Ignite Creation Date:
2025-12-24 @ 12:00 PM
Ignite Modification Date:
2025-12-27 @ 10:03 PM
Study NCT ID:
NCT05443061
Status:
COMPLETED
Last Update Posted:
2025-04-29
First Post:
2022-06-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Subcutaneous Nitroglycerin to Prevent Radial Artery Occlusion in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007511', 'term': 'Ischemia'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005996', 'term': 'Nitroglycerin'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-24', 'studyFirstSubmitDate': '2022-06-29', 'studyFirstSubmitQcDate': '2022-06-29', 'lastUpdatePostDateStruct': {'date': '2025-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of radial arterial occlusion (RAO) (%)', 'timeFrame': 'After removal of the radial artery catheter (up to 24 hour)', 'description': 'RAO is defined as no pulse oximeter wave at the index finger during compression of the ipsilateral ulnar artery.'}], 'secondaryOutcomes': [{'measure': 'First attempt success rate (%)', 'timeFrame': 'During radial artery cannulation (up to 1 hour)', 'description': 'Success at the first skin puncture'}, {'measure': 'Size of radial artery (mm)', 'timeFrame': 'Before and after subcutaneous injection of drugs / Before and after catheterization / Before and after removal of the catheter (up to 1 hour)', 'description': 'Internal diameter of radial artery'}, {'measure': 'depth of radial artery (mm)', 'timeFrame': 'Before and after subcutaneous injection of drugs / Before and after catheterization / Before and after removal of the catheter (up to 1 hour)', 'description': 'depth of radial artery from the skin'}, {'measure': 'flow velocity of the radial artery (cm/s)', 'timeFrame': 'Before and after subcutaneous injection of drugs / Before and after catheterization / Before and after removal of the catheter (up to 1 hour)', 'description': 'flow velocity of the radial artery measured by Doppler ultrasound'}, {'measure': 'Perfusion index', 'timeFrame': 'Before and after subcutaneous injection of drugs / Before and after catheterization / Before and after removal of the catheter (up to 1 hour)', 'description': 'Perfusion index measured by pulse oximeter sensor at the distally located index finger of radial arterial catheterization'}, {'measure': 'Overall attempt (number)', 'timeFrame': 'During radial artery cannulation (up to 1 hour)', 'description': 'Number of attempt of radial artery cannulation'}, {'measure': 'Overall Procedure time (seconds)', 'timeFrame': 'During radial artery cannulation (up to 1 hour)', 'description': 'From ultrasound guidance, to Arterial waveform'}, {'measure': 'Overall success rate (%)', 'timeFrame': 'During radial artery cannulation (up to 1 hour)', 'description': 'Success within 2 skin puncture and within 10 minutes'}, {'measure': 'Incidence of posterior wall puncture (%)', 'timeFrame': 'During radial artery cannulation (up to 1 hour)', 'description': 'Incidence of posterior wall (transfixation technique) puncture during radial arterial catherization'}, {'measure': 'Number of arteries cannulated', 'timeFrame': 'During radial artery cannulation (up to 1 hour)', 'description': 'Number of arteries cannulated for peripheral arterial catheterization'}, {'measure': 'Malfunction of radial artery catheter', 'timeFrame': 'After radial artery cannulation assessed during anesthesia (per 24hour, up to 480 hour)', 'description': 'Invasive blood pressure monitoring, Sampling (%)'}, {'measure': 'Complication rate', 'timeFrame': 'After radial artery cannulation assessed up to PACU, PICU stay (per 24hour, up to 480 hour)', 'description': 'Hematoma, Distal ischemia, Spasm accessed by ultrasound (%)'}, {'measure': 'Duration of radial arterial catherization', 'timeFrame': 'After radial artery cannulation assessed during anesthesia (up to 480 hour)', 'description': 'Duration of radial arterial catherization (hours, minutes)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Radial Artery', 'Vascular Catheters'], 'conditions': ['Arterial Line', 'Ischemia']}, 'referencesModule': {'references': [{'pmid': '32282432', 'type': 'BACKGROUND', 'citation': 'Jang YE, Ji SH, Kim EH, Lee JH, Kim HS, Mossad EB, Kim JT. Subcutaneous Nitroglycerin for Radial Arterial Catheterization in Pediatric Patients: A Randomized Controlled Trial. Anesthesiology. 2020 Jul;133(1):53-63. doi: 10.1097/ALN.0000000000003308.'}, {'pmid': '34352073', 'type': 'BACKGROUND', 'citation': 'Jang YE, Cho SA, Ji SH, Kim EH, Lee JH, Kim HS, Kim JT. Smart Glasses for Radial Arterial Catheterization in Pediatric Patients: A Randomized Clinical Trial. Anesthesiology. 2021 Oct 1;135(4):612-620. doi: 10.1097/ALN.0000000000003914.'}, {'pmid': '31356376', 'type': 'BACKGROUND', 'citation': 'Jang YE, Kim EH, Lee JH, Kim HS, Kim JT. Guidewire-assisted vs. direct radial arterial cannulation in neonates and infants: A randomised controlled trial. Eur J Anaesthesiol. 2019 Oct;36(10):738-744. doi: 10.1097/EJA.0000000000001064.'}, {'pmid': '28682811', 'type': 'BACKGROUND', 'citation': 'Kim EH, Lee JH, Song IK, Kim JT, Lee WJ, Kim HS. Posterior Tibial Artery as an Alternative to the Radial Artery for Arterial Cannulation Site in Small Children: A Randomized Controlled Study. Anesthesiology. 2017 Sep;127(3):423-431. doi: 10.1097/ALN.0000000000001774.'}, {'pmid': '41051743', 'type': 'DERIVED', 'citation': 'Park JB, Ji SH, Kim EH, Lee JH, Kim HS, Kim JT, Jang YE. Subcutaneous Nitroglycerin to Prevent Radial Artery Occlusion in Pediatric Patients: A Randomized Clinical Trial. JAMA Pediatr. 2025 Dec 1;179(12):1283-1290. doi: 10.1001/jamapediatrics.2025.3652.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to evaluate the vasodilative effect of subcutaneous nitroglycerin to prevent radial arterial occlusion(RAO) after removal of the radial arterial catheter in pediatric patients. The hypothesis of this study is that subcutaneous nitroglycerin will decrease the incidence of radial arterial occlusion after radial arterial catheter removal in pediatric patients by increasing the radial artery size. This is a single-center, double-blind, randomized, placebo-controlled study comparing the effect of subcutaneous nitroglycerin and saline on radial artery cannulation and catheter removal in pediatric patients. Prior to the procedure, each patient will be randomized into either the control arm, saline, or the study arm, nitroglycerin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing General anesthesia\n* Patients in the Intensive care unit\n* Arterial cannulation for hemodynamic monitoring, or multiple blood sample\n\nExclusion Criteria:\n\n* Unstable vital signs, significant arrhythmia or hypotension, Shock\n* High risk of peripheral ischemia\n* Skin disease, infection, hematoma, recent cannulation at the radial artery\n* History of anaphylaxis to nitroglycerin'}, 'identificationModule': {'nctId': 'NCT05443061', 'briefTitle': 'Subcutaneous Nitroglycerin to Prevent Radial Artery Occlusion in Children', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Effect of Subcutaneous Nitroglycerin on the Prevention of Radial Artery Occlusion After Radial Artery Catheterization in Pediatric Patients - a Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'H-2206-070-1332'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nitroglycerin', 'description': 'Nitroglycerin 5mcg/kg (in 0.5cc) is subcutaneously injected before radial artery cannulation and before removal of the radial arterial catheter.', 'interventionNames': ['Drug: Nitroglycerin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Normal saline (0.5cc) is subcutaneously injected before radial artery cannulation and before removal of the radial arterial catheter.', 'interventionNames': ['Drug: Normal saline']}], 'interventions': [{'name': 'Nitroglycerin', 'type': 'DRUG', 'description': 'Subcutaneous nitroglycerin injection to decrease the incidence of radial arterial occlusion after arterial catheter removal in pediatric patients.', 'armGroupLabels': ['Nitroglycerin']}, {'name': 'Normal saline', 'type': 'DRUG', 'description': 'Subcutaneous normal saline injection to decrease the incidence of radial arterial occlusion after arterial catheter removal in pediatric patients.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Young-Eun Jang, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical assistant professor, Department of anesthesiology and pain medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical assistant professor', 'investigatorFullName': 'Young-Eun Jang', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}