NCT04215250

Brief Summary

compare the accuracy of CVC depth prediction in internal jugular veins: the difference between the andropoulos and ECG methods

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 12, 2019

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

December 30, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 2, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2020

Completed
Last Updated

August 20, 2020

Status Verified

August 1, 2020

Enrollment Period

6 months

First QC Date

December 30, 2019

Last Update Submit

August 18, 2020

Conditions

Depth of CVC Insertion

Outcome Measures

Primary Outcomes (1)

  • CVC prediction depth using andropulous equation

    CVC will be inserted in certain depth according to the calculated depth

    30 minutes

Secondary Outcomes (1)

  • ECG change

    30 seconds

Study Arms (2)

Andropulous method

ACTIVE COMPARATOR

Andropulous method uses equations to determine the depth of CVC insertion. For subject with \<100 cm in height: Depth of CVC insertion (cm) = (height (cm)/ 10)-1 For subject with \>100 cm in height: Depth of CVC insertion (cm) = (height (cm)/ 10)-2

Other: andropulous method

ECG method

ACTIVE COMPARATOR

change in p wave from ECG

Device: ECG

Interventions

andropulous methodOTHER

Counts the CVC depth using specific equation

Andropulous method
ECGDEVICE

Using ECG to monitor the insertion of the CVC

ECG method

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • signing informed consent form
  • indicated for CVC insertion
  • has no contraindication for right internal jugular vein CVC insertion

You may not qualify if:

  • has history of arrhythmia
  • has cardiac malformation history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cipto Mangunkusumo Cental National Hospital

Jakarta, DKI Jakarta, 10430, Indonesia

Location

Related Publications (8)

  • 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: 26830995RESULT

  • 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: 29744246RESULT

  • 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: 29480861RESULT

  • 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: 25885836RESULT

  • 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: 19380312RESULT

  • 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: 21697183RESULT

  • 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: 11574350RESULT

  • 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.

    PMID: 26660038RESULT

MeSH Terms

Interventions

Electrocardiography

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosis

Study Officials

  • Aida R Tantri

    Indonesia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist Consultant

Study Record Dates

First Submitted

December 30, 2019

First Posted

January 2, 2020

Study Start

December 12, 2019

Primary Completion

June 12, 2020

Study Completion

June 12, 2020

Last Updated

August 20, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)