German Point Prevalence Study on CVC
- Conditions
- Data Collection
- Registration Number
- NCT04674371
- Lead Sponsor
- Wolfram Schummer, MD, PhD
- 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?
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 537
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patients Demographics 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
Complications and malpositions 17.05.2022-20.05.2022 Which complications and malpositions occur within 72 h
- Secondary Outcome Measures
Name Time Method Type and caliber of catheter 17.05.2022 What catheter types and which caliber in French are being inserted
Wire problems/issues 17.05.2022 witch and how often do problems with the Seldinger-wire occur
Distribution of the vessel sites und sides 17.05.2022 distribution of the punctured vessels (external jugular, internal jugular, subclavian, femoral
) and that of the respective sidesPercentage of the emergency procedure 17.05.2022 How many emergency patients will be included in the study
Experience of the operator 17.05.2022 Resident physician/ Specialist doctor
Puncture attempts 17.05.2022 How many puncture attempts are necessary to achieve a successful CVC
Ultrasound assistance 17.05.2022 Screening / Online guidance / Short or long axis view
CVC tip position 17.05.2022 measures to ensure central venous catheter tip position (i.e. CXR, ECG method and ultrasound)
Trial Locations
- Locations (1)
Deutsche Interdisziplinäre Vereinigung für Intensiv- und Notfallmedizin e.V.
🇩🇪Berlin-Mitte, Germany