Clinical trial NCT04674371: German Point Prevalence Study on CVC
Official title: German Point Prevalence Study on Central Venous Catheter
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Data Collection
Keywords: Central venous catheter
central venous line
Catheterization, Central Venous / access
Catheterization, Central Venous / methods
Catheterization, Central Venous / instrumentation
Catheterization, Central Venous / adverse effects
Placement of larger catheters
Insertion of CVCs
Complication of CVCs
CVC misplacement
Ultrasonography, Interventional / adverse effects
Ultrasonography, Interventional / instrumentation
Ultrasonography, Interventional / methods
Electroctrocardiography, Radiography, Echocardiographie/ TEE
Vascular Access Devices / standards
Vascular Access Devices / trends
Critical Illness / therapy
Humans
Adults, Adolescents
Lead sponsor: Deutsche Interdisziplinäre Vereinigung für Intensiv- und Notfallmedizin
Sponsor class: OTHER
First posted: 2020-12-19
Enrollment: 537
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Over 2000 patients in Germany

Brief summary: 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.

Detailed 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?

Eligibility 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

Primary outcomes:
measure: Patients Demographics
timeFrame: 17.05.2022
measure: Complications and malpositions
timeFrame: 17.05.2022-20.05.2022
Secondary outcomes:
measure: Percentage of the emergency procedure
timeFrame: 17.05.2022
measure: Distribution of the vessel sites und sides
timeFrame: 17.05.2022
measure: Experience of the operator
timeFrame: 17.05.2022
measure: Puncture attempts
timeFrame: 17.05.2022
measure: Type and caliber of catheter
timeFrame: 17.05.2022
measure: Wire problems/issues
timeFrame: 17.05.2022
measure: Ultrasound assistance
timeFrame: 17.05.2022
measure: CVC tip position
timeFrame: 17.05.2022
Other outcomes:
Locations:
city: Berlin-Mitte
country: Germany
facility: Deutsche Interdisziplinäre Vereinigung für Intensiv- und Notfallmedizin e.V.
Study officials:
affiliation: Deutsche Interdisziplinäre Vereinigung für Intensiv- und Notfallmedizin
name: Wolfram Schummer, MD, PhD
role: STUDY_CHAIR
References:
citation: Schmidt GA, Blaivas M, Conrad SA, Corradi F, Koenig S, Lamperti M, Saugel B, Schummer W, Slama M. Ultrasound-guided vascular access in critical illness. Intensive Care Med. 2019 Apr;45(4):434-446. doi: 10.1007/s00134-019-05564-7. Epub 2019 Feb 18.
citation: McGee DC, Gould MK. Preventing complications of central venous catheterization. N Engl J Med. 2003 Mar 20;348(12):1123-33. doi: 10.1056/NEJMra011883. No abstract available.
citation: Schummer W, Sakka SG, Huttemann E, Reinhart K, Schummer C. [Ultrasound guidance for placement control of central venous catheterization. Survey of 802 anesthesia departments for 2007 in Germany]. Anaesthesist. 2009 Jul;58(7):677-85. doi: 10.1007/s00101-009-1569-1. German.
citation: Frykholm P, Pikwer A, Hammarskjold F, Larsson AT, Lindgren S, Lindwall R, Taxbro K, Oberg F, Acosta S, Akeson J. Clinical guidelines on central venous catheterisation. Swedish Society of Anaesthesiology and Intensive Care Medicine. Acta Anaesthesiol Scand. 2014 May;58(5):508-24. doi: 10.1111/aas.12295. Epub 2014 Mar 5.
citation: Coe AJ. AAGBI Safe vascular access guidelines I. Anaesthesia. 2016 Aug;71(8):985. doi: 10.1111/anae.13553. No abstract available.
citation: Bierman S. AAGBI safe vascular access guidelines II. Anaesthesia. 2016 Aug;71(8):985-6. doi: 10.1111/anae.13554. No abstract available.
citation: Lathey RK, Jackson RE, Bodenham A, Harper D, Patle V; Anaesthetic Audit and Research Matrix of Yorkshire (AARMY). A multicentre snapshot study of the incidence of serious procedural complications secondary to central venous catheterisation. Anaesthesia. 2017 Mar;72(3):328-334. doi: 10.1111/anae.13774. Epub 2016 Dec 16.