Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2026-02-25 @ 8:30 PM
Study NCT ID:
NCT04265703
Status:
COMPLETED
Last Update Posted:
2025-09-25
First Post:
2020-02-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The INVADE Study: INnominate Vein Approach for Central Catheterization in Difficult to cannulatE Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 308}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-21', 'studyFirstSubmitDate': '2020-02-09', 'studyFirstSubmitQcDate': '2020-02-09', 'lastUpdatePostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cannulation failure rate', 'timeFrame': 'Baseline', 'description': 'Failure to cannulate selected vein at first attempt'}], 'secondaryOutcomes': [{'measure': 'Central line-associated blood infection rate', 'timeFrame': '28 days', 'description': 'Confirmed with blood cultures'}, {'measure': 'Collapsibility associated with failure', 'timeFrame': 'Baseline', 'description': 'Percentage of vein collapsibility independently associated with cannulation failure'}, {'measure': 'Cannulation number of attempts', 'timeFrame': 'Baseline', 'description': 'Number of attempts needed to attain cannulation'}, {'measure': 'Procedure time', 'timeFrame': 'Baseline', 'description': 'Time from skin puncture to guidewire confirmed into vessel (minutes)'}, {'measure': 'Arterial puncture rate', 'timeFrame': 'Baseline', 'description': 'Confirmed immediately after procedure with vascular ultrasound'}, {'measure': 'Hematoma formation rate', 'timeFrame': '7 days', 'description': 'Confirmed immediately after procedure with vascular ultrasound'}, {'measure': 'Neumothorax rate', 'timeFrame': '7 days', 'description': 'Confirmed immediately after procedure with lung ultrasound'}, {'measure': 'Hemothorax rate', 'timeFrame': '7 days', 'description': 'Confirmed immediately after procedure with lung ultrasound'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Central venous access', 'Ultrasound-guided catheterization', 'Innominate vein', 'Brachiocephalic vein'], 'conditions': ['Critical Illness']}, 'descriptionModule': {'briefSummary': 'Most recent guidelines suggest central venous access must be performed with real-time ultrasound guidance, and the most recommended site for cannulation is internal jugular vein (IJV); however, it is recognized that evidence for other sites is, at present, limited. Besides, guidelines does not account for patients with small vein cross-sectional area and/or respirophasic collapse, which can make the procedure more difficult or even impossible. The investigators aim to compare three different insertion sites for central venous access, with real-time ultrasound guidance', 'detailedDescription': 'Ultrasound-guided cannulation of central veins is successful in \\>95% of the cases, according to the largest study so far. However, this and other studies with similar success rate, are performed in patients with general anesthesia and/or neuromuscular blockade, without spontaneous respiratory efforts. Critical care physicians and many other specialists frequently need to cannulate patients in special circumstances as hypovolemia, pain, anxiety, and respiratory efforts that promotes respirophasic variation in cross-sectional area, and even complete collapse of the vessel. These changes can increase the probability of posterior wall or arterial puncture, hematomas, pneumothorax, etc. Supraclavicular approach for cannulation of the subclavian vein is a method described since 1965, also giving direct access to the innominate vein, a larger vessel which is rarely collapsible regardless of volume status or respiratory efforts. Based on a previous pilot trial, in this multi-center, prospective, randomized, controlled trial, the investigators aim to compare the successfulness and safety of ultrasound-guided central venous cannulation at 3 different sites: internal jugular, subclavian, and innominate veins.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who need central venous catheterization, and have respirophasic variation in cross-sectional area of jugular veins\n\nExclusion Criteria:\n\n* Less than 18 years-old\n\n * Patients with previous failed attempts with non-ultrasound guided technique\n * Non-resolved pneumothorax/hemothorax at enrollment\n * Refusal to sign informed consent'}, 'identificationModule': {'nctId': 'NCT04265703', 'acronym': 'INVADE', 'briefTitle': 'The INVADE Study: INnominate Vein Approach for Central Catheterization in Difficult to cannulatE Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Civil de Guadalajara'}, 'officialTitle': 'Central Venous Access in Patients With Difficult Cannulation, A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'HCG/CEI-1196/19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Internal jugular vein site', 'description': 'Ultrasound-guided central venous catheterization at internal jugular vein site', 'interventionNames': ['Procedure: Internal jugular vein catheterization']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Subclavian vein site', 'description': 'Ultrasound-guided central venous catheterization at subclavian vein site', 'interventionNames': ['Procedure: Subclavian vein catheterization']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Innominate vein site', 'description': 'Ultrasound-guided central venous catheterization at innominate vein site', 'interventionNames': ['Procedure: Innominate vein catheterization']}], 'interventions': [{'name': 'Internal jugular vein catheterization', 'type': 'PROCEDURE', 'description': 'Catheterization of internal jugular vein with real-time (in-plane) method, with neutral neck position. Standard aseptic technique.', 'armGroupLabels': ['Internal jugular vein site']}, {'name': 'Subclavian vein catheterization', 'type': 'PROCEDURE', 'description': 'Catheterization of subclavian/axillary vein with infra-clavicular approach with real-time (in-plane) method, without shoulder retraction. Standard aseptic technique.', 'armGroupLabels': ['Subclavian vein site']}, {'name': 'Innominate vein catheterization', 'type': 'PROCEDURE', 'description': 'Catheterization of innominate vein with supra-clavicular approach with real-time (in-plane) method, with neutral shoulder position and no shoulder retraction. Standard aseptic technique.', 'armGroupLabels': ['Innominate vein site']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44280', 'city': 'Guadalajara', 'country': 'Mexico', 'facility': 'Hospital Civil Fray Antonio Alcalde', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}], 'overallOfficials': [{'name': 'Miguel Ibarra-Estrada, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Civil Fray Antonio Alcalde'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Civil de Guadalajara', 'class': 'OTHER'}, 'collaborators': [{'name': 'Instituto Jalisciense de Cancerologia', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Miguel Á Ibarra-Estrada', 'investigatorAffiliation': 'Hospital Civil de Guadalajara'}}}}