Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2026-02-20 @ 1:44 PM
Study NCT ID:
NCT01645358
Status:
COMPLETED
Last Update Posted:
2014-10-07
First Post:
2012-03-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Helmet Ventilation in Acute Hypercapnic Respiratory Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-05', 'studyFirstSubmitDate': '2012-03-22', 'studyFirstSubmitQcDate': '2012-07-18', 'lastUpdatePostDateStruct': {'date': '2014-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Arterial Blood gases', 'timeFrame': 'at 1 hour after the start of NIV'}], 'secondaryOutcomes': [{'measure': 'Arterial Blood Gases', 'timeFrame': 'Once a day at 8 am until discharge'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD', 'NIV', 'Acute Hypercapnic Respiratory Failure', 'COPD patients with hypercapnic respiratory failure'], 'conditions': ['Hypercapnic Respiratory Failure', 'Chronic Obstructive Pulmonary Disease']}, 'referencesModule': {'references': [{'pmid': '25504992', 'type': 'DERIVED', 'citation': 'Pisani L, Mega C, Vaschetto R, Bellone A, Scala R, Cosentini R, Musti M, Del Forno M, Grassi M, Fasano L, Navalesi P, Nava S. Oronasal mask versus helmet in acute hypercapnic respiratory failure. Eur Respir J. 2015 Mar;45(3):691-9. doi: 10.1183/09031936.00053814. Epub 2014 Dec 10.'}]}, 'descriptionModule': {'briefSummary': 'Lack of tolerance to the treatment, makes the interface choice for non-invasive ventilation (NIV) one of the key factor. To date the helmet is rarely used in Acute Hypercapnic Respiratory Failure (AHRF), because of its large dead space, despite in hypoxic respiratory failure, it is largely employed as a "rotating" strategy when the facial mask is poorly tolerated.\n\nIn a multicenter randomized controlled trial, the investigators will compare the clinical efficacy of a new helmet designed to specifically improve the performance in chronic obstructive pulmonary disease (COPD) versus a full face mask during an episode of AHRF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pH \\< 7,35 and PaCO2 \\> 45 mmHg\n* respiratory rate \\> 20 b/min\n\nExclusion Criteria:\n\n* hypoxic respiratory failure\n* coma\n* inability to stand NIV\n* lack of informed consent'}, 'identificationModule': {'nctId': 'NCT01645358', 'briefTitle': 'Helmet Ventilation in Acute Hypercapnic Respiratory Failure', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}, 'officialTitle': 'Hypercapnic Acute Respiratory Failure: Is the Helmet an Effective Interface?"', 'orgStudyIdInfo': {'id': '1222'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Helmet to deliver NIV', 'interventionNames': ['Device: Helmet (Starmed)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Total Face to deliver NIV', 'interventionNames': ['Device: Total Face mask (Respironics)']}], 'interventions': [{'name': 'Helmet (Starmed)', 'type': 'DEVICE', 'otherNames': ['Starmed Helmet'], 'description': 'The helmet is a kind of interface similar to a hood to deliver NIV', 'armGroupLabels': ['Helmet to deliver NIV']}, {'name': 'Total Face mask (Respironics)', 'type': 'DEVICE', 'otherNames': ['Respironics Performax or similar'], 'description': 'The total face mask is the "classical" interface for NIV delivery', 'armGroupLabels': ['Total Face to deliver NIV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40185', 'city': 'Bologna', 'country': 'Italy', 'facility': "Sant'Orsola malpighi Hospital", 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '40185', 'city': 'Bologna', 'country': 'Italy', 'facility': "Sant'Orsola Malpighi", 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Respiratory and Critical care', 'investigatorFullName': 'dr. Stefano Nava', 'investigatorAffiliation': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}}}}