- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT04674371
German Point Prevalence Study on CVC
German Point Prevalence Study on Central Venous Catheter
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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,
- Only for Screening?
- 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:
- by EKG-lead on Pmax or Pmax - x cm (withdroth)
- by means of transthoracic ultrasound and agitated NaCl solution
- by means of transesophageal echocardiography and NaCl solution
- by means of X-ray image
- 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?
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
-
-
-
Berlin-Mitte, Duitsland, 10117
- Deutsche Interdisziplinäre Vereinigung für Intensiv- und Notfallmedizin e.V.
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: Cohort
- Tijdsperspectieven: Prospectief
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Patients Demographics
Tijdsspanne: 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
|
17.05.2022
|
|
Complications and malpositions
Tijdsspanne: 17.05.2022-20.05.2022
|
Which complications and malpositions occur within 72 h
|
17.05.2022-20.05.2022
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Percentage of the emergency procedure
Tijdsspanne: 17.05.2022
|
How many emergency patients will be included in the study
|
17.05.2022
|
|
Distribution of the vessel sites und sides
Tijdsspanne: 17.05.2022
|
distribution of the punctured vessels (external jugular, internal jugular, subclavian, femoral ) and that of the respective sides |
17.05.2022
|
|
Experience of the operator
Tijdsspanne: 17.05.2022
|
Resident physician/ Specialist doctor
|
17.05.2022
|
|
Puncture attempts
Tijdsspanne: 17.05.2022
|
How many puncture attempts are necessary to achieve a successful CVC
|
17.05.2022
|
|
Type and caliber of catheter
Tijdsspanne: 17.05.2022
|
What catheter types and which caliber in French are being inserted
|
17.05.2022
|
|
Wire problems/issues
Tijdsspanne: 17.05.2022
|
witch and how often do problems with the Seldinger-wire occur
|
17.05.2022
|
|
Ultrasound assistance
Tijdsspanne: 17.05.2022
|
Screening / Online guidance / Short or long axis view
|
17.05.2022
|
|
CVC tip position
Tijdsspanne: 17.05.2022
|
measures to ensure central venous catheter tip position (i.e.
CXR, ECG method and ultrasound)
|
17.05.2022
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie stoel: Wolfram Schummer, MD, PhD, Deutsche Interdisziplinäre Vereinigung für Intensiv- und Notfallmedizin
Publicaties en nuttige links
Algemene publicaties
- 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.
- 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.
- 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.
- 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.
- Coe AJ. AAGBI Safe vascular access guidelines I. Anaesthesia. 2016 Aug;71(8):985. doi: 10.1111/anae.13553.
- Bierman S. AAGBI safe vascular access guidelines II. Anaesthesia. 2016 Aug;71(8):985-6. doi: 10.1111/anae.13554.
- 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.
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
- Centraal veneuze katheter
- centrale veneuze lijn
- 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
- Mensen
- Adults, Adolescents
Andere studie-ID-nummers
- DRKS00016855
- U1111-1229-1554 (Register-ID: World Health Organization [WHO] Registry Network)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .