Ignite Creation Date:
2025-12-26 @ 12:14 PM
Ignite Modification Date:
2026-02-28 @ 3:49 AM
Study NCT ID:
NCT00568100
Status:
COMPLETED
Last Update Posted:
2015-04-28
First Post:
2007-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Pressure Support Ventilation and Neurally Adjusted Ventilatory Assist (NAVA) in Chronic Obstructive Pulmonary Disease (COPD) Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-27', 'studyFirstSubmitDate': '2007-12-04', 'studyFirstSubmitQcDate': '2007-12-04', 'lastUpdatePostDateStruct': {'date': '2015-04-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Respiratory mechanics, gas exchange, work of breathing', 'timeFrame': '5 minutes'}], 'secondaryOutcomes': [{'measure': 'Comfort of breathing', 'timeFrame': '5 minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['gas exchange', 'pressure support ventilation', 'respiratory mechanics', 'COPD', 'NAVA'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': "The investigators' aim is to study the effect of pressure support ventilation at two levels of PEEP and Pressure Support versus neurally adjusted ventilatory assist (NAVA) in COPD patients.", 'detailedDescription': "In this study, two levels of pressure support and PEEP during pressure support ventilation are compared with neurally adjusted ventilatory assist (NAVA) in COPD patients by measuring respiratory mechanics, intrinsic PEEP, work of breathing and patient's level of comfort."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stable COPD patients during non invasive mechanical ventilation\n\nExclusion Criteria:\n\n* Haemodynamic instability\n* Coma'}, 'identificationModule': {'nctId': 'NCT00568100', 'briefTitle': 'Effect of Pressure Support Ventilation and Neurally Adjusted Ventilatory Assist (NAVA) in Chronic Obstructive Pulmonary Disease (COPD) Patients', 'organization': {'class': 'OTHER', 'fullName': 'Policlinico Hospital'}, 'officialTitle': 'Effect of Pressure Support Ventilation and Neurally Adjusted Ventilatory Assist (NAVA) in COPD Patients', 'orgStudyIdInfo': {'id': '2222'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'COPD patients', 'interventionNames': ['Procedure: PSV and NAVA']}], 'interventions': [{'name': 'PSV and NAVA', 'type': 'PROCEDURE', 'description': 'evaluated the effect of PSV and NAVA on breathing pattern, respiratory effort, gas exchange and level of breathing comfort in COPD patients', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20122', 'city': 'Milan', 'country': 'Italy', 'facility': 'Policlinico Hospital', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}], 'overallOfficials': [{'name': 'Davide Chiumello, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Policlinico Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Policlinico Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Davide Chiumello', 'investigatorAffiliation': 'Policlinico Hospital'}}}}