Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2026-01-07 @ 6:58 AM
Study NCT ID:
NCT06422195
Status:
COMPLETED
Last Update Posted:
2025-04-10
First Post:
2024-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dynamic Needle Tip Positioning Modification Technique in Short Axis Approach
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 164}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-09', 'studyFirstSubmitDate': '2024-05-14', 'studyFirstSubmitQcDate': '2024-05-18', 'lastUpdatePostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to achieve successful cannulation', 'timeFrame': 'Immediately after catheterization', 'description': 'Time to achieve successful cannulation will be measured from initial skin puncture until the catheter is placed into the radial artery.'}], 'secondaryOutcomes': [{'measure': 'The success rate', 'timeFrame': 'Immediately after catheterization', 'description': 'The success rate in the first trial of insertion between the two different approaches will be assessed.'}, {'measure': 'Number of attempts till successful arterial cannula insertion', 'timeFrame': 'Immediately after catheterization', 'description': 'Number of attempts till successful arterial cannula insertion will be recorded.'}, {'measure': 'Incidence of complications', 'timeFrame': '24 hours postoperatively', 'description': 'Complications including edema, hematoma, vasospasm, ischemia, thrombosis and nerve injury will be recorded.'}, {'measure': "Operators' satisfaction", 'timeFrame': 'Immediately after catheterization', 'description': "Operators' satisfaction (Level of operators' satisfaction will be assessed with a Scale from 1-5)"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dynamic Needle Tip Positioning', 'Short Axis', 'Arterial Cannulation', 'Long Axis']}, 'referencesModule': {'references': [{'pmid': '41239242', 'type': 'DERIVED', 'citation': 'Elmazny MI, Ahmed S, Afifi S. Dynamic needle tip positioning in short-axis versus long-axis ultrasound-guided arterial cannulation: a randomised controlled trial. BMC Anesthesiol. 2025 Nov 14;25(1):561. doi: 10.1186/s12871-025-03413-3.'}]}, 'descriptionModule': {'briefSummary': "The aim of the present study is to compare between Dynamic Needle Tip Positioning Modification Technique in Short Axis Approach (DNTP - SA) and Long Axis (LA) Approach for Ultrasound-guided Arterial Cannulation as regard time to successful arterial cannula insertion as well as the success rate in the first trial of insertion, number of attempts till successful arterial line placemen, complications, and operators' satisfaction.", 'detailedDescription': 'Intraoperative Arterial cannulation is recently frequently required especially in high-risk patients or patients with expected major fluid shift.\n\nThe most common site for arterial cannulation is the radial artery because of ease of accessibility, dual blood supply to the hand via the ulnar artery, and a low rate of complications. Complications from arterial cannulation include thrombosis, hematoma formation, edema and vasospasm.\n\nTwo approaches are basically identified for ultrasound-guided radial artery cannulation, i.e., short-axis out-of-plane (SA-OOP) and long-axis in-plane (LA-IP) techniques.\n\nThe dynamic needle tip positioning (DNTP) technique uses the short-axis view of the radial artery with gradual advancing of the needle till reaching the radial artery. Meanwhile, the ultrasound probe is being moved proximally in advance of the needle tip until it disappears from the ultrasound image. The cannula then advanced in the direction of the artery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 70 years.\n* Both sexes.\n* American Society of Anesthesiologists physical status II-IV.\n* Patients scheduled for elective surgery procedure that requires the use of invasive arterial pressure monitoring, as determined by the attending anesthesiologist.\n\nExclusion Criteria:\n\n* Emergency patients or with Hemodynamic instability.\n* Patients who have cellulitis or infection at the site of insertion.\n* Patients with a positive modified Allen test.\n* Raynaud disease or any Peripheral vascular disease.\n* Patients with Multiple previous radial artery interventional therapies in the previous 30 days.\n* Patients scheduled for Surgery at site of insertion like forearm flap.\n* Refusal to participate by the patient.'}, 'identificationModule': {'nctId': 'NCT06422195', 'briefTitle': 'Dynamic Needle Tip Positioning Modification Technique in Short Axis Approach', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Does the Dynamic Needle Tip Positioning Modification Technique in Short Axis Approach (DNTP - SA) Provides a Faster Ultrasound-guided Arterial Cannulation Than Long Axis (LA) Approach: A Prospective Randomized Controlled Study', 'orgStudyIdInfo': {'id': '36197/12/22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dynamic Needle Tip Positioning Technique in Short Axis Approach (DNTP - SA)', 'description': 'Ultrasound guided radial artery cannulation by Dynamic Needle Tip Positioning Technique in Short Axis Approach (DNTP - SA) will be performed by an experienced anesthesiologist who has no subsequent role in the study. The ultrasound transducer is oriented transversely to the radial artery at the wrist, and the vessel appears as a circular anechoic structure in the ultrasound screen with gradual advancing of the needle till reaching the radial artery. Meanwhile, the ultrasound probe is being moved proximally in advance of the needle tip until it disappears from the ultrasound image. The cannula then advanced in the direction of the artery.', 'interventionNames': ['Other: Dynamic Needle Tip Positioning Technique in Short Axis Approach (DNTP - SA)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Long Axis Approach (LA)', 'description': 'Ultrasound guided radial artery cannulation in Long Axis Approach (LA) will be performed by an experienced anesthesiologist who has no subsequent role in the study. In the LA-IP approach, an ultrasound probe is placed parallel to the radial artery and the artery appears as a tubular anechoic structure in ultrasound.', 'interventionNames': ['Other: Long Axis Approach (LA)']}], 'interventions': [{'name': 'Dynamic Needle Tip Positioning Technique in Short Axis Approach (DNTP - SA)', 'type': 'OTHER', 'description': 'Ultrasound guided radial artery cannulation by Dynamic Needle Tip Positioning Technique in Short Axis Approach (DNTP - SA) will be performed by an experienced anesthesiologist who has no subsequent role in the study. The ultrasound transducer is oriented transversely to the radial artery at the wrist, and the vessel appears as a circular anechoic structure in the ultrasound screen with gradual advancing of the needle till reaching the radial artery. Meanwhile, the ultrasound probe is being moved proximally in advance of the needle tip until it disappears from the ultrasound image. The cannula then advanced in the direction of the artery.', 'armGroupLabels': ['Dynamic Needle Tip Positioning Technique in Short Axis Approach (DNTP - SA)']}, {'name': 'Long Axis Approach (LA)', 'type': 'OTHER', 'description': 'Ultrasound guided radial artery cannulation in Long Axis Approach (LA) will be performed by an experienced anesthesiologist who has no subsequent role in the study. In the LA-IP approach, an ultrasound probe is placed parallel to the radial artery and the artery appears as a tubular anechoic structure in ultrasound.', 'armGroupLabels': ['Long Axis Approach (LA)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'state': 'El-Gharbia', 'country': 'Egypt', 'facility': 'Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.', 'investigatorFullName': 'Maram Ibrahim Elmazny', 'investigatorAffiliation': 'Tanta University'}}}}