German Point Prevalence Study on CVC

Wolfram Schummer, MD, PhD

Status: Completed

Conditions: Data Collection

Treatments: Other: central venous catheter insertion

Study type: Observational

Funder types: Other

Identifiers

NCT04674371

U1111-1229-1554 (Registry Identifier)

DRKS00016855

Details and patient eligibility

About

It has now been 90 years since Werner Forssmann developed the CVC. Nowadays CVCs play an integral role for critically ill patients.

Despite the high number of central venous access devices inserted annually, there are limited data on the incidence of the associated procedural complications, many of which carry substantial clinical risk. This point was highlighted in recently published Association of Anaesthetists of Great Britain and Ireland "Safe vascular access 2016" guidelines and "Clinical guidelines on central venous catheterisation" in 2014 of the Swedish Society of Anaesthesiology and Intensive Care Medicine.

This German point prevalence study should identify the number of central venous catheter insertions and the incidence of various and especially serious mechanical complications across multiple hospital sites within one day.

Secondary aims are to identify the availability of resources and infrastructure to facilitate safe central venous catheter insertion and management of potential complications.

As much hospital sites as possible should participate and identify all adult central venous catheter insertions, with subsequent review of any complications detected.

Additionally, resources while inserting the CVC should be specified such as ultrasound for assessment of ultrasound anatomy and/or ultrasound-guidance. Furthermore, assessment of the CVC tip should be studied whether done during CVC placement with

• ECG-guidance or by
• transthoracic/transesophageal ultrasound with the Microbubble test or more conventional post hoc with
• bedside chest X-ray Any mechanical complication should be documented untill day three post insertion. The background is to identify possible perforations due to initially unfavorable CVC tip positions (angle > 40 ° to wall of the superior vena cava).

Participation in the study is open to all disciplines (anesthesia, intensive care, internal medicine, surgery, etc.) that regularly perform CVCs.

Full description

Questions

• How experienced are the CVC operators?

• What are the demographics of the patients included?

• How many emergency patients will be included in the study?

• How is the distribution of the punctured vessels and that of the respective sides?

• How many puncture attempts are necessary to achieve a successful CVC placement and how often do problems with the Seldinger-wire occur?

• How often is ultrasound used to place a CVC and if so,

  1. Only for Screening?
  2. Puncture under ultrasound view?

• What is the distribution between short and long axis view?

• What catheter types and which caliber in French are being inserted?

• Catheter position control:

  1. by EKG-lead on Pmax or Pmax - x cm (withdroth)
  2. by means of transthoracic ultrasound and agitated NaCl solution
  3. by means of transesophageal echocardiography and NaCl solution
  4. by means of X-ray image
  5. other or missing position control

• Statement on the position of the CVC tip

• How common are CVC-malpositions and what is their distribution?

• Which complications occur within 72 h? Which measures do you require and how do they affect the respective patient?

Enrollment: 537 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Age

• Inclusion criteria:

  • Adults
  • Young Adults
  • Children
  • Infants
  • Neonates

• Exclusion criteria:

  • None

Procedures

• Inclusion criteria:

  • Elective central venous access procedures
  • Emergency central venous access procedures

• Exclusion criteria:

  • None

Providers

• Inclusion criteria:

  • Anesthesiologists
  • Internist
  • Neurologist
  • Surgeon
  • Etc.

• Exclusion criteria:

  • None

Selection of catheter insertion site

• External jugular
• Internal jugular
• Subclavian
• Femoral

Complications

• Inclusion criteria:

  • Arterial cannulation/injury/cerebral embolization/hemorrhage
  • Catheter or wire shearing or loss
  • Lacerations of great vessels
  • Exsanguination
  • Hemo/pneumothorax; peritoneal hemorrhage
  • Pneumothorax
  • Tamponade
  • Tracheal injury
  • Air embolism
  • Heart puncture (tamponade)
  • Hemothorax
  • Stroke
  • Mortality
  • Number of attempts at central line placement
  • Failed insertion attempts
  • Successful, nontraumatic procedure
  • Wire, needle, catheter issues

• Exclusion criteria:

  • Infections or other complications not associated with central venous catheterization
  • Mechanical injury or trauma not associated with central venous catheterization

Trial design