German Point Prevalence Study on CVC

Data Collection Clinical Trial

Official title:

German Point Prevalence Study on Central Venous Catheter

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04674371
• Other study ID #: DRKS00016855
• Secondary ID: U1111-1229-1554
• Status: Completed
• Start date: May 17, 2022
• Est. completion date: May 20, 2022

Study information

• Verified date: May 2022
• Source: Deutsche Interdisziplinäre Vereinigung für Intensiv- und Notfallmedizin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 537
• Est. completion date: May 20, 2022
• Est. primary completion date: May 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Data Collection

Intervention

Other:
• central venous catheter insertion
Every operator should perform the CVC Insertion Procedure according to his common clinical practice.

Locations

Country	Name	City	State
Germany	Deutsche Interdisziplinäre Vereinigung für Intensiv- und Notfallmedizin e.V.	Berlin-Mitte

Sponsors (1)

Lead Sponsor	Collaborator
Wolfram Schummer, MD, PhD

Country where clinical trial is conducted

Germany, 

References & Publications (7)

Bierman S. AAGBI safe vascular access guidelines II. Anaesthesia. 2016 Aug;71(8):985-6. doi: 10.1111/anae.13554. — View Citation

Coe AJ. AAGBI Safe vascular access guidelines I. Anaesthesia. 2016 Aug;71(8):985. doi: 10.1111/anae.13553. — View Citation

Frykholm P, Pikwer A, Hammarskjöld 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. — View 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. — View Citation

McGee DC, Gould MK. Preventing complications of central venous catheterization. N Engl J Med. 2003 Mar 20;348(12):1123-33. Review. — View 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. Review. — View Citation

Schummer W, Sakka SG, Hüttemann 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients Demographics	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	17.05.2022
Primary	Complications and malpositions	Which complications and malpositions occur within 72 h	17.05.2022-20.05.2022
Secondary	Percentage of the emergency procedure	How many emergency patients will be included in the study	17.05.2022
Secondary	Distribution of the vessel sites und sides	distribution of the punctured vessels (external jugular, internal jugular, subclavian, femoral; ) and that of the respective sides	17.05.2022
Secondary	Experience of the operator	Resident physician/ Specialist doctor	17.05.2022
Secondary	Puncture attempts	How many puncture attempts are necessary to achieve a successful CVC	17.05.2022
Secondary	Type and caliber of catheter	What catheter types and which caliber in French are being inserted	17.05.2022
Secondary	Wire problems/issues	witch and how often do problems with the Seldinger-wire occur	17.05.2022
Secondary	Ultrasound assistance	Screening / Online guidance / Short or long axis view	17.05.2022
Secondary	CVC tip position	measures to ensure central venous catheter tip position (i.e. CXR, ECG method and ultrasound)	17.05.2022