Siting Central Venous Catheters Precisely While Performing the Access Procedure

Not yet recruiting

• Conditions: Central Venous Catheter
• Interventions: Device: Central Venous Access

• Registration Number: NCT05751395
• Lead Sponsor: Deutsche Interdisziplinäre Vereinigung für Intensiv- und Notfallmedizin

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.

Study Timeline

• Study First Submitted: 2022-12-06
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-20
• Last Update Submitted: 2023-02-20
• Study Start: 2023-03-01
• Study First Posted: 2023-03-02
• Last Update Posted: 2023-03-02
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Critically ill Patients in severe Multiple Organ Dysfunction	Central Venous Access	Critically ill Patients in severe Multiple Organ Dysfunction in need of a second Central Venous Catheter (CVC) for e.g. blood purification techniques

Primary Outcome Measures

Name	Time	Method
CVC tips are expected to be at the same level +/- 5 mm	Day 1	CVCs placed by means of ECG method at P-max

Secondary Outcome Measures

Name	Time	Method
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)	Day 1	CVCs placed by means of ECG method at P-max

Trial Locations

Locations (2)

University Clinic Leipzig; 🇩🇪 Leipzig, Saxonia, Germany

Helios-Spital; 🇩🇪 Überlingen, Baden Württemberg, Germany