Catheterization, Central VenousNCT04274881
Surface Landmarks and C-length as Predictors of Depth of Right IJV Catheter Insertion: A TEE-Guided Study
An observational study of Catheterization, Central Venous and Echocardiography, Transesophageal, run by Ain Shams University at 1 site in Egypt.
Trial summary
The primary aim of this study is to derive a prediction rule to estimate the required length for placement of the CVC tip at the mid-point of the SVC from simple anatomical landmarks that are consistent with the known surface projections of the great veins. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheterization, Central Venous, Echocardiography, Transesophageal, Anatomic Landmarks
- What is being tested?
- Catheterization of internal jugular vein
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2019to 1 Dec 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult subjects of either sex who are scheduled for elective cardiac surgery in whom echocardiography is indicated or recommended will be eligible.
Who may be able to join
- Adult subjects (age 18 years or older).
- Elective cardiac surgery.
- Echocardiography is indicated or recommended.
Who cannot join
- Previous cardiothoracic or neck surgery.
- Previous radiotherapy on the neck or chest.
- Intra-thoracic or neck mass lesions.
- Deformity of the chest wall.
- Anomalies of the great vessels.
- Congenital heart disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Surface Landmarks and C-length as Predictors of the Depth of Right Internal Jugular Venous Catheter Insertion: A Transesophageal Echocardiography-Guided Study
The primary aim of this study is to derive a prediction rule to estimate the required length for placement of the CVC tip at the mid-point of the SVC from simple anatomical landmarks that are consistent with the known surface projections of the great veins. The accuracy of this rule will be examined using TEE and is intended for adult patients undergoing cannulation of the right IJV utilizing a middle approach. As a secondary aim, we will examine the performance of this suggested rule as contrasted with two other popular methods for estimation of the CVC length, the Peres formula and the C-length method.
Read the detailed description
Before induction of anesthesia
Three sets of measurements will be obtained for each participant before induction of anesthesia:
- Surface measurements: Three points will be placed on the skin using a non-erasable marker. Point A, at the apex of the triangle between the two heads of the sternomastoid. Point B, at the ipsilateral sternoclavicular joint. Point C, at the lower border of the right 2nd rib at its junction with the sternum. The distance between point A and point B and between point B and point C will be measured and added to each other to determine the catheter length expected to place the tip at the mid-SVC.
- Radiological measurements: On the plain posteroanterior (PA) chest X-ray (CXR), the distance from the tip of the transverse process of T1 to the tracheal bifurcation (C-length) will be measured.
- Using Peres' formuls (Height in cm/10), we will record the anti After induction of anesthesia After induction of anaesthesia, the TEE probe will be placed and a bicaval view will be displayed to visualize the right atrium-superior vena cava (RA-SVC) junction and the proximal (lower) part of the SVC at its entry into the right atrium (RA). The TEE probe will be manipulated to display the SVC as far as possible from its junction with the RA.
The right internal jugular vein (IJV) will be cannulated under ultrasound guidance using the Seldinger technique.
After puncture of the IJV a J-wire will be advanced through the trocar until the J-end of the guidewire is visualized at the RA-IJV junction via the TEE.
The CVC catheter will be passed over the guidewire to the RA-SCV junction. The guidewire will be removed and the catheter will then be retracted under TEE guidance until the tip in visualized at 3.0 cm above the RA-SVC junction as measured with the TEE cursor. If the distal (upper) portion of the SVC could not be visualized, the catheter would be retracted for 3 cm as guided by the 1-cm gradations on the CVC.
Post-operative After operation, plain PA CXR will be obtained at the intensive care unit (ICU) to verify the position of the CVC tip in relation to the carina.
Statistical Analysis:
The length of the catheter required to place the tip at the mid SVC will be regressed on the C-length or the surface distance to obtain a predictive equation. The accuracy of either equation will be assessed by estimation of the standard error of the estimate (SEest).
- Conditions
- Catheterization, Central Venous, Echocardiography, Transesophageal, Anatomic Landmarks, Radiography
- Being tested
- Catheterization of internal jugular vein
- Keywords
- Surface landmarks, C-length, Central venous catheterization, Internal jugular vein, Prediction, Accuracy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheterization of internal jugular veinProcedure or surgery
Also called Transesophageal echocardiography (to guide placement of central venous catheter tip at mid-SVC)
The right internal jugular vein will be cannulated under transesophageal echocardiographic (TEE) guidance in order to place the catheter tip in the mid-SVC.
The length of the catheter required to place the tip at the mid-SVC as guided by TEE will be regressed on the C-length or on the distance from the entry point to the surface point corresponding to the mid-SVC on the chest wall in order to obtain a predictive equation.
The accuracy of either equation will be assessed by estimation of the standard error of the estimate (SEest).
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of surface landmarks for prediction of CVC depth required to place the CVC tip at the mid-SVC.
Difference between actual length required to place the CVC tip at the mid-SVC as guided by TEE and the distance from the entry point to the surface point corresponding to the mid-SVC on the chest wall.
Measured: Outcome will be assessed at completion of catheterization procedure
Accuracy of C-length for prediction of CVC depth required to place the CVC tip at the mid-SVC.
Difference between actual length required to place the CVC tip at the mid-SVC as guided by TEE and the C-length.
Measured: Outcome will be assessed at completion of catheterization procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start1 Oct 2019
- Primary completion1 Sep 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheterization, Central VenousStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh M. Hakim, Ain Shams University
- Investigators
- Sameh M Hakim, MD, Study director, Ain Shamd University, Faculty of Medicine, Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04274881
- Sponsor's protocol ID
- FMASU MS 301/2019
- Status last verified
- Apr 2025
- First submitted
- 16 Feb 2020
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Surface Landmarks and C-length as Predictors of the Depth of Right Internal Jugular Venous Catheter Insertion: A Transesophageal Echocardiography-Guided Study
- ClinicalTrials.gov ID
- NCT04274881
- Acronym / sponsor ID
- FMASU MS 301/2019
- Conditions
- Catheterization, Central Venous, Echocardiography, Transesophageal, Anatomic Landmarks, Radiography
- Keywords
- Surface landmarks, C-length, Central venous catheterization, Internal jugular vein, Prediction, Accuracy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 18 Feb 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.
The primary aim of this study is to derive a prediction rule to estimate the required length for placement of the CVC tip at the mid-point of the SVC from simple anatomical landmarks that are consistent with the known surface projections of the great veins. The accuracy of this rule will be examined using TEE and is intended for adult patients undergoing cannulation of the right IJV utilizing a middle approach. As a secondary aim, we will examine the performance of this suggested rule as contrasted with two other popular methods for estimation of the CVC length, the Peres formula and the C-length method.
Detailed description
Before induction of anesthesia
Three sets of measurements will be obtained for each participant before induction of anesthesia:
- Surface measurements: Three points will be placed on the skin using a non-erasable marker. Point A, at the apex of the triangle between the two heads of the sternomastoid. Point B, at the ipsilateral sternoclavicular joint. Point C, at the lower border of the right 2nd rib at its junction with the sternum. The distance between point A and point B and between point B and point C will be measured and added to each other to determine the catheter length expected to place the tip at the mid-SVC.
- Radiological measurements: On the plain posteroanterior (PA) chest X-ray (CXR), the distance from the tip of the transverse process of T1 to the tracheal bifurcation (C-length) will be measured.
- Using Peres' formuls (Height in cm/10), we will record the anti After induction of anesthesia After induction of anaesthesia, the TEE probe will be placed and a bicaval view will be displayed to visualize the right atrium-superior vena cava (RA-SVC) junction and the proximal (lower) part of the SVC at its entry into the right atrium (RA). The TEE probe will be manipulated to display the SVC as far as possible from its junction with the RA.
The right internal jugular vein (IJV) will be cannulated under ultrasound guidance using the Seldinger technique.
After puncture of the IJV a J-wire will be advanced through the trocar until the J-end of the guidewire is visualized at the RA-IJV junction via the TEE.
The CVC catheter will be passed over the guidewire to the RA-SCV junction. The guidewire will be removed and the catheter will then be retracted under TEE guidance until the tip in visualized at 3.0 cm above the RA-SVC junction as measured with the TEE cursor. If the distal (upper) portion of the SVC could not be visualized, the catheter would be retracted for 3 cm as guided by the 1-cm gradations on the CVC.
Post-operative After operation, plain PA CXR will be obtained at the intensive care unit (ICU) to verify the position of the CVC tip in relation to the carina.
Statistical Analysis:
The length of the catheter required to place the tip at the mid SVC will be regressed on the C-length or the surface distance to obtain a predictive equation. The accuracy of either equation will be assessed by estimation of the standard error of the estimate (SEest).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects of either sex who are scheduled for elective cardiac surgery in whom echocardiography is indicated or recommended will be eligible.
Key inclusion criteria (3 listed)
- Adult subjects (age 18 years or older).
- Elective cardiac surgery.
- Echocardiography is indicated or recommended.
Key exclusion criteria (6 listed)
- Previous cardiothoracic or neck surgery.
- Previous radiotherapy on the neck or chest.
- Intra-thoracic or neck mass lesions.
- Deformity of the chest wall.
- Anomalies of the great vessels.
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 |
|---|---|---|
| Catheterization of internal jugular veinAlso: Transesophageal echocardiography (to guide placement of central venous catheter tip at mid-SVC)The right internal jugular vein will be cannulated under transesophageal echocardiographic (TEE) guidance in order to place the catheter tip in the mid-SVC. The length of the catheter required to place the tip at the mid-SVC as guided by TEE will be regressed on the C-length or on the distance from the entry point to the surface point corresponding to the mid-SVC on the chest wall in order to obtain a predictive equation. The accuracy of either equation will be assessed by estimation of the standard error of the estimate (SEest). | Procedure or surgery | – |
Primary outcome
Accuracy of surface landmarks for prediction of CVC depth required to place the CVC tip at the mid-SVC.
Time frame: Outcome will be assessed at completion of catheterization procedure
Difference between actual length required to place the CVC tip at the mid-SVC as guided by TEE and the distance from the entry point to the surface point corresponding to the mid-SVC on the chest wall.
Accuracy of C-length for prediction of CVC depth required to place the CVC tip at the mid-SVC.
Time frame: Outcome will be assessed at completion of catheterization procedure
Difference between actual length required to place the CVC tip at the mid-SVC as guided by TEE and the C-length.
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 1 May 2025.
- 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.
Sameh M Hakim, MD study director
Ain Shamd University, Faculty of Medicine, Department of Anesthesiology
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 Catheterization, Central Venous and Echocardiography, Transesophageal, run by Ain Shams University at 1 site in Egypt.
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 6 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 1 May 2025. 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 Egypt. 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?
Accuracy of surface landmarks for prediction of CVC depth required to place the CVC tip at the mid-SVC. (time frame: Outcome will be assessed at completion of catheterization procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 May 2025.