Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-03-03 @ 3:30 PM
Study NCT ID:
NCT02510105
Status:
UNKNOWN
Last Update Posted:
2015-07-28
First Post:
2015-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tomodensitometric Study of Pulmonary Effects of Intrapulmonary Percussive Ventilation in ARDS Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014057', 'term': 'Tomography, X-Ray Computed'}, {'id': 'D007440', 'term': 'Intubation'}], 'ancestors': [{'id': 'D007090', 'term': 'Image Interpretation, Computer-Assisted'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011856', 'term': 'Radiographic Image Enhancement'}, {'id': 'D007089', 'term': 'Image Enhancement'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D014056', 'term': 'Tomography, X-Ray'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-07-27', 'studyFirstSubmitDate': '2015-06-01', 'studyFirstSubmitQcDate': '2015-07-27', 'lastUpdatePostDateStruct': {'date': '2015-07-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline (H0) in volume of overinflated lung at H1', 'timeFrame': 'at Hour 0(just before Intrapulmonary Percussive Ventilation) and Hour 1(just after Intrapulmonary Percussive Ventilation)'}], 'secondaryOutcomes': [{'measure': 'Volume of normally aerated lung', 'timeFrame': 'at Hour 0 (just before Intrapulmonary Percussive Ventilation ) and Hour 1 (just after Intrapulmonary Percussive Ventilation)'}, {'measure': 'Volume of recruited lung', 'timeFrame': 'at day 1 (between H0 and H1)'}, {'measure': 'Heart rate', 'timeFrame': 'at day 1 ((every 10 min between H0 and H1)'}, {'measure': 'Blood pressure', 'timeFrame': 'at day 1 (every 10 min between H0 and H1)'}, {'measure': 'Arterial blood gaz', 'timeFrame': 'at day 1 ((every 10 min between H0 and H1)'}, {'measure': 'Evolution of catecholamine doses (µg/Kg/min)', 'timeFrame': 'at day 1 (every 10 min between H0 and H1)'}]}, 'conditionsModule': {'keywords': ['Critical Care', 'ARDS', 'Intrapulmonary Percussive Ventilation', 'VDR4', 'Lung aeration', 'CT scan'], 'conditions': ['ARDS']}, 'referencesModule': {'references': [{'pmid': '29325586', 'type': 'DERIVED', 'citation': 'Godet T, Jabaudon M, Blondonnet R, Tremblay A, Audard J, Rieu B, Pereira B, Garcier JM, Futier E, Constantin JM. High frequency percussive ventilation increases alveolar recruitment in early acute respiratory distress syndrome: an experimental, physiological and CT scan study. Crit Care. 2018 Jan 11;22(1):3. doi: 10.1186/s13054-017-1924-6.'}]}, 'descriptionModule': {'briefSummary': 'The study is intended to elucidate the pulmonary effects of Intrapulmonary Percussive Ventilation (IPV) with VDR4 ventilator of patients with ARDS, using computed tomography (CT).', 'detailedDescription': "Prospective clinical study in ICU of ventilated patients with ARDS. The morphologic pulmonary effects of IPV with VDR4 are not known to the investigators' knowledge.\n\nThe main aim is to quantify recruited, normally aerated and overinflated parts of the lungs after a 1 hour treatment with IPV.\n\nPatients with ARDS (focal and non focal) consecutively admitted to the investigators' ICU are enrolled after informed consent.\n\nPatients are intubated and ventilated with Servo-I (GE) and ventilation is optimized according to ARDS-network recommandations.\n\nA first thoracic CT-scan is performed with ICU ventilator and then the patient is ventilated with VDR4 during 1 hour.\n\nA second thoracic CT-scan is then performed and the patient re-ventilated with ICU ventilator.\n\nArterial blood gases and hemodynamic parameters are recorded during experiments.\n\nCT-scan are analysed and compared for normally aerated, overinflated and recruited lung parenchyma. Regions are determined thanks to their Hounsfield units (HU)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ventilated more than 48 h\n* Sedated patients\n* ARDS moderate or severe (Berlin 2012)\n* Patients who have given their consent or his family\n* Patients aged between 18 and 85 years\n\nExclusion Criteria:\n\n* Pregnant ou lactating women\n* Hemodynamic instability\n* Chronic respiratory insufficiency.\n* Pneumothorax\n* Fistulae bronchopleural'}, 'identificationModule': {'nctId': 'NCT02510105', 'acronym': 'PERVE-ARDS', 'briefTitle': 'Tomodensitometric Study of Pulmonary Effects of Intrapulmonary Percussive Ventilation in ARDS Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Tomodensitometric Study of Pulmonary Effects of Intrapulmonary Percussive Ventilation in ARDS Patients', 'orgStudyIdInfo': {'id': 'CHU-0236'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ARDS patients', 'interventionNames': ['Device: VDR4 ventilator (Intrapulmonary Percussive Ventilation)', 'Device: CT scan', 'Device: Servo-i', 'Device: - Intubation', 'Device: Ventilation ( with an ICU conventional ventilator)']}], 'interventions': [{'name': 'VDR4 ventilator (Intrapulmonary Percussive Ventilation)', 'type': 'DEVICE', 'armGroupLabels': ['ARDS patients']}, {'name': 'CT scan', 'type': 'DEVICE', 'armGroupLabels': ['ARDS patients']}, {'name': 'Servo-i', 'type': 'DEVICE', 'armGroupLabels': ['ARDS patients']}, {'name': '- Intubation', 'type': 'DEVICE', 'armGroupLabels': ['ARDS patients']}, {'name': 'Ventilation ( with an ICU conventional ventilator)', 'type': 'DEVICE', 'armGroupLabels': ['ARDS patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'contacts': [{'name': 'Patrick LACARIN', 'role': 'CONTACT', 'email': 'placarin@chu-clermontferrand.fr', 'phone': '04 73 75 11 95'}, {'name': 'Jean-Michel CONSTANTIN', 'role': 'PRINCIPAL_INVESTIGATOR'}], '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': 'Jean-Michel CONSTANTIN', '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'}}}}