Siting Central Venous Catheters Precisely While Performing the Access Procedure

NCT05751395 | Unknown

• 1 other identifier: U1111-1285-5359
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 2

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?

Conditions

Central Venous Catheter

Keywords

Central venous catheter; Double cannulation; ECG method (intravascular ECG); CVC tips; Verification technique

Outcome Measures

Primary Outcomes (1)

• CVC tips are expected to be at the same level +/- 5 mm

  CVCs placed by means of ECG method at P-max

  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)

  Day 1

Study Arms (1)

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

Device: Central Venous Access

Interventions

Central Venous Access 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.

Critically ill Patients in severe Multiple Organ Dysfunction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Critically ill patients in severe multiple organ dysfunction in need for a second CVC (e.g. for blood purification technique)

You may not qualify if:

• Patient selection not fulfilled a/o no need for a second CVC

Sponsors & Collaborators

• Deutsche Interdisziplinäre Vereinigung für Intensiv- und Notfallmedizin: lead

Study Sites (2)

Helios-Spital

Überlingen, Baden-Wurttemberg, 88662, Germany

Location

University Clinic Leipzig

Leipzig, Saxony, 04103, Germany

Location

Related Publications (3)

• 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.

  PMID: 21697183 RESULT

• 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.

  PMID: 18641117 RESULT

• 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.

  PMID: 16003543 RESULT

Study Officials

• Wolfram Schummer, MD, PhD

  Friedrich Schiller University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wolfram Schummer, MD, PhD

CONTACT

+491726802523; cwsm.schummer@gmx.de

Manuel F Struck, MD, PhD

CONTACT

+49341 - 97 17700; ManuelFlorian.Struck@medizin.uni-leipzig.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: March 2, 2023
• Study Start: March 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 2, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)