Data Collection Clinical Trial
Official title:
German Point Prevalence Study on Central Venous Catheter
Verified date | May 2022 |
Source | Deutsche Interdisziplinäre Vereinigung für Intensiv- und Notfallmedizin |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Deutsche Interdisziplinäre Vereinigung für Intensiv- und Notfallmedizin e.V. | Berlin-Mitte |
Lead Sponsor | Collaborator |
---|---|
Wolfram Schummer, MD, PhD |
Germany,
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
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 |
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