German Point Prevalence Study on CVC

NCT ID: NCT04674371

Last Updated: 2022-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

537 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-17

Study Completion Date

2022-05-20

Brief Summary

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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

* 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.

Detailed Description

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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,

1. Only for Screening?
2. 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:

1. by EKG-lead on Pmax or Pmax - x cm (withdroth)
2. by means of transthoracic ultrasound and agitated NaCl solution
3. by means of transesophageal echocardiography and NaCl solution
4. by means of X-ray image
5. 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?

Conditions

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Data Collection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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central venous catheter insertion

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adults
* Young Adults
* Children
* Infants
* Neonates

* Elective central venous access procedures
* Emergency central venous access procedures

* Anesthesiologists
* Internist
* Neurologist
* Surgeon
* Etc.

* 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

* None

Procedures


* None

Providers


* None

Selection of catheter insertion site

* External jugular
* Internal jugular
* Subclavian
* Femoral

Complications


* Infections or other complications not associated with central venous catheterization
* Mechanical injury or trauma not associated with central venous catheterization
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wolfram Schummer, MD, PhD

OTHER

Sponsor Role lead

Responsible Party

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Wolfram Schummer, MD, PhD

PD Dr. med. Dr. med. habil.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Wolfram Schummer, MD, PhD

Role: STUDY_CHAIR

Deutsche Interdisziplinäre Vereinigung für Intensiv- und Notfallmedizin

Locations

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

Mitte, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 30778648 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12646670 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19547936 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24593804 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 27396261 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 27396262 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27981565 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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U1111-1229-1554

Identifier Type: REGISTRY

Identifier Source: secondary_id

DRKS00016855

Identifier Type: -

Identifier Source: org_study_id

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