Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-02-22 @ 9:37 AM
Study NCT ID:
NCT03709394
Status:
COMPLETED
Last Update Posted:
2020-07-21
First Post:
2018-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pre-hospital Ultrasound Guided Peripheral Venous Catheter Insertion
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': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective randomized study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-20', 'studyFirstSubmitDate': '2018-05-08', 'studyFirstSubmitQcDate': '2018-10-12', 'lastUpdatePostDateStruct': {'date': '2020-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of the patients with successful the first cannulation attempt of peripheral venous catheter insertion', 'timeFrame': '60 minutes', 'description': 'Frequency of the patients in which only one cannulation attempt was necessary'}], 'secondaryOutcomes': [{'measure': 'Frequency of the patients with successful peripheral venous catheter insertion irrespective of the number of attempts', 'timeFrame': '60 minutes', 'description': 'Frequency of the patients in which peripheral venous catheter was inserted, irrespective of the number of attempts'}, {'measure': 'The number of attempts required for successful peripheral venous catheter insertion', 'timeFrame': '60 minutes', 'description': 'The number of attempts required for successful peripheral venous catheter insertion'}, {'measure': 'Time required to introduce peripheral venous catheter', 'timeFrame': '60 minutes', 'description': 'Time required to introduce peripheral venous catheter'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ultrasound', 'peripheral venous catheter'], 'conditions': ['Prehospital']}, 'descriptionModule': {'briefSummary': 'This study evaluates two different techniques for ultrasound guided peripheral venous catheter insertion in pre-hospital emergency care in comparison with conventional approach without any ultrasound guidance.', 'detailedDescription': 'Peripheral venous catheter placement is one of the most common interventions in emergency medicine. When performed by conventional approach, the failure of the first attempt occurs up to 22 % and cannulation time exceed 2 minutes in up to 15 %. Ultrasound guidance of peripheral venous catheter (PVC) insertion may improve both. However, this approach has not been verified in the setting of pre-hospital emergency care so far.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Awake patient indicated for peripheral venous catheter placement while treated by emergency medical service\n\nExclusion Criteria:\n\n1. Coma\n2. Age \\<18 years\n3. Patient disagreement with the insertion of peripheral venous catheter\n4. Disagreement of the patient with inclusion in a clinical trial\n5. Contraindication of ultrasound examination of the venous system\n6. Contraindication of the introduction of peripheral venous cannula on both upper limbs\n7. Investigator's opinion that ultrasonic control cannulation would cause undue delay and a other procedure is required"}, 'identificationModule': {'nctId': 'NCT03709394', 'briefTitle': 'Pre-hospital Ultrasound Guided Peripheral Venous Catheter Insertion', 'organization': {'class': 'OTHER', 'fullName': 'Emergency Medical Service of the Central Bohemian Region, Czech Republic'}, 'officialTitle': 'Two Different Techniques for Ultrasound Guided Peripheral Venous Catheter Insertion in Pre-hospital Emergency Care - Randomized Study', 'orgStudyIdInfo': {'id': '2017-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A: Full utrasound guidance', 'description': 'Full utrasound guidance of cathether insertion. Intervention: Ultrasound portable device used for the identification of the target vein and for the ultrasound control of proper catheter placement during the procedure of peripheral venous cannula insertion.', 'interventionNames': ['Procedure: Full utrasound guidance']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B: Partial ultrasound guidance', 'description': 'Catheter insertion under partial ultrasound guidance. Intervention: Ultrasound portable device used only for the identification of the target vein, the catheter placement will be done by conventional approach.', 'interventionNames': ['Procedure: Partial ultrasound guidance']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group C: No ultrasound guidance', 'description': 'Catheter insertion by conventional approach, without ultrasound guidance', 'interventionNames': ['Procedure: No ultrasound guidance']}], 'interventions': [{'name': 'Full utrasound guidance', 'type': 'PROCEDURE', 'description': 'The target vein is directly identified by portable ultrasound device and the complete procedure of peripheral venous cathether insertion is controlled by ultrasound guidance in real time', 'armGroupLabels': ['Group A: Full utrasound guidance']}, {'name': 'Partial ultrasound guidance', 'type': 'PROCEDURE', 'description': 'The target vein is directly identified by ultrasound but the procedure of peripheral venous cathether insertion is performed conventionally, without ultrasound guidance', 'armGroupLabels': ['Group B: Partial ultrasound guidance']}, {'name': 'No ultrasound guidance', 'type': 'PROCEDURE', 'description': 'The target vein is identified and peripheral venous catheter is inserted by conventional approach without use of any guiding devices', 'armGroupLabels': ['Group C: No ultrasound guidance']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beroun', 'state': 'Central Bohemia', 'country': 'Czechia', 'facility': 'Emergency Medical Service of the Central Bohemian Region', 'geoPoint': {'lat': 49.96382, 'lon': 14.072}}], 'overallOfficials': [{'name': 'Roman Skulec, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emergency Medical Service of Central Bohemian Region, Kladno, Czech republic'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR'], 'timeFrame': '1.5.2018, two months', 'ipdSharing': 'YES', 'description': 'Completely anonymous sharing of IPD', 'accessCriteria': 'investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emergency Medical Service of the Central Bohemian Region, Czech Republic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Masaryk Hospital Usti nad Labem', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head physician for science and research', 'investigatorFullName': 'Roman Skulec', 'investigatorAffiliation': 'Emergency Medical Service of the Central Bohemian Region, Czech Republic'}}}}