Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-31 @ 3:43 PM
Study NCT ID:
NCT03134560
Status:
COMPLETED
Last Update Posted:
2017-10-30
First Post:
2017-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravenous Cannulation Using Vein Display Instrument and Without Using Vein Display Instrument in Pediatric Patients
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': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-26', 'studyFirstSubmitDate': '2017-04-24', 'studyFirstSubmitQcDate': '2017-04-26', 'lastUpdatePostDateStruct': {'date': '2017-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful first vein cannulation attempt', 'timeFrame': 'Day 1', 'description': 'Whether the first vein cannulation attempt successful or not will be recorded'}]}, 'conditionsModule': {'keywords': ['vein display instrument', 'pediatric', 'vein access', 'vein cannulation'], 'conditions': ['Difficult Vein Access']}, 'referencesModule': {'availIpds': [{'url': 'https://books.google.co.id/books/about/Pediatric_Anesthesia.html?id=RYe4GBD6LrQC&redir_esc=y', 'type': 'Textbook', 'comment': "Hannallah RS , Verghese ST. Peripheral vascular access. In: Bissonnette B, Anderson BJ, Bosenberg A, Engelhardt T, Mason LJ, Tobias JD, editors. Pediatric Anesthesia. Connecticut: People's Medical Publishing House USA, 2011.p. 1097-102."}], 'references': [{'pmid': '23952007', 'type': 'BACKGROUND', 'citation': 'Myers LA, Arteaga GM, Kolb LJ, Lohse CM, Russi CS. Prehospital peripheral intravenous vascular access success rates in children. Prehosp Emerg Care. 2013 Oct-Dec;17(4):425-8. doi: 10.3109/10903127.2013.818180. Epub 2013 Aug 16.'}, {'pmid': '16134420', 'type': 'BACKGROUND', 'citation': 'Scales K. Vascular access: a guide to peripheral venous cannulation. Nurs Stand. 2005 Aug 17-23;19(49):48-52. doi: 10.7748/ns2005.08.19.49.48.c3935.'}, {'pmid': '19262420', 'type': 'BACKGROUND', 'citation': 'Doniger SJ, Ishimine P, Fox JC, Kanegaye JT. Randomized controlled trial of ultrasound-guided peripheral intravenous catheter placement versus traditional techniques in difficult-access pediatric patients. Pediatr Emerg Care. 2009 Mar;25(3):154-9. doi: 10.1097/PEC.0b013e31819a8946.'}, {'pmid': '18931210', 'type': 'BACKGROUND', 'citation': 'Simhi E, Kachko L, Bruckheimer E, Katz J. A vein entry indicator device for facilitating peripheral intravenous cannulation in children: a prospective, randomized, controlled trial. Anesth Analg. 2008 Nov;107(5):1531-5. doi: 10.1213/ane.0b013e318185cdab.'}, {'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': '22967159', 'type': 'BACKGROUND', 'citation': 'Schindler E, Schears GJ, Hall SR, Yamamoto T. Ultrasound for vascular access in pediatric patients. Paediatr Anaesth. 2012 Oct;22(10):1002-7. doi: 10.1111/pan.12005.'}, {'pmid': '16538464', 'type': 'BACKGROUND', 'citation': 'Donaldson JS. Pediatric vascular access. Pediatr Radiol. 2006 May;36(5):386-97. doi: 10.1007/s00247-006-0118-1. Epub 2006 Mar 15.'}, {'pmid': '23258720', 'type': 'BACKGROUND', 'citation': 'de Negri DC, Avelar AF, Andreoni S, Pedreira Mda L. Predisposing factors for peripheral intravenous puncture failure in children. Rev Lat Am Enfermagem. 2012 Nov-Dec;20(6):1072-80. doi: 10.1590/s0104-11692012000600009. English, Portuguese, Spanish.'}, {'pmid': '23687310', 'type': 'BACKGROUND', 'citation': 'Lamperti M, Pittiruti M. II. Difficult peripheral veins: turn on the lights. Br J Anaesth. 2013 Jun;110(6):888-91. doi: 10.1093/bja/aet078. No abstract available.'}, {'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': '23384732', 'type': 'BACKGROUND', 'citation': 'Chiao FB, Resta-Flarer F, Lesser J, Ng J, Ganz A, Pino-Luey D, Bennett H, Perkins C Jr, Witek B. Vein visualization: patient characteristic factors and efficacy of a new infrared vein finder technology. Br J Anaesth. 2013 Jun;110(6):966-71. doi: 10.1093/bja/aet003. Epub 2013 Feb 5.'}, {'pmid': '22694242', 'type': 'BACKGROUND', 'citation': 'Kaddoum RN, Anghelescu DL, Parish ME, Wright BB, Trujillo L, Wu J, Wu Y, Burgoyne LL. A randomized controlled trial comparing the AccuVein AV300 device to standard insertion technique for intravenous cannulation of anesthetized children. Paediatr Anaesth. 2012 Sep;22(9):884-9. doi: 10.1111/j.1460-9592.2012.03896.x. Epub 2012 Jun 14.'}, {'pmid': '17238901', 'type': 'BACKGROUND', 'citation': 'John JM. Transillumination for vascular access: old concept, new technology. Paediatr Anaesth. 2007 Feb;17(2):197-8. doi: 10.1111/j.1460-9592.2006.02061.x. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to compare intravenous cannulation success rate between using vein display instrument and without using vein display instrument in pediatric patients.', 'detailedDescription': "Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Parents' subjects were given informed consent before enrolling the study. After doing asepsis and antisepsis procedure and putting on the tourniquet the first group would get intravenous cannulation without vein displaying instrument. While for the second group, after doing asepsis procedure and tourniquet was put on, a vein display instrument was used to choose the vein. Intravenous cannulation was done after antiseptic procedure. After blood dripped out of the cannula, cannula was connected to the infusion set. Evaluation was done to assess vein route establishment, canulation attempt number and swelling. Data recorded were analyzed using Statistical Package for the Social Sciences (SPSS) using Chi-square test or Fisher Exact test. Significant value is p\\<0.05."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects aged 0-5 years old\n* Subjects with difficult vein access (e.g. edema, obesity, chemotherapy history),\n* Subjects whose parents had signed the informed consent\n* Subjects with available vein access locations at the back of either hands.\n\nExclusion Criteria:\n\n* Subjects who had infection signs at the designated vein access location\n* Subjects in need of emergency procedures.\n\nDrop out Criteria:\n\n* Subjects resigned from the study\n* Subjects rejected any next attempt of intravenous cannulation\n* Subjects who received anesthetic drugs before intravenous cannulation.'}, 'identificationModule': {'nctId': 'NCT03134560', 'briefTitle': 'Intravenous Cannulation Using Vein Display Instrument and Without Using Vein Display Instrument in Pediatric Patients', 'organization': {'class': 'OTHER', 'fullName': 'Indonesia University'}, 'officialTitle': 'Comparison Between Using Vein Display Instrument and Without Using Vein Display Instrument for Successful Intravenous Cannulation in Pediatric Patients', 'orgStudyIdInfo': {'id': 'IndonesiaUAnes003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'With vein display instrument', 'description': 'Vein cannulation was done after the vein display instrument displays the veins using infrared', 'interventionNames': ['Device: Vein Display Instrument']}, {'type': 'NO_INTERVENTION', 'label': 'Without vein display instrument', 'description': 'vein cannulation was done without any vein display instrument'}], 'interventions': [{'name': 'Vein Display Instrument', 'type': 'DEVICE', 'armGroupLabels': ['With vein display instrument']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10430', 'city': 'Jakarta', 'country': 'Indonesia', 'facility': 'Cipto Mangunkusumo Central National Hospital', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}], 'overallOfficials': [{'name': 'Aries Perdana, Consultant', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indonesia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indonesia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant, Anesthesiologist', 'investigatorFullName': 'Aries Perdana', 'investigatorAffiliation': 'Indonesia University'}}}}