Ignite Creation Date:
2025-12-24 @ 5:04 PM
Ignite Modification Date:
2025-12-25 @ 2:43 PM
Study NCT ID:
NCT04215250
Status:
COMPLETED
Last Update Posted:
2020-08-20
First Post:
2019-12-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Accuracy of CVC Depth Prediction in Internal Jugular Veins: The Difference Between The Andropoulos and ECG Methods
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004562', 'term': 'Electrocardiography'}], 'ancestors': [{'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-18', 'studyFirstSubmitDate': '2019-12-30', 'studyFirstSubmitQcDate': '2019-12-30', 'lastUpdatePostDateStruct': {'date': '2020-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CVC prediction depth using andropulous equation', 'timeFrame': '30 minutes', 'description': 'CVC will be inserted in certain depth according to the calculated depth'}], 'secondaryOutcomes': [{'measure': 'ECG change', 'timeFrame': '30 seconds', 'description': 'changes in p wave during CVC insertion'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depth of CVC Insertion']}, 'referencesModule': {'references': [{'pmid': '26830995', 'type': 'RESULT', 'citation': 'Wang L, Liu ZS, Wang CA. Malposition of Central Venous Catheter: Presentation and Management. Chin Med J (Engl). 2016 Jan 20;129(2):227-34. doi: 10.4103/0366-6999.173525. No abstract available.'}, {'pmid': '29744246', 'type': 'RESULT', 'citation': 'Chaskar V, Karnik PP, Dave NM, Garasia M. Comparative Study of Three Methods for Depth of Central Venous Catheter Placement in Children: An Observational Pilot Study. Turk J Anaesthesiol Reanim. 2018 Apr;46(2):116-120. doi: 10.5152/TJAR.2018.32748. Epub 2018 Apr 1.'}, {'pmid': '29480861', 'type': 'RESULT', 'citation': 'Kwon HJ, Jeong YI, Jun IG, Moon YJ, Lee YM. Evaluation of a central venous catheter tip placement for superior vena cava-subclavian central venous catheterization using a premeasured length: A retrospective study. Medicine (Baltimore). 2018 Jan;97(2):e9600. doi: 10.1097/MD.0000000000009600.'}, {'pmid': '25885836', 'type': 'RESULT', 'citation': "Sharma D, Singh VP, Malhotra MK, Gupta K. Optimum depth of central venous catheter - Comparision by pere's, landmark and endocavitory (atrial) ECG technique: A prospective study. Anesth Essays Res. 2013 May-Aug;7(2):216-20. doi: 10.4103/0259-1162.118966."}, {'pmid': '19380312', 'type': 'RESULT', 'citation': 'Na HS, Kim JT, Kim HS, Bahk JH, Kim CS, Kim SD. Practical anatomic landmarks for determining the insertion depth of central venous catheter in paediatric patients. Br J Anaesth. 2009 Jun;102(6):820-3. doi: 10.1093/bja/aep078. Epub 2009 Apr 19.'}, {'pmid': '21697183', 'type': 'RESULT', 'citation': 'Kremser J, Kleemann F, Reinhart K, Schummer W. Optimized method for correct left-sided central venous catheter placement under electrocardiographic guidance. Br J Anaesth. 2011 Oct;107(4):567-72. doi: 10.1093/bja/aer189. Epub 2011 Jun 22.'}, {'pmid': '11574350', 'type': 'RESULT', 'citation': 'Andropoulos DB, Bent ST, Skjonsby B, Stayer SA. The optimal length of insertion of central venous catheters for pediatric patients. Anesth Analg. 2001 Oct;93(4):883-6. doi: 10.1097/00000539-200110000-00016.'}, {'pmid': '26660038', 'type': 'RESULT', 'citation': 'Struck MF, Schmidt T, Winkler BE, Reinhart K, Schummer W. Formulas for prediction of insertion depths of internal jugular vein catheters adjusted to body height categories. J Vasc Access. 2016 Mar-Apr;17(2):191-4. doi: 10.5301/jva.5000488. Epub 2015 Dec 7.'}]}, 'descriptionModule': {'briefSummary': 'compare the accuracy of CVC depth prediction in internal jugular veins: the difference between the andropoulos and ECG methods', 'detailedDescription': 'seventy two subjects were given informed consent before the study started. compare the accuracy of CVC depth prediction in internal jugular veins with two difference methods, the andropoulos method and ECG method.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* signing informed consent form\n* indicated for CVC insertion\n* has no contraindication for right internal jugular vein CVC insertion\n\nExclusion Criteria:\n\n* has history of arrhythmia\n* has cardiac malformation history'}, 'identificationModule': {'nctId': 'NCT04215250', 'briefTitle': 'Accuracy of CVC Depth Prediction in Internal Jugular Veins: The Difference Between The Andropoulos and ECG Methods', 'organization': {'class': 'OTHER', 'fullName': 'Indonesia University'}, 'officialTitle': 'Accuracy of CVC Depth Prediction in Internal Jugular Veins: The Difference Between The Andropoulos and ECG Methods', 'orgStudyIdInfo': {'id': 'IndonesiaUAnes 042'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Andropulous method', 'description': 'Andropulous method uses equations to determine the depth of CVC insertion.\n\nFor subject with \\<100 cm in height:\n\nDepth of CVC insertion (cm) = (height (cm)/ 10)-1\n\nFor subject with \\>100 cm in height:\n\nDepth of CVC insertion (cm) = (height (cm)/ 10)-2', 'interventionNames': ['Other: andropulous method']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ECG method', 'description': 'change in p wave from ECG', 'interventionNames': ['Device: ECG']}], 'interventions': [{'name': 'andropulous method', 'type': 'OTHER', 'description': 'Counts the CVC depth using specific equation', 'armGroupLabels': ['Andropulous method']}, {'name': 'ECG', 'type': 'DEVICE', 'description': 'Using ECG to monitor the insertion of the CVC', 'armGroupLabels': ['ECG method']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10430', 'city': 'Jakarta', 'state': 'DKI Jakarta', 'country': 'Indonesia', 'facility': 'Cipto Mangunkusumo Cental National Hospital', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}], 'overallOfficials': [{'name': 'Aida R Tantri', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indonesia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indonesia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthesiologist Consultant', 'investigatorFullName': 'Aida Rosita Tantri', 'investigatorAffiliation': 'Indonesia University'}}}}