Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2026-02-13 @ 4:31 AM
Study NCT ID:
NCT02537366
Status:
COMPLETED
Last Update Posted:
2017-03-09
First Post:
2015-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexmedetomidine for Non-invasive Ventilation After Chest Trauma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013898', 'term': 'Thoracic Injuries'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-08', 'studyFirstSubmitDate': '2015-08-21', 'studyFirstSubmitQcDate': '2015-08-31', 'lastUpdatePostDateStruct': {'date': '2017-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of NIV session', 'timeFrame': 'During ICU stay (expected average of 2 weeks)', 'description': 'Minutes'}], 'secondaryOutcomes': [{'measure': 'Richmond Agitation-Sedation Scale', 'timeFrame': 'During ICU stay (expected average of 2 weeks)', 'description': 'From -5 (Unarousable) to +4 (Combative)'}, {'measure': 'Number of interventions on NIV settings', 'timeFrame': 'During ICU stay (expected average of 2 weeks)'}, {'measure': 'Morphine consumption', 'timeFrame': 'During ICU stay (expected average of 2 weeks)', 'description': 'Morphine administration during NIV session (mg/kg/h)'}, {'measure': 'Ketamine consumption', 'timeFrame': 'During ICU stay (expected average of 2 weeks)', 'description': 'Ketamine administration during NIV session (mg/kg/h)'}, {'measure': 'Pain visual analogue scale', 'timeFrame': 'During ICU stay (expected average of 2 weeks)', 'description': 'From 0 (no pain) to 10 (worst pain possible)'}, {'measure': 'Variation of arterial partial pressure of Carbon dioxide (CO2) before and after NIV session', 'timeFrame': 'During ICU stay (expected average of 2 weeks)', 'description': 'mmHg'}, {'measure': 'Variation of arterial partial pressure of dioxygen (O2) before and after NIV session', 'timeFrame': 'During ICU stay (expected average of 2 weeks)', 'description': 'mmHg'}, {'measure': 'Variation of potential hydrogen (pH) before and after NIV session', 'timeFrame': 'During ICU stay (expected average of 2 weeks)'}, {'measure': 'Reproductibility of NIV sessions', 'timeFrame': 'During ICU stay (expected average of 2 weeks)', 'description': 'Minutes'}, {'measure': 'Bradycardia', 'timeFrame': 'During ICU stay (expected average of 2 weeks)', 'description': 'Mean arterial pressure less than 55 mmHg'}, {'measure': 'Hypotension', 'timeFrame': 'During ICU stay (expected average of 2 weeks)', 'description': 'Heart rate less than 40 / mn'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Thoracic Injuries']}, 'descriptionModule': {'briefSummary': 'Crossover randomized controlled double blinded trial :\n\n* The primary endpoint is the duration of Non Invasive Ventilation (NIV) session (minutes) with dexmedetomidine (DEX) or placebo.\n* Secondary endpoints will be the sedation level as assessed by the Richmond Agitation Sedation Scale (RASS), the number of interventions to allow the completion of NIV session, the pain intensity level as assessed by visual analogue scale, the morphine and ketamine consumption during NIV sessions, the comparison of blood gas measurements before and after NIV sessions, the reproducibility of NIV cycles. The side effects of DEX will be notified.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Blunt chest trauma with thoracic trauma score\\> 6, ICU admission and spontaneous breathing\n\nExclusion Criteria:\n\n* Contra indication for NIV or Dexmedetomidine as specified by the French marketing authorization'}, 'identificationModule': {'nctId': 'NCT02537366', 'acronym': 'VENDETTA', 'briefTitle': 'Dexmedetomidine for Non-invasive Ventilation After Chest Trauma', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Dexmedetomidine for Non-invasive Ventilation After Chest Trauma (VENDETTA)', 'orgStudyIdInfo': {'id': 'EssaiClinique-VENDETTA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Sodium Chloride 0,9 % Continuous IV infusion begun one hour before NIV session at 0.07 ml/kg/h Adaptation to sedation status by changing infusion speed of 0.02 ml/kg/h every 30 minutes up to 0.14 ml/kg/h Sedation objective Richmond Agitation Sedation Scale -3 (moderate sedation) to 0 (alert and calm)', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'DEX', 'description': 'Dexmedetomidine diluted to 10 µg/ml in Sodium Chloride 0,9 % Continuous IV infusion begun one hour before NIV session at 0.7 µg/kg/h (= 0.07 ml/kg/h) Adaptation to sedation status by changing infusion speed of 0.2 µg/kg/h (= 0.02 ml/kg/h) every 30 minutes up to 1.4 µg/kg/h (= 0.14 ml/kg/h) Sedation objective Richmond Agitation Sedation Scale -3 (moderate sedation) to 0 (alert and calm)', 'interventionNames': ['Drug: Dexmedetomidine']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'armGroupLabels': ['DEX']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'CHU de Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'overallOfficials': [{'name': 'Thibaut TROUVE-BUISSON, PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Grenoble'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}