Siting Central Venous Catheters Precisely While Performing the Access Procedure

NCT ID: NCT05751395

Last Updated: 2023-03-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2024-12-31

Brief 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).

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.

Conditions

Central Venous Catheter

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Central Venous Access

Intervention Type: DEVICE

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.

Interventions

Central Venous Access

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Deutsche Interdisziplinäre Vereinigung für Intensiv- und Notfallmedizin

OTHER

Sponsor Role: lead

Responsible Party

Wolfram Schummer, MD, PhD

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wolfram Schummer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Friedrich Schiller University

Locations

Helios-Spital

Überlingen, Baden-Wurttemberg, Germany

University Clinic Leipzig

Leipzig, Saxony, Germany

Countries

Germany

Central Contacts

Wolfram Schummer, MD, PhD

Role: CONTACT

cwsm.schummer@gmx.de

+491726802523

Manuel F Struck, MD, PhD

Role: CONTACT

ManuelFlorian.Struck@medizin.uni-leipzig.de

+49341 - 97 17700

Facility Contacts

wolfram Schummer, MD, PhD

Role: primary

cwsm.schummer@gmx.de

+491726802523

Ole Bayer, MD

Role: backup

ole.bayer@helios-gesundheit.de

+4975519477 ext. 5050

Manuel F Struck, MD, PhD

Role: primary

ManuelFlorian.Struck@medizin.uni-leipzig.de

+49341 - 97 17700

Sebastian Stehr, Professor

Role: backup

+49341 - 97 17700

References

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.

Reference Type: RESULT

PMID: 21697183 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18641117 (View on PubMed)

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.

Reference Type: RESULT

PMID: 16003543 (View on PubMed)

Other Identifiers

U1111-1285-5359

Identifier Type: -

Identifier Source: org_study_id