Depth of CVC InsertionNCT04215250
Accuracy of CVC Depth Prediction in Internal Jugular Veins: The Difference Between The Andropoulos and ECG Methods
A study testing andropulous method and ECG in people with Depth of CVC Insertion, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
compare the accuracy of CVC depth prediction in internal jugular veins: the difference between the andropoulos and ECG methods Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Depth of CVC Insertion
- What is being tested?
- andropulous method and ECG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteIndonesia
- Study dates
- 12 Dec 2019to 12 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- signing informed consent form
- indicated for CVC insertion
- has no contraindication for right internal jugular vein CVC insertion
Who cannot join
- has history of arrhythmia
- has cardiac malformation history
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo Cental National Hospital
Jakarta, DKI Jakarta, 10430
About this study
compare the accuracy of CVC depth prediction in internal jugular veins: the difference between the andropoulos and ECG methods
Read the detailed description
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.
- Conditions
- Depth of CVC Insertion
- Being tested
- andropulous method, ECG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
andropulous methodOther
Counts the CVC depth using specific equation
ECGDevice
Using ECG to monitor the insertion of the CVC
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: andropulous method |
| ECG method | Active comparator | change in p wave from ECG Receives: Device: ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
CVC prediction depth using andropulous equation
CVC will be inserted in certain depth according to the calculated depth
Measured: 30 minutes
Secondary outcomes (1)
ECG change
changes in p wave during CVC insertion
Measured: 30 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start12 Dec 2019
- Primary completion12 Jun 2020
- Study completion12 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Depth of CVC InsertionStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aida Rosita Tantri, Universitas Indonesia
- Investigators
- Aida R Tantri, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04215250
- Sponsor's protocol ID
- IndonesiaUAnes 042
- Status last verified
- Aug 2020
- First submitted
- 30 Dec 2019
- Last updated
- 20 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26830995Chaskar 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.
PubMed 29744246Kwon 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.
PubMed 29480861Sharma 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.
PubMed 25885836Na 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.
PubMed 19380312Kremser 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.
PubMed 21697183Andropoulos 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.
PubMed 11574350Struck 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.
PubMed 26660038
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of CVC Depth Prediction in Internal Jugular Veins: The Difference Between The Andropoulos and ECG Methods
- ClinicalTrials.gov ID
- NCT04215250
- Acronym / sponsor ID
- IndonesiaUAnes 042
- Conditions
- Depth of CVC Insertion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 12 Dec 2019 (actual)
- Primary completion
- 12 Jun 2020 (actual)
- Study completion
- 12 Jun 2020 (actual)
- First posted
- 2 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
compare the accuracy of CVC depth prediction in internal jugular veins: the difference between the andropoulos and ECG methods
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Andropulous method | Active comparator | Other: andropulous methodAndropulous 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 |
| ECG method | Active comparator | Device: ECGchange in p wave from ECG |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- signing informed consent form
- indicated for CVC insertion
- has no contraindication for right internal jugular vein CVC insertion
Key exclusion criteria (2 listed)
- has history of arrhythmia
- has cardiac malformation history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| andropulous methodCounts the CVC depth using specific equation | Other | Andropulous method |
| ECGUsing ECG to monitor the insertion of the CVC | Device | ECG method |
Primary outcome
CVC prediction depth using andropulous equation
Time frame: 30 minutes
CVC will be inserted in certain depth according to the calculated depth
1 secondary outcome
ECG change
Time frame: 30 seconds
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2020.
- Results publication: PubMed 26830995Wang 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.
- Results publication: PubMed 29744246Chaskar 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.
- Results publication: PubMed 29480861Kwon 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.
- Results publication: PubMed 25885836Sharma 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.
- Results publication: PubMed 19380312Na 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.
- Results publication: PubMed 21697183Kremser 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.
- Results publication: PubMed 11574350Andropoulos 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.
- Results publication: PubMed 26660038Struck 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aida R Tantri principal investigator
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing andropulous method and ECG in people with Depth of CVC Insertion, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CVC prediction depth using andropulous equation (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04215250, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2020.