Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2026-03-03 @ 2:26 PM
Study NCT ID:
NCT02150018
Status:
UNKNOWN
Last Update Posted:
2015-07-31
First Post:
2014-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Non Invasive Ventilation on Lung Volumes Determined by Electrical Impedance Tomography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D063087', 'term': 'Noninvasive Ventilation'}], 'ancestors': [{'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-07-30', 'studyFirstSubmitDate': '2014-05-26', 'studyFirstSubmitQcDate': '2014-05-28', 'lastUpdatePostDateStruct': {'date': '2015-07-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '- End-expiratory lung volume (EELV) determined by electrical impedance tomography before, during and after NIV', 'timeFrame': 'at day 1'}], 'secondaryOutcomes': [{'measure': 'Anterior, medio-anterior, medio-posterior and posterior EELV', 'timeFrame': 'at day 1'}, {'measure': 'Ventilatory frequency', 'timeFrame': 'at day 1'}]}, 'conditionsModule': {'keywords': ['- Critical Care', 'Non invasive ventilation', 'Electrical impedance tomography', 'End expiratory lung volume', 'End expiratory lung impedance'], 'conditions': ['- Critical Care', 'Non Invasive Ventilation', 'Electrical Impedance Tomography', 'End Expiratory Lung Volume', 'End Expiratory Lung Impedance']}, 'descriptionModule': {'briefSummary': 'Effect of Non Invasive Ventilation on end-expiratory lung volumes determined by electrical impedance tomography', 'detailedDescription': 'Prospective clinical study in ICU with patients requiring non invasive ventilation (NIV) comparing lung volumes determined by electrical impedance tomography before, during and after NIV.\n\nDuration of NIV is 30 minutes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients requiring non invasive ventilation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult ICU patients requiring non invasive ventilation\n* Consent of patients or family\n* Arterial line\n\nExclusion Criteria:\n\n* Tracheotomized patients\n* Dressings in the thoracic area'}, 'identificationModule': {'nctId': 'NCT02150018', 'acronym': 'NIVIT', 'briefTitle': 'Effect of Non Invasive Ventilation on Lung Volumes Determined by Electrical Impedance Tomography', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Effect of Non Invasive Ventilation on Lung Volumes Determined by Electrical Impedance Tomography', 'orgStudyIdInfo': {'id': 'CHU-0193'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'non invasive ventilation (NIV)', 'interventionNames': ['Other: non invasive ventilation']}], 'interventions': [{'name': 'non invasive ventilation', 'type': 'OTHER', 'armGroupLabels': ['non invasive ventilation (NIV)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63003', 'city': 'Clermont-Ferrand', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Patrick LACARIN', 'role': 'CONTACT', 'email': 'placarin@chu-clermontferrand.fr', 'phone': '04 73 75 11 95'}], 'facility': 'CHU de Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'centralContacts': [{'name': 'Patrick LACARIN', 'role': 'CONTACT', 'email': 'placarin@chu-clermontferrand.fr', 'phone': '04 73 75 11 95'}], 'overallOfficials': [{'name': 'Sebastien PERBET', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Estaing', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}