-5. doi: 10.1016/j.jcrc.2014.03.035. Epub 2014 Apr 5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether helmet is effective as device for noninvasive positive pressure ventilation in the weaning from mechanical ventilation.', 'detailedDescription': 'The clinical efficacy of noninvasive positive pressure ventilation (NPPV) has been demonstrated. Interest has emerged in using NPPV to facilitate earlier removal of an endotracheal tube and decrease complications associated with prolonged intubation. Studies assessing NPPV in weaning are not enough and generally are performed with face masks as device for NPPV. This study assesses the efficacy of helmet as device for NPPV during weaning from mechanical ventilation in an ICU and compares this procedure with invasive mechanical complication (IMV) by analyzing respiratory parameters, clinical course and complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* endotracheal mechanical ventilation for 48 hours or more for acute respiratory failure,\n* patient ready to be weaned (steady respiratory and hemodynamic conditions for 24 hours),\n* spontaneous breathing trial failure\n* written informed consent obtained (patient or family)\n\nExclusion Criteria:\n\n* respiratory and hemodynamic instability\n* initial difficult intubation\n* bronchial hypersecretion at the weaning time\n* non cooperant patient\n* recent history of upper gastro-intestinal surgery\n* recent history of myocardial infarction'}, 'identificationModule': {'nctId': 'NCT01322659', 'briefTitle': 'Weaning Using Noninvasive Positive Pressure Ventilation by Means of Helmet in Patients With Acute Respiratory Failure', 'organization': {'class': 'OTHER', 'fullName': 'University of Padova'}, 'officialTitle': 'Weaning Using Noninvasive Positive Pressure Ventilation by Means of Helmet in Patients With Acute Respiratory Failure', 'orgStudyIdInfo': {'id': '1926P'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Helmet NPPV', 'description': 'Weaning from mechanical ventilation with noninvasive positive pressure ventilation (NPPV)delivered by means of the helmet', 'interventionNames': ['Device: Helmet']}, {'type': 'SHAM_COMPARATOR', 'label': 'ETT IMV', 'description': 'Weaning from mechanical ventilation with standard invasive mechanical ventilation (IMV) delivered by means of the endotracheal tube (ETT)', 'interventionNames': ['Device: Endotracheal tube']}], 'interventions': [{'name': 'Helmet', 'type': 'DEVICE', 'description': 'Weaning from mechanical ventilation with noninvasive positive pressure ventilation delivered by means of the helmet', 'armGroupLabels': ['Helmet NPPV']}, {'name': 'Endotracheal tube', 'type': 'DEVICE', 'description': 'Weaning from mechanical ventilation with invasive mechanical ventilation delivered by means of the endotracheal tube', 'armGroupLabels': ['ETT IMV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35128', 'city': 'Padua', 'country': 'Italy', 'facility': 'University Medical Hospital', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}], 'overallOfficials': [{'name': 'Michele Carron, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University medical hospital of Padova'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Padova', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}