Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2026-01-04 @ 6:30 AM
Study NCT ID:
NCT02918604
Status:
COMPLETED
Last Update Posted:
2016-09-29
First Post:
2016-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pediatric Veins Cannulation Technique
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'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-27', 'studyFirstSubmitDate': '2016-09-20', 'studyFirstSubmitQcDate': '2016-09-27', 'lastUpdatePostDateStruct': {'date': '2016-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'success of peripheral vein access positioning', 'timeFrame': '2 year', 'description': 'to determine the success rate at first attempt of peripheral veins cannulation in small children (\\<5yrs) and infants (\\<1yr) of Veinsite compared with traditional palpation method performed by skilled operators.'}], 'secondaryOutcomes': [{'measure': 'impact of DIVA score(difficult vein access score) on time of success number of participants with treatment-related peripheral vein cannulation failure', 'timeFrame': '2 year', 'description': "of this study is to determine the time to cannulation using the two techniques, the difference in visualized veins using the Veinsite or the direct visualization and palpation of the patients' skin, cannula indwelling time and complications related to the procedure."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['peripheral vein access', 'infrared', 'pediatric'], 'conditions': ['Successful Vein Cannulation at First Attempt']}, 'referencesModule': {'references': [{'pmid': '22267855', 'type': 'BACKGROUND', 'citation': "Reigart JR, Chamberlain KH, Eldridge D, O'Brien ES, Freeland KD, Larsen P, Goff D, Hartzog TH. Peripheral intravenous access in pediatric inpatients. Clin Pediatr (Phila). 2012 May;51(5):468-72. doi: 10.1177/0009922811435164. Epub 2012 Jan 20."}, {'pmid': '21854488', 'type': 'BACKGROUND', 'citation': 'Chapman LL, Sullivan B, Pacheco AL, Draleau CP, Becker BM. VeinViewer-assisted Intravenous catheter placement in a pediatric emergency department. Acad Emerg Med. 2011 Sep;18(9):966-71. doi: 10.1111/j.1553-2712.2011.01155.x. Epub 2011 Aug 19.'}, {'pmid': '22415409', 'type': 'BACKGROUND', 'citation': 'Kim MJ, Park JM, Rhee N, Je SM, Hong SH, Lee YM, Chung SP, Kim SH. Efficacy of VeinViewer in pediatric peripheral intravenous access: a randomized controlled trial. Eur J Pediatr. 2012 Jul;171(7):1121-5. doi: 10.1007/s00431-012-1713-9. Epub 2012 Mar 14.'}, {'pmid': '18347490', 'type': 'BACKGROUND', 'citation': 'Yen K, Riegert A, Gorelick MH. Derivation of the DIVA score: a clinical prediction rule for the identification of children with difficult intravenous access. Pediatr Emerg Care. 2008 Mar;24(3):143-7. doi: 10.1097/PEC.0b013e3181666f32.'}]}, 'descriptionModule': {'briefSummary': 'multicenter, prospective and cohort study to evaluate infrared technology for identifying and and indwelling peripheral veins in 0 up to 4 years old children.', 'detailedDescription': 'AIM OF THE STUDY The primary objective of this study is to determine the success rate at first attempt of peripheral veins cannulation in small children (\\<5yrs) and infants (\\<1yr) of Veinsite compared with traditional palpation method performed by skilled operators.\n\nThe secondary objective of this study is to determine the time to cannulation using the two techniques, the difference in visualized veins using the Veinsite or the direct visualization and palpation of the patients\' skin, cannula indwelling time and complications related to the procedure.\n\nDESIGN Prospective randomized controlled study\n\nPopulation\n\nIt is expected to recruit 60 pediatric patients undergoing peripheral vein cannulation with known difficulties according the difficult venous access score (DIVA) (6) in the following centers:\n\n1. Fondazione IRCCS Istituto Neurologico "C.Besta" , Milano\n2. Ospedale Pediatrico Bambino Gesù, IRCCS, Roma\n\nDuration of study Patient will be followed from the day of peripheral vein cannulation till the peripheral cannula will be removed (max 3 days) in order to assess any cause of venous extravasation. The recruitment phase is supposed to be 6 months after achieving the ethical-administrative authorization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and Female children from 1 month to 5 years Of age\n* American Society of Anesthesiologists Classification (ASA) I: without systemic disease\n* American Society of Anesthesiologists Classification (ASA) II: moderate systemic disease\n* American Society of Anesthesiologists Classification (ASA) III: severe systemic disease that limits normal activity, without invalidity.\n* Scheduled for any indication of peripheral venous line placement\n* Admission to an Intensive Care Unit, Neurosurgery ward or pediatric ward of one of the hospitals included\n* Children whose parents (or legal tutors) have given their informed written consent\n\nExclusion Criteria:\n\n* Any contraindication for peripheral line placement\n* Children whose parents (or legal tutors) denied their own consensus'}, 'identificationModule': {'nctId': 'NCT02918604', 'briefTitle': 'Pediatric Veins Cannulation Technique', 'organization': {'class': 'OTHER', 'fullName': 'Bambino Gesù Hospital and Research Institute'}, 'officialTitle': 'Peripheral Veins Cannulation in Children Using Veinsite: a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'AR-INNCB 11-2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'B : veinsite access', 'description': 'infrared technology vein access', 'interventionNames': ['Device: infrared technology: Veinsite']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'A: control group', 'description': 'conventional vein access', 'interventionNames': ['Device: infrared technology: Veinsite']}], 'interventions': [{'name': 'infrared technology: Veinsite', 'type': 'DEVICE', 'description': 'peripheral vein access performed with Veinsite support by expert paediatric anaesthesiologists and intensivists', 'armGroupLabels': ['A: control group', 'B : veinsite access']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bambino Gesù Hospital and Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Emanuele Rossetti', 'investigatorAffiliation': 'Bambino Gesù Hospital and Research Institute'}}}}