German Point Prevalence Study on CVC

NCT04674371 | Completed

• 2 other identifiers: DRKS00016855U1111-1229-1554
• Study Type: observational
• Target: 537
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

• Complications and malpositions

  Which complications and malpositions occur within 72 h

  17.05.2022-20.05.2022

Secondary Outcomes (8)

• Percentage of the emergency procedure

  17.05.2022

• Distribution of the vessel sites und sides

  17.05.2022

• Experience of the operator

  17.05.2022

• Puncture attempts

  17.05.2022

• Type and caliber of catheter

  17.05.2022

Interventions

central venous catheter insertion OTHER

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Over 2000 patients in Germany

You may qualify if:

• Adults
• Young Adults
• Children
• Infants
• Neonates

You may not qualify if:

• None
• Procedures
• Elective central venous access procedures
• Emergency central venous access procedures
• None
• Providers
• Anesthesiologists
• Internist
• Neurologist
• Surgeon
• Etc.
• None
• Selection of catheter insertion site
• External jugular
• Internal jugular

Sponsors & Collaborators

• Wolfram Schummer, MD, PhD: lead

Study Sites (1)

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

Mitte, 10117, Germany

Location

Related Publications (7)

• 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.

  PMID: 30778648 BACKGROUND

• 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.

  PMID: 12646670 BACKGROUND

• 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.

  PMID: 19547936 BACKGROUND

• 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.

  PMID: 24593804 BACKGROUND

• Coe AJ. AAGBI Safe vascular access guidelines I. Anaesthesia. 2016 Aug;71(8):985. doi: 10.1111/anae.13553. No abstract available.

  PMID: 27396261 BACKGROUND

• Bierman S. AAGBI safe vascular access guidelines II. Anaesthesia. 2016 Aug;71(8):985-6. doi: 10.1111/anae.13554. No abstract available.

  PMID: 27396262 BACKGROUND

• 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.

  PMID: 27981565 BACKGROUND

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wolfram Schummer, MD, PhD

  Deutsche Interdisziplinäre Vereinigung für Intensiv- und Notfallmedizin

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PD Dr. med. Dr. med. habil.

Study Record Dates

• First Submitted: December 13, 2020
• First Posted: December 19, 2020
• Study Start: May 17, 2022
• Primary Completion: May 20, 2022
• Study Completion: May 20, 2022
• Last Updated: August 10, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)