Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-25 @ 2:27 PM
Study NCT ID:
NCT04378166
Status:
UNKNOWN
Last Update Posted:
2022-05-05
First Post:
2020-05-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
AR for Pediatric Central Venous Catheterization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Compares central venous catheterization using smart-glasses and conventional method'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2023-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-04', 'studyFirstSubmitDate': '2020-05-04', 'studyFirstSubmitQcDate': '2020-05-04', 'lastUpdatePostDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1st success rate', 'timeFrame': 'From start of central venous catheterization to successful placement of the guidewire at superior vena cava. Not to exceed 20 minutes.', 'description': 'Success rate of central venous catheterization in first trial'}], 'secondaryOutcomes': [{'measure': 'Overall success rate', 'timeFrame': 'From start of central venous catheterization to successful placement of the guidewire at superior vena cava. Not to exceed 3 attempts and 20 minutes.', 'description': 'Overall success rate of central venous catheterization'}, {'measure': 'Elapsed time for catheterization', 'timeFrame': 'From start of central venous catheterization to finish of catheterization. Not to exceed 3 attempts and 20 minutes.', 'description': 'Overall elapsed time of central venous catheterization'}, {'measure': 'Complication', 'timeFrame': 'From end of catheterization to 24 hours after catheterization', 'description': 'Incidence and characteristics of complication related to central venous catheterization'}, {'measure': 'Satisfaction score', 'timeFrame': 'From start of catheterization to end of catheterization. Not to exceed 20 minutes.', 'description': '5-points satisfaction score of practitioner (5 - Best / 4 - Good / 3 - Acceptable / 2 - Poor / 1 - Worst)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesia']}, 'referencesModule': {'references': [{'pmid': '8435256', 'type': 'BACKGROUND', 'citation': 'Alderson PJ, Burrows FA, Stemp LI, Holtby HM. Use of ultrasound to evaluate internal jugular vein anatomy and to facilitate central venous cannulation in paediatric patients. Br J Anaesth. 1993 Feb;70(2):145-8. doi: 10.1093/bja/70.2.145.'}, {'pmid': '27057741', 'type': 'BACKGROUND', 'citation': 'Lau CS, Chamberlain RS. Ultrasound-guided central venous catheter placement increases success rates in pediatric patients: a meta-analysis. Pediatr Res. 2016 Aug;80(2):178-84. doi: 10.1038/pr.2016.74. Epub 2016 Apr 8.'}, {'pmid': '11012954', 'type': 'BACKGROUND', 'citation': 'Verghese ST, McGill WA, Patel RI, Sell JE, Midgley FM, Ruttimann UE. Comparison of three techniques for internal jugular vein cannulation in infants. Paediatr Anaesth. 2000;10(5):505-11. doi: 10.1046/j.1460-9592.2000.00554.x.'}, {'pmid': '30361397', 'type': 'BACKGROUND', 'citation': 'de Souza TH, Brandao MB, Nadal JAH, Nogueira RJN. Ultrasound Guidance for Pediatric Central Venous Catheterization: A Meta-analysis. Pediatrics. 2018 Nov;142(5):e20181719. doi: 10.1542/peds.2018-1719.'}, {'pmid': '28068887', 'type': 'BACKGROUND', 'citation': 'Hiranaka T, Nakanishi Y, Fujishiro T, Hida Y, Tsubosaka M, Shibata Y, Okimura K, Uemoto H. The Use of Smart Glasses for Surgical Video Streaming. Surg Innov. 2017 Apr;24(2):151-154. doi: 10.1177/1553350616685431. Epub 2017 Jan 9.'}, {'pmid': '29785148', 'type': 'BACKGROUND', 'citation': 'Huang CY, Thomas JB, Alismail A, Cohen A, Almutairi W, Daher NS, Terry MH, Tan LD. The use of augmented reality glasses in central line simulation: "see one, simulate many, do one competently, and teach everyone". Adv Med Educ Pract. 2018 May 10;9:357-363. doi: 10.2147/AMEP.S160704. eCollection 2018.'}, {'pmid': '27930431', 'type': 'BACKGROUND', 'citation': 'Rochlen LR, Levine R, Tait AR. First-Person Point-of-View-Augmented Reality for Central Line Insertion Training: A Usability and Feasibility Study. Simul Healthc. 2017 Feb;12(1):57-62. doi: 10.1097/SIH.0000000000000185.'}, {'pmid': '30442261', 'type': 'BACKGROUND', 'citation': 'Song IK, Kim EH, Lee JH, Jang YE, Kim HS, Kim JT. Seldinger vs modified Seldinger techniques for ultrasound-guided central venous catheterisation in neonates: a randomised controlled trial. Br J Anaesth. 2018 Dec;121(6):1332-1337. doi: 10.1016/j.bja.2018.08.008. Epub 2018 Sep 7.'}, {'pmid': '23478546', 'type': 'BACKGROUND', 'citation': 'Bruzoni M, Slater BJ, Wall J, St Peter SD, Dutta S. A prospective randomized trial of ultrasound- vs landmark-guided central venous access in the pediatric population. J Am Coll Surg. 2013 May;216(5):939-43. doi: 10.1016/j.jamcollsurg.2013.01.054. Epub 2013 Mar 7.'}, {'pmid': '26248059', 'type': 'BACKGROUND', 'citation': 'Song IK, Lee JH, Kang JE, Oh HW, Kim HS, Park HP, Kim JT. Comparison of central venous catheterization techniques in pediatric patients: needle vs angiocath. Paediatr Anaesth. 2015 Nov;25(11):1120-6. doi: 10.1111/pan.12726. Epub 2015 Aug 6.'}]}, 'descriptionModule': {'briefSummary': 'This study is intended to investigate usefulness of smart-glasses for ultrasound-guided central venous catheterization in pediatric patients, by comparing success rate and elapsed time. The hypothesis is that smart-glasses would increase success rate in first trial.', 'detailedDescription': "After obtaining informed consent from patients' legal guardian, children aged 6 or less undergoing surgery with need for central venous catheterization will be enrolled to the study.\n\nPatients will be divided into either study group or control group. After anesthetic induction, central venous catheterization will be performed under ultrasound guidance. For patients in study group, the practitioner will be equipped with smart-glasses, while conventional ultrasound-guided catheterization will be performed for patients in control group.\n\nSuccess rate of first trial, overall success rate, elapsed time during catheterization, complication regarding catheterization will be recorded and compared."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are planned to undergo surgery under general anesthesia\n* Patients in need for central venous catheterization during anesthesia\n\nExclusion Criteria:\n\n* Patients who have any of infection, hematoma, skin lesion, recent attempt of puncture at right internal jugular vein\n* Patients with unstable vital sign prior to anesthetic induction\n* Patients who are not eligible for catheterization at right internal jugular vein\n* Refusal of legal guardian of patient'}, 'identificationModule': {'nctId': 'NCT04378166', 'briefTitle': 'AR for Pediatric Central Venous Catheterization', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'The Usefulness of Smart-glasses During Ultrasound-guided Central Venous Catheterization in Pediatric Patients: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2003-018-1106'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Smart glasses', 'description': 'Application of smart glasses for ultrasound-guided central venous catheterization', 'interventionNames': ['Device: Smart glass']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Conventional ultrasound-guided central venous catheterization'}], 'interventions': [{'name': 'Smart glass', 'type': 'DEVICE', 'description': 'Practitioner wears smart glasses connected to ultrasound machine during central venous catheterization', 'armGroupLabels': ['Smart glasses']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jin-Tae Kim, Pf.', 'role': 'CONTACT', 'email': 'jintae73@gmail.com', 'phone': '+82-2-2072-3295'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Sang-Hwan Ji, M.D., M.S.', 'role': 'CONTACT', 'email': 'taepoongshin@gmail.com', 'phone': '82-2-2072-3661'}], 'overallOfficials': [{'name': 'Jin-Tae Kim, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, Professor', 'investigatorFullName': 'Jin-Tae Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}