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Completed

NCT Number: NCT04674371

German Point Prevalence Study on CVC

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.

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Key information

Conditions

Data Collection Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Deutsche Interdisziplinäre Vereinigung für Intensiv- und Notfallmedizin e.V.

Mitte, 10117, Germany

About this study

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,
  • Only for Screening?
  • 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:
  • by EKG-lead on Pmax or Pmax - x cm (withdroth)
  • by means of transthoracic ultrasound and agitated NaCl solution
  • by means of transesophageal echocardiography and NaCl solution
  • by means of X-ray image
  • 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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

central venous catheter insertion

Other

Every operator should perform the CVC Insertion Procedure according to his common clinical practice.

Primary outcomes

  1. Patients Demographics

    Time frame: 17.05.2022

    All patients with a CVC Insertion on May 17th. 2022 in participating Hospitals independent of sex, age or BMI in kg/m^2 are eligible

  2. Complications and malpositions

    Time frame: 17.05.2022-20.05.2022

    Which complications and malpositions occur within 72 h

Secondary outcomes

  1. Percentage of the emergency procedure

    Time frame: 17.05.2022

    How many emergency patients will be included in the study

  2. Distribution of the vessel sites und sides

    Time frame: 17.05.2022

    distribution of the punctured vessels (external jugular, internal jugular, subclavian, femoral

    ) and that of the respective sides

  3. Experience of the operator

    Time frame: 17.05.2022

    Resident physician/ Specialist doctor

  4. Puncture attempts

    Time frame: 17.05.2022

    How many puncture attempts are necessary to achieve a successful CVC

  5. Type and caliber of catheter

    Time frame: 17.05.2022

    What catheter types and which caliber in French are being inserted

  6. Wire problems/issues

    Time frame: 17.05.2022

    witch and how often do problems with the Seldinger-wire occur

  7. Ultrasound assistance

    Time frame: 17.05.2022

    Screening / Online guidance / Short or long axis view

  8. CVC tip position

    Time frame: 17.05.2022

    measures to ensure central venous catheter tip position (i.e. CXR, ECG method and ultrasound)

Sponsors and collaborators

Lead sponsor

Wolfram Schummer, MD, PhD

Other

Registry information

Official study title

German Point Prevalence Study on Central Venous Catheter

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Dec 19, 2020
Registry last updated
Aug 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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