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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1229-1554 | Registry Identifier | World Health Organization [WHO] Registry Network |
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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
Participation in the study is open to all disciplines (anesthesia, intensive care, internal medicine, surgery, etc.) that regularly perform CVCs.
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,
What is the distribution between short and long axis view?
What catheter types and which caliber in French are being inserted?
Catheter 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?
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| central venous catheter insertion | Other | Every operator should perform the CVC Insertion Procedure according to his common clinical practice. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of the emergency procedure | How many emergency patients will be included in the study | 17.05.2022 |
| Distribution of the vessel sites und sides | distribution of the punctured vessels (external jugular, internal jugular, subclavian, femoral ) and that of the respective sides |
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Age
Inclusion criteria:
Exclusion criteria:
Procedures
Inclusion criteria:
Exclusion criteria:
Providers
Inclusion criteria:
Exclusion criteria:
Selection of catheter insertion site
Complications
Inclusion criteria:
Exclusion criteria:
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Over 2000 patients in Germany
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| Name | Affiliation | Role |
|---|---|---|
| Wolfram Schummer, MD, PhD | Deutsche Interdisziplinäre Vereinigung für Intensiv- und Notfallmedizin | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deutsche Interdisziplinäre Vereinigung für Intensiv- und Notfallmedizin e.V. | Mitte | 10117 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30778648 | Background | 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. | |
| 12646670 | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 2, 2022 | Aug 7, 2022 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 17.05.2022 |
| Experience of the operator | Resident physician/ Specialist doctor | 17.05.2022 |
| Puncture attempts | How many puncture attempts are necessary to achieve a successful CVC | 17.05.2022 |
| Type and caliber of catheter | What catheter types and which caliber in French are being inserted | 17.05.2022 |
| Wire problems/issues | witch and how often do problems with the Seldinger-wire occur | 17.05.2022 |
| Ultrasound assistance | Screening / Online guidance / Short or long axis view | 17.05.2022 |
| CVC tip position | measures to ensure central venous catheter tip position (i.e. CXR, ECG method and ultrasound) | 17.05.2022 |
| 19547936 | 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. |
| 24593804 | 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. |
| 27396261 | Background | Coe AJ. AAGBI Safe vascular access guidelines I. Anaesthesia. 2016 Aug;71(8):985. doi: 10.1111/anae.13553. No abstract available. |
| 27396262 | Background | Bierman S. AAGBI safe vascular access guidelines II. Anaesthesia. 2016 Aug;71(8):985-6. doi: 10.1111/anae.13554. No abstract available. |
| 27981565 | 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. |