Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-02-25 @ 4:58 PM
Study NCT ID:
NCT02813005
Status:
UNKNOWN
Last Update Posted:
2017-02-20
First Post:
2016-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Frequency Jet Ventilation for Percutaneous Interventional Radiology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 108}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2018-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-17', 'studyFirstSubmitDate': '2016-06-14', 'studyFirstSubmitQcDate': '2016-06-23', 'lastUpdatePostDateStruct': {'date': '2017-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to hit the target', 'timeFrame': 'during the procedure', 'description': 'Estimated the time for a puncture needle under High Frequency Jet Ventilation compared to the conventional mode of mechanical ventilation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['High frequency jet ventilation'], 'conditions': ['Percutaneous Tumor Ablation']}, 'descriptionModule': {'briefSummary': 'Evaluate benefits of High Frequency Jet Ventilation compare to standard ventilation during general anesthesia in patient undergoing peri diaphragmatic percutaneous tumor ablation.\n\nThe investigators hypothesis that procedure is shorter and more accurate in High Frequency Jet Ventilation group reducing target movement induced by ventilation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* use of percutaneous ablation tumor techniques (\\<3cm) for inferior lung, superior kidney, superior liver or adrenal gland lesion\n\nExclusion Criteria:\n\n* Severe chronic obstructive pulmonary disease\n* Recent pneumothorax (one month)\n* Recent thoracic surgery (one month)\n* Body Mass Index \\> 40'}, 'identificationModule': {'nctId': 'NCT02813005', 'briefTitle': 'High Frequency Jet Ventilation for Percutaneous Interventional Radiology', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'High Frequency Jet Ventilation for Percutaneous Interventional Radiology', 'orgStudyIdInfo': {'id': '6370'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Jet ventilation/ group A', 'description': 'Frequency : 120-200/min Pressure : 1-2 bars Inspiratory fraction of oxygen : 100% and 50% if Expiratory pressure : 5 -10 cmH2O', 'interventionNames': ['Procedure: Jet ventilation group']}, {'type': 'SHAM_COMPARATOR', 'label': 'Standard ventilation/ group B', 'description': 'Apnea made by the anesthesiologist to the request of the radiologist.', 'interventionNames': ['Procedure: Standard ventilation group']}], 'interventions': [{'name': 'Jet ventilation group', 'type': 'PROCEDURE', 'otherNames': ['Frequence: 120-200/min; Pressure: 1-2 bars; Inspiratory fraction of Oxgen: 50%; Expiratory pressure: 5-10 cmH2O'], 'description': 'MONSOON III™ (Acutronic Medical System AG®, SEBAC) with Double lumen catheter 12CH (Acutronic Medical System AG®, SEBAC)', 'armGroupLabels': ['Jet ventilation/ group A']}, {'name': 'Standard ventilation group', 'type': 'PROCEDURE', 'otherNames': ['apnea made by the anesthesiologist with Primus DRAGER Medical'], 'description': 'apnea made by the anesthesiologist to the request of the radiologist', 'armGroupLabels': ['Standard ventilation/ group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Hôpitaux Universitaires de Starsbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Sandra PETIOT, MD', 'role': 'CONTACT', 'email': 'Sandra.Petiot@chru-strasbourg.fr', 'phone': '+33 369550443'}], 'overallOfficials': [{'name': 'Sandra PETIOT, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Les Hôpitaux Universitaires de Strasbourg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}