Central Venous CatheterNCT05176886
Correct Tip Position of Central Venous Catheters
An observational study of Central Venous Catheter and Internal Jugular Vein, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Patients, ages between 18-70 years, who require central venous catheter will be enrolled for the study. Central venous catheter will be inserted using patient's height formula by Seldinger technique. Anterioposterior chest radiography will be used to assess the correct tip position. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Central Venous Catheter, Internal Jugular Vein, Radiography
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Jul 2018to 31 Mar 2022
- Phase
- Observational
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in intensive care unit and operating room who require a central venous catheter (right or left-sided) will be enrolled for the study.
Who may be able to join
- Central venous catheterization of patients, ages between 18 and 70
Who cannot join
- Patient's refusal
- Pathology of carotid artery
- Anatomical deformity of the neck (scar, mass effect, multiple central venous catheterization)
- Chest deformities (pectus excavatum, pectus carinatum)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Bozyaka Training and Research Hospital
Izmir
About this study
Official title: Assessment of the Correct Tip Position of Central Venous Catheters, Inserted Using Patient's Height Formula
Patients, ages between 18-70 years, who require central venous catheter will be enrolled for the study. Central venous catheter will be inserted using patient's height formula by Seldinger technique. Anterioposterior chest radiography will be used to assess the correct tip position. Catheters that are below the carina more than 1 cm, will be pulled back for repositioning. Catheters that are above the carina more than 1 cm, will be changed by another catheter. The investigators aim to evaluate the formula for correct tip positioning for central venous catheters
Read the detailed description
Central venous catheters are used for fluid infusion, nutrition, blood transfusion, hemodynamic monitorization in both intensive care unit and operating room. The superior vena cava and right atrium (SVC-RA) junction is considered the optimal position for central venous catheter tip. Carina corresponds to the SVC-RA junction on chest radiograph. Catheter tips, 1 cm above and 1 cm below the carina are considered as the correct position. 18-70 years old patients will be enrolled for the study. Central venous catheters will be inserted via internal jugular vein or subclavian vein using patient's height formula by Seldinger technique. Postprocedural (within 6 hours) chest radiograph will be used to evaluate the correct tip position from the Picture Archiving and Communication System. This formula was described by Peres. If the tip of the catheter is below the carina more than 1 cm, it will be pulled back for repositioning. If the tip of the catheter is above the carina more than 1 cm, another catheter will be inserted. The formula is height (cm)/10 for right internal jugular vein, height(cm)/10-2 for right subclavian vein, height(cm)/10+4 for left internal jugular vein and height(cm)/10+2 for left subclavian vein. Number of the correct and incorrect position of central venous catheter tips will be noted.
The investigators aim to evaluate the reliability and efficiency of Peres' formula for the correct tip position.
- Keywords
- central venous catheter insertion, Peres' formula, correct tip position, carina
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of correct position of central venous catheter tip
Central venous catheter tip should be placed at the superior vena cava and right atrium junction. This junction is defined as carina in anteroposterior chest x-ray imagining. Correct tip position is defined as 1 cm above and 1 cm below the carina.Postprocedural chest radiography will be used.
Measured: Within 6 hours after placement of central venous catheter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start8 Jul 2018
- Primary completion1 Jan 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Central Venous CatheterStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bozyaka Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halide Hande Şahinkaya, Bozyaka Training and Research Hospital
- Investigators
- Halide H Şahinkaya, MD, Study chair, Izmir Bozyaka Training and Research HospitalMine Parlak, MD, Study chair, Izmir Bozyaka Training and Research HospitalZeki T Tekgül, MD, Study chair, Izmir Bozyaka Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05176886
- Sponsor's protocol ID
- Catheter
- Status last verified
- May 2023
- First submitted
- 27 Nov 2021
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Joshi AM, Bhosale GP, Parikh GP, Shah VR. Optimal positioning of right-sided internal jugular venous catheters: comparison of intra-atrial electrocardiography versus Peres' formula. Indian J Crit Care Med. 2008 Jan;12(1):10-4. doi: 10.4103/0972-5229.40943.
PubMed 19826584Kujur R, Rao MS, Mrinal M. How correct is the correct length for central venous catheter insertion. Indian J Crit Care Med. 2009 Jul-Sep;13(3):159-62. doi: 10.4103/0972-5229.58543.
PubMed 20040815Salimi F, Imani MR, Ghasemi N, Keshavarzian A, Jazi AH. The mid-sternal length, a practical anatomical landmark for optimal positioning of long-term central venous catheters. J Res Med Sci. 2013 May;18(5):383-6.
PubMed 24174941
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Correct Tip Position of Central Venous Catheters, Inserted Using Patient's Height Formula
- ClinicalTrials.gov ID
- NCT05176886
- Acronym / sponsor ID
- Catheter
- Keywords
- central venous catheter insertion, Peres' formula, correct tip position, carina
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Bozyaka Training and Research HospitalUniversity, hospital or other
- Study start
- 8 Jul 2018 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 4 Jan 2022 (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.
Patients, ages between 18-70 years, who require central venous catheter will be enrolled for the study. Central venous catheter will be inserted using patient's height formula by Seldinger technique. Anterioposterior chest radiography will be used to assess the correct tip position. Catheters that are below the carina more than 1 cm, will be pulled back for repositioning. Catheters that are above the carina more than 1 cm, will be changed by another catheter. The investigators aim to evaluate the formula for correct tip positioning for central venous catheters
Detailed description
Central venous catheters are used for fluid infusion, nutrition, blood transfusion, hemodynamic monitorization in both intensive care unit and operating room. The superior vena cava and right atrium (SVC-RA) junction is considered the optimal position for central venous catheter tip. Carina corresponds to the SVC-RA junction on chest radiograph. Catheter tips, 1 cm above and 1 cm below the carina are considered as the correct position. 18-70 years old patients will be enrolled for the study. Central venous catheters will be inserted via internal jugular vein or subclavian vein using patient's height formula by Seldinger technique. Postprocedural (within 6 hours) chest radiograph will be used to evaluate the correct tip position from the Picture Archiving and Communication System. This formula was described by Peres. If the tip of the catheter is below the carina more than 1 cm, it will be pulled back for repositioning. If the tip of the catheter is above the carina more than 1 cm, another catheter will be inserted. The formula is height (cm)/10 for right internal jugular vein, height(cm)/10-2 for right subclavian vein, height(cm)/10+4 for left internal jugular vein and height(cm)/10+2 for left subclavian vein. Number of the correct and incorrect position of central venous catheter tips will be noted.
The investigators aim to evaluate the reliability and efficiency of Peres' formula for the correct tip position.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in intensive care unit and operating room who require a central venous catheter (right or left-sided) will be enrolled for the study.
Key inclusion criteria (1 listed)
- Central venous catheterization of patients, ages between 18 and 70
Key exclusion criteria (4 listed)
- Patient's refusal
- Pathology of carotid artery
- Anatomical deformity of the neck (scar, mass effect, multiple central venous catheterization)
- Chest deformities (pectus excavatum, pectus carinatum)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of correct position of central venous catheter tip
Time frame: Within 6 hours after placement of central venous catheter
Central venous catheter tip should be placed at the superior vena cava and right atrium junction. This junction is defined as carina in anteroposterior chest x-ray imagining. Correct tip position is defined as 1 cm above and 1 cm below the carina.Postprocedural chest radiography will be used.
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 12 May 2023.
- Background: PubMed 19826584Joshi AM, Bhosale GP, Parikh GP, Shah VR. Optimal positioning of right-sided internal jugular venous catheters: comparison of intra-atrial electrocardiography versus Peres' formula. Indian J Crit Care Med. 2008 Jan;12(1):10-4. doi: 10.4103/0972-5229.40943.
- Background: PubMed 20040815Kujur R, Rao MS, Mrinal M. How correct is the correct length for central venous catheter insertion. Indian J Crit Care Med. 2009 Jul-Sep;13(3):159-62. doi: 10.4103/0972-5229.58543.
- Background: PubMed 24174941Salimi F, Imani MR, Ghasemi N, Keshavarzian A, Jazi AH. The mid-sternal length, a practical anatomical landmark for optimal positioning of long-term central venous catheters. J Res Med Sci. 2013 May;18(5):383-6.
- Individual participant dataSharing planned: No
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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.
Halide H Şahinkaya, MD study chair
Izmir Bozyaka Training and Research Hospital
Mine Parlak, MD study chair
Izmir Bozyaka Training and Research Hospital
Zeki T Tekgül, MD study chair
Izmir Bozyaka Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Venous Catheter and Internal Jugular Vein, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 4 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 12 May 2023. 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 Turkey (Türkiye). 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?
Number of correct position of central venous catheter tip (time frame: Within 6 hours after placement of central venous catheter). 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 NCT05176886, which also lists 3 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 12 May 2023.