Ignite Creation Date:
2025-12-24 @ 2:13 PM
Ignite Modification Date:
2026-02-20 @ 1:45 PM
Study NCT ID:
NCT03144895
Status:
UNKNOWN
Last Update Posted:
2018-08-03
First Post:
2017-05-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Arterial Catheterization by Ultrasound
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 380}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2020-03-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-02', 'studyFirstSubmitDate': '2017-05-02', 'studyFirstSubmitQcDate': '2017-05-04', 'lastUpdatePostDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success rate of arterial or femoral catheter placement', 'timeFrame': '1 day', 'description': 'at the first attempted puncture (with only one puncture point on the skin).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ultrasound Therapy; Complications', 'Intensive Care Unit']}, 'referencesModule': {'references': [{'pmid': '34637140', 'type': 'DERIVED', 'citation': 'Flumignan RL, Trevisani VF, Lopes RD, Baptista-Silva JC, Flumignan CD, Nakano LC. Ultrasound guidance for arterial (other than femoral) catheterisation in adults. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD013585. doi: 10.1002/14651858.CD013585.pub2.'}]}, 'descriptionModule': {'briefSummary': 'Monitoring of invasive blood pressure and / or cardiac output of resuscitation patients is required and recommended', 'detailedDescription': 'Monitoring of invasive blood pressure and / or cardiac output of resuscitation patients is required and recommended. The installation of an arterial catheter in intensive care is very frequent and subject to many complications. These complications are now well recognized in the literature, they are mainly vascular, infectious and thrombotic. They are directly influenced by the number of attempts to puncture and the time taken to perform the gesture. Many measures are taken to reduce the impact such as the choice of the site of installation, the strict aseptic techniques during the installation and the type of catheter used. However, despite these measures, it appears that the incidence of these complications remains high. Compared to anatomical marking, only the technique of laying the ultrasound-guided catheter has shown its effectiveness in reducing these complications. The management in intensive care of increasingly complicated, severe, elderly patients with significant comorbidities increases from year to year. To the knowledge of the investigator, there is no study on the impact of ultrasound arterial catheterization in patients in resuscitation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age over 18 years;\n* Hospitalization in resuscitation;\n* Necessity of installation of an arterial catheter\n* Signed informed consent.\n* Affiliation to a social security scheme\n\nExclusion Criteria:\n\n* Patient under tutorship or curatorship\n* Minor Patient'}, 'identificationModule': {'nctId': 'NCT03144895', 'acronym': 'ACTIVE', 'briefTitle': 'Arterial Catheterization by Ultrasound', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Arterial Catheterization by Ultrasound: Impact on Success Rates and Complications in Patients Hospitalized in Resuscitation', 'orgStudyIdInfo': {'id': 'PI2016_843_0014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Arterial catheter', 'description': 'by anatomical placement alone', 'interventionNames': ['Procedure: Laying a radial or femoral arterial catheter']}, {'type': 'OTHER', 'label': 'Placement', 'description': 'of an arterial catheter by ultrasound tracking', 'interventionNames': ['Procedure: Laying a radial or femoral arterial catheter']}], 'interventions': [{'name': 'Laying a radial or femoral arterial catheter', 'type': 'PROCEDURE', 'description': 'Laying a radial or femoral arterial catheter', 'armGroupLabels': ['Arterial catheter', 'Placement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'state': 'Picardie', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Elie ZOGHEIB, PhD', 'role': 'CONTACT', 'email': 'zogheib.elie@chu-amiens.fr', 'phone': '+33322087832'}], 'facility': 'CHU Amiens Picardie', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}], 'centralContacts': [{'name': 'Elie ZOGHEIB, PhD', 'role': 'CONTACT', 'email': 'zogheib.elie@chu-amiens.fr', 'phone': '+33322087832'}], 'overallOfficials': [{'name': 'Elie ZOGHEIB, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU AMIENS-PICARDIE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}