Central Venous CatheterNCT05751395
Siting Central Venous Catheters Precisely While Performing the Access Procedure
An observational study of Central Venous Catheter, run by Deutsche Interdisziplinäre Vereinigung für Intensiv- und Notfallmedizin at 2 sites in Germany.
Trial summary
For central venous catheters (CVC) to function properly, optimal tip location is of utmost importance. One technique to verify CVC position is the ECG method. Nowadays, the ECG method is applied using the maximum P-wave amplitude (P-max). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Venous Catheter
- What is being tested?
- Central Venous Access
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Mar 2023to 31 Dec 2024
- How long will I take part?
- 3 Days
- 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: Only critically ill patients with multiple organ dysfunction treated in an ICU are eligible for the study. Another condition is a prerequisite for reliable illustration of the results, i.e. at least two central venous lines has to be in place. This implies that only patients in need of a second CVC (eg. for blood purification techniques) can be included into the study. All catheters are to be placed using the ECG method with the CVC tip at P-max. In all patients, a chest X-ray has to be performed within 24 hours of line insertion to assess the CVC positions.
Who may be able to join
- Critically ill patients in severe multiple organ dysfunction in need for a second CVC (e.g. for blood purification technique)
Who cannot join
- Patient selection not fulfilled a/o no need for a second CVC
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
University Clinic Leipzig
Leipzig, Saxony, 04103
Manuel F Struck, MD, PhD, +49341 - 97 17700, ManuelFlorian.Struck@medizin.uni-leipzig.de
Sebastian Stehr, Professor, +49341 - 97 17700
Helios-Spital
Überlingen, Baden-Wurttemberg, 88662
wolfram Schummer, MD, PhD, +491726802523, cwsm.schummer@gmx.de
Ole Bayer, MD, +4975519477 ext. 5050, ole.bayer@helios-gesundheit.de
About this study
Official title: Siting Central Venous Catheters Precisely by Means of the ECG Method - A Study to Prove Reliability -
For central venous catheters (CVC) to function properly, optimal tip location is of utmost importance.
One technique to verify CVC position is the ECG method. Nowadays, the ECG method is applied using the maximum P-wave amplitude (P-max).
The hypothesis is that a method believed to be precise in assessing CVC position can provide the same results for CVC tip positions regardless of their respective insertion sites.
Can the ECG method (at P-max) provide the same results for the position of CVC tips regardless of their insertion site?
Read the detailed description
Only critically ill patients with multiple organ dysfunction are eligible for the study. Another condition is a prerequisite for reliable illustration of the results, i.e. at least two central venous lines has to be in place. All catheters are to be placed using the ECG method with the CVC tip at P-max. In all patients, a chest X-ray has to be performed within 24 hours of line insertion to assess the CVC positions.
The University's Institutional Review Board (IRB) registered and approved the study protocol (1518-03/05). The requirement for written informed consent was waived by the IRB.
Central venous catheters (CVC) play an important role in the management of critically ill patients by allowing measurement of haemodynamic variables that cannot be measured accurately by non-invasive means and by allowing delivery of medications and nutritional support that cannot be given safely through peripheral venous catheters. Unfortunately, these catheters are not without potential for harm. The insertion procedure in particular carries the risk of serious mechanical complications, though ultrasound imaging may dramatically reduce this risk.
For the catheter to function properly, tip location is of utmost importance. Inserting the tip too far into the right atrium raises serious risks of arrhythmias or even pericardial tamponade. Inserting it too shallowly - in the innominate vein or the upper third of the superior vena cava - poses the risk of intimal damage and consequently venous thrombosis, fibrin sleeve formation, and persistent withdrawal occlusion. Even with correct initial positioning, these catheters are prone to tip migration. However, the risk of erosion and even perforation of the vein wall also should not, in the light of their intensity, be ignored.
The ECG method of siting CVC tips has undergone marked development over recent decades. At present, the ECG method with its new interpretation - CVC tip at the maximum P-wave amplitude (P-max) - is a stable and reliable bedside method for positioning CVC tips exactly at the transition of the right atrium (RA) and superior vena cava (SVC) in patients in sinus rhythm. This is the only method that directly enables the operator to assess the correct CVC position during insertion. This study investigates the hypothesis that a method believed to be a precise approach to assessing CVC position can provide the same results for the position of two CVC tips regardless of respective insertion sites.
- Conditions
- Central Venous Catheter
- Being tested
- Central Venous Access
- Keywords
- Central venous catheter, Double cannulation, ECG method (intravascular ECG), CVC tips, Verification technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Central Venous AccessDevice
Critically ill patients in severe MODS need a CVC and in some cases also a second line for e-g- blood purification techniques.
All CVCs are positioned via the ECG method with the CVC tip placed at P-max. Within 24 h a chest radiograph is obtained for assessment of the CVCs, especially their tips.
| Study group | Role | What they receive |
|---|---|---|
| Critically ill Patients in severe Multiple Organ Dysfunction | Critically ill Patients in severe Multiple Organ Dysfunction in need of a second Central Venous Catheter (CVC) for e.g. blood purification techniques Receives: Device: Central Venous Access |
What is being measured
The primary outcome is the main question the study is designed to answer.
CVC tips are expected to be at the same level +/- 5 mm
CVCs placed by means of ECG method at P-max
Measured: Day 1
Secondary outcomes (1)
Difference between the level of CVC tips (expected to be at one level +/- 5mm) depending on chosen access site combination (e.g. right internal jugular vein versus left subclavian vein)
CVCs placed by means of ECG method at P-max
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start1 Mar 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Deutsche Interdisziplinäre Vereinigung für Intensiv- und Notfallmedizin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wolfram Schummer, MD, PhD, Deutsche Interdisziplinäre Vereinigung für Intensiv- und Notfallmedizin
- Investigators
- Wolfram Schummer, MD, PhD, Principal investigator, Friedrich Schiller University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05751395
- Sponsor's protocol ID
- U1111-1285-5359
- Status last verified
- Feb 2023
- First submitted
- 6 Dec 2022
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: age gender height weight BMI CVC tip difference Access site and side
Publications
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.
PubMed 21697183Wirsing M, Schummer C, Neumann R, Steenbeck J, Schmidt P, Schummer W. Is traditional reading of the bedside chest radiograph appropriate to detect intraatrial central venous catheter position? Chest. 2008 Sep;134(3):527-533. doi: 10.1378/chest.07-2687. Epub 2008 Jul 18.
PubMed 18641117Schummer W, Schummer C, Schelenz C, Schmidt P, Frober R, Huttemann E. [Modified ECG-guidance for optimal central venous catheter tip positioning. A transesophageal echocardiography controlled study]. Anaesthesist. 2005 Oct;54(10):983-90. doi: 10.1007/s00101-005-0886-2. German.
PubMed 16003543
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Siting Central Venous Catheters Precisely by Means of the ECG Method - A Study to Prove Reliability -
- ClinicalTrials.gov ID
- NCT05751395
- Acronym / sponsor ID
- U1111-1285-5359
- Conditions
- Central Venous Catheter
- Keywords
- Central venous catheter, Double cannulation, ECG method (intravascular ECG), CVC tips, Verification technique
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Deutsche Interdisziplinäre Vereinigung für Intensiv- und NotfallmedizinUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 2 Mar 2023 (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.
For central venous catheters (CVC) to function properly, optimal tip location is of utmost importance.
One technique to verify CVC position is the ECG method. Nowadays, the ECG method is applied using the maximum P-wave amplitude (P-max).
The hypothesis is that a method believed to be precise in assessing CVC position can provide the same results for CVC tip positions regardless of their respective insertion sites.
Can the ECG method (at P-max) provide the same results for the position of CVC tips regardless of their insertion site?
Detailed description
Only critically ill patients with multiple organ dysfunction are eligible for the study. Another condition is a prerequisite for reliable illustration of the results, i.e. at least two central venous lines has to be in place. All catheters are to be placed using the ECG method with the CVC tip at P-max. In all patients, a chest X-ray has to be performed within 24 hours of line insertion to assess the CVC positions.
The University's Institutional Review Board (IRB) registered and approved the study protocol (1518-03/05). The requirement for written informed consent was waived by the IRB.
Central venous catheters (CVC) play an important role in the management of critically ill patients by allowing measurement of haemodynamic variables that cannot be measured accurately by non-invasive means and by allowing delivery of medications and nutritional support that cannot be given safely through peripheral venous catheters. Unfortunately, these catheters are not without potential for harm. The insertion procedure in particular carries the risk of serious mechanical complications, though ultrasound imaging may dramatically reduce this risk.
For the catheter to function properly, tip location is of utmost importance. Inserting the tip too far into the right atrium raises serious risks of arrhythmias or even pericardial tamponade. Inserting it too shallowly - in the innominate vein or the upper third of the superior vena cava - poses the risk of intimal damage and consequently venous thrombosis, fibrin sleeve formation, and persistent withdrawal occlusion. Even with correct initial positioning, these catheters are prone to tip migration. However, the risk of erosion and even perforation of the vein wall also should not, in the light of their intensity, be ignored.
The ECG method of siting CVC tips has undergone marked development over recent decades. At present, the ECG method with its new interpretation - CVC tip at the maximum P-wave amplitude (P-max) - is a stable and reliable bedside method for positioning CVC tips exactly at the transition of the right atrium (RA) and superior vena cava (SVC) in patients in sinus rhythm. This is the only method that directly enables the operator to assess the correct CVC position during insertion. This study investigates the hypothesis that a method believed to be a precise approach to assessing CVC position can provide the same results for the position of two CVC tips regardless of respective insertion sites.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill Patients in severe Multiple Organ Dysfunction | – | Device: Central Venous AccessCritically ill Patients in severe Multiple Organ Dysfunction in need of a second Central Venous Catheter (CVC) for e.g. blood purification techniques |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Only critically ill patients with multiple organ dysfunction treated in an ICU are eligible for the study. Another condition is a prerequisite for reliable illustration of the results, i.e. at least two central venous lines has to be in place. This implies that only patients in need of a second CVC (eg. for blood purification techniques) can be included into the study. All catheters are to be placed using the ECG method with the CVC tip at P-max. In all patients, a chest X-ray has to be performed within 24 hours of line insertion to assess the CVC positions.
Key inclusion criteria (1 listed)
- Critically ill patients in severe multiple organ dysfunction in need for a second CVC (e.g. for blood purification technique)
Key exclusion criteria (1 listed)
- Patient selection not fulfilled a/o no need for a second CVC
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 |
|---|---|---|
| Central Venous AccessCritically ill patients in severe MODS need a CVC and in some cases also a second line for e-g- blood purification techniques. All CVCs are positioned via the ECG method with the CVC tip placed at P-max. Within 24 h a chest radiograph is obtained for assessment of the CVCs, especially their tips. | Device | Critically ill Patients in severe Multiple Organ Dysfunction |
Primary outcome
CVC tips are expected to be at the same level +/- 5 mm
Time frame: Day 1
CVCs placed by means of ECG method at P-max
1 secondary outcome
Difference between the level of CVC tips (expected to be at one level +/- 5mm) depending on chosen access site combination (e.g. right internal jugular vein versus left subclavian vein)
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- 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 18641117Wirsing M, Schummer C, Neumann R, Steenbeck J, Schmidt P, Schummer W. Is traditional reading of the bedside chest radiograph appropriate to detect intraatrial central venous catheter position? Chest. 2008 Sep;134(3):527-533. doi: 10.1378/chest.07-2687. Epub 2008 Jul 18.
- Results publication: PubMed 16003543Schummer W, Schummer C, Schelenz C, Schmidt P, Frober R, Huttemann E. [Modified ECG-guidance for optimal central venous catheter tip positioning. A transesophageal echocardiography controlled study]. Anaesthesist. 2005 Oct;54(10):983-90. doi: 10.1007/s00101-005-0886-2. German.
- Individual participant dataSharing planned: No. age gender height weight BMI CVC tip difference Access site and side
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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.
Wolfram Schummer, MD, PhD principal investigator
Friedrich Schiller University
2 sites 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, run by Deutsche Interdisziplinäre Vereinigung für Intensiv- und Notfallmedizin at 2 sites in Germany.
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 1 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: status not confirmed, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wolfram Schummer, MD, PhD (+491726802523, cwsm.schummer@gmx.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CVC tips are expected to be at the same level +/- 5 mm (time frame: Day 1). 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 NCT05751395, 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 2 Mar 2023.