Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2025-12-30 @ 7:05 AM
Study NCT ID:
NCT05242068
Status:
COMPLETED
Last Update Posted:
2022-02-16
First Post:
2022-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Can Veinlite Reduce Complications of Peripheral Intravenous Catheter Placement in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study was a prospective randomized controlled clinical study of children treated in a pediatric surgical ward who required PIC. The aim of the research was to evaluate whether the Veinlite would prevent catheter-related complications'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 139}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2020-01-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-05', 'studyFirstSubmitDate': '2022-01-26', 'studyFirstSubmitQcDate': '2022-02-05', 'lastUpdatePostDateStruct': {'date': '2022-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reducing number of complications related with peripheral intravenous catheter', 'timeFrame': 'Duration of catheter dwell time (up to 168 hours)', 'description': 'Reducing number of complications related with peripheral intravenous catheter during treatment'}], 'secondaryOutcomes': [{'measure': 'Pain scores during peripheral intravenous catheterization', 'timeFrame': 'Immediately after IV placement', 'description': 'Pain scores by child, nurse, and parent. In this study, numerical rating score was used for determine pain level. The numeric rating scale is one of the most commonly used to obtain self-reports of pain intensity in school-age children, adolescents, and adults. The numerical rating scale (NRS) requires the child to rate her/his pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable.'}, {'measure': 'Catheter dwell time', 'timeFrame': 'Up to 168 hours (1 week)', 'description': 'Intravenous catheter survival time during the treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pain', 'children', 'vein imaging device', 'intravenous complications'], 'conditions': ['Catheterization', 'Pain', 'Complication']}, 'descriptionModule': {'briefSummary': "This study was conducted to investigate the use of Veinlite LED+ (TransLite, Sugar Land, Tex) to assist with PIC placement. The Veinlite uses LED (light-emitting diode) lights to enhance the visualization of veins by using orange and red color that are absorbed in venous blood.\n\nThe investigators' hypothesis for this study was that the vein imaging would reduce the complications related to catheter and the pain that the participants would feel.", 'detailedDescription': 'Peripheral Intravenous Catheterization (PIC) introduces multiple risks and potential morbidities. Patients with PIC-associated complications have longer length of stay, higher clinical and economic burden, and greater risk of death than patients without. The most serious complications due to intravenous (IV) catheters are infiltration and extravasation.\n\nThe primary endpoint was to evaluate whether Veinlite LED+ would prevent catheter-related complications.\n\nThe secondary endpoint were;\n\n1. to evaluate the efficacy of the vein imaging device on pediatric pain during intravenous catheterization\n2. to evaluate the efficacy of the vein imaging device on catheter dwell time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '5 Years', 'genderBased': True, 'genderDescription': 'Children in both the Standard care of group and Veinlite group were to be stratified into three age groups: 5 to 9, 10 to 14 and 15 to 18', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged between 5 and 18\n* Children with DIVA (Difficult intravenous access score) score 4 or more\n* That the child and the parent speak Turkish\n\nExclusion Criteria:\n\n* needing urgent treatment\n* a critical health condition\n* That the child or the parent has a communication problem'}, 'identificationModule': {'nctId': 'NCT05242068', 'briefTitle': 'Can Veinlite Reduce Complications of Peripheral Intravenous Catheter Placement in Children', 'organization': {'class': 'OTHER', 'fullName': 'Ege University'}, 'officialTitle': 'Can Veinlite Reduce Complications of Peripheral Intravenous Catheter Placement in Children: Preliminary Results.', 'orgStudyIdInfo': {'id': 'E.314064'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Standard care of group', 'description': 'Patients in standard care of group received traditional peripheral intravenous catheterization', 'interventionNames': ['Other: Standard care']}, {'type': 'EXPERIMENTAL', 'label': 'Veinlite group', 'description': 'Patients in veinlite group received peripheral intravenous catheterization with Veinlite', 'interventionNames': ['Device: Veinlite']}], 'interventions': [{'name': 'Veinlite', 'type': 'DEVICE', 'description': 'Use of vein imaging device for visualization of veins during peripheral IV placement', 'armGroupLabels': ['Veinlite group']}, {'name': 'Standard care', 'type': 'OTHER', 'description': 'Patients received standard intravenous catheterization.', 'armGroupLabels': ['Standard care of group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Ege University', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ege University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Ayşe Kahraman', 'investigatorAffiliation': 'Ege University'}}}}