- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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?
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
-
-
-
Berlin-Mitte, Germania, 10117
- Deutsche Interdisziplinäre Vereinigung für Intensiv- und Notfallmedizin e.V.
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Coorte
- Prospettive temporali: Prospettiva
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Patients Demographics
Lasso di tempo: 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
Lasso di tempo: 17.05.2022-20.05.2022
|
Which complications and malpositions occur within 72 h
|
17.05.2022-20.05.2022
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Percentage of the emergency procedure
Lasso di tempo: 17.05.2022
|
How many emergency patients will be included in the study
|
17.05.2022
|
|
Distribution of the vessel sites und sides
Lasso di tempo: 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
Lasso di tempo: 17.05.2022
|
Resident physician/ Specialist doctor
|
17.05.2022
|
|
Puncture attempts
Lasso di tempo: 17.05.2022
|
How many puncture attempts are necessary to achieve a successful CVC
|
17.05.2022
|
|
Type and caliber of catheter
Lasso di tempo: 17.05.2022
|
What catheter types and which caliber in French are being inserted
|
17.05.2022
|
|
Wire problems/issues
Lasso di tempo: 17.05.2022
|
witch and how often do problems with the Seldinger-wire occur
|
17.05.2022
|
|
Ultrasound assistance
Lasso di tempo: 17.05.2022
|
Screening / Online guidance / Short or long axis view
|
17.05.2022
|
|
CVC tip position
Lasso di tempo: 17.05.2022
|
measures to ensure central venous catheter tip position (i.e.
CXR, ECG method and ultrasound)
|
17.05.2022
|
Collaboratori e investigatori
Sponsor
Investigatori
- Cattedra di studio: Wolfram Schummer, MD, PhD, Deutsche Interdisziplinäre Vereinigung für Intensiv- und Notfallmedizin
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
- Catetere venoso centrale
- linea venosa centrale
- 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
- Umani
- Adults, Adolescents
Altri numeri di identificazione dello studio
- DRKS00016855
- U1111-1229-1554 (Identificatore di registro: World Health Organization [WHO] Registry Network)
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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