- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05751395
Siting Central Venous Catheters Precisely While Performing the Access Procedure
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?
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: wolfram Schummer, MD, PhD
- Phone Number: +491726802523
- Email: cwsm.schummer@gmx.de
Study Contact Backup
- Name: Manuel F Struck, MD, PhD
- Phone Number: +49341 - 97 17700
- Email: ManuelFlorian.Struck@medizin.uni-leipzig.de
Study Locations
-
-
Baden Württemberg
-
Überlingen, Baden Württemberg, Germany, 88662
- Helios-Spital
-
Contact:
- wolfram Schummer, MD, PhD
- Phone Number: +491726802523
- Email: cwsm.schummer@gmx.de
-
Contact:
- Ole Bayer, MD
- Phone Number: 5050 +4975519477
- Email: ole.bayer@helios-gesundheit.de
-
-
Saxonia
-
Leipzig, Saxonia, Germany, 04103
- University Clinic Leipzig
-
Contact:
- Manuel F Struck, MD, PhD
- Phone Number: +49341 - 97 17700
- Email: ManuelFlorian.Struck@medizin.uni-leipzig.de
-
Contact:
- Sebastian Stehr, Professor
- Phone Number: +49341 - 97 17700
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Critically ill patients in severe multiple organ dysfunction in need for a second CVC (e.g. for blood purification technique)
Exclusion Criteria:
- Patient selection not fulfilled a/o no need for a second CVC
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
CVCs placed by means of ECG method at P-max
|
Day 1
|
Collaborators and Investigators
Investigators
- Principal Investigator: Wolfram Schummer, MD, PhD, Friedrich Schiller University
Publications and helpful links
General 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.
- Wirsing 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.
- Schummer 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- U1111-1285-5359
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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