Data CollectionNCT04674371
German Point Prevalence Study on CVC
An observational study of Data Collection, run by Wolfram Schummer, MD, PhD at 1 site in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Data Collection
- What is being tested?
- central venous catheter insertion
- How many people
- 537 participants
- Where
- 1 siteGermany
- Study dates
- 17 May 2022to 20 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Over 2000 patients in Germany
Who may be able to join
- Adults
- Young Adults
- Children
- Infants
- Neonates
- Elective central venous access procedures
Show all 29Show fewer
- 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
Who cannot join
- None
- Procedures
- None
- Providers
- None
- Selection of catheter insertion site
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Deutsche Interdisziplinäre Vereinigung für Intensiv- und Notfallmedizin e.V.
Mitte, 10117
About this study
Official title: 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.
Read more
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.
Read the detailed description
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?
- Conditions
- Data Collection
- Being tested
- central venous catheter insertion
- Keywords
- Central venous catheter, central venous line, 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, Humans, Adults, Adolescents
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
central venous catheter insertionOther
Every operator should perform the CVC Insertion Procedure according to his common clinical practice.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 17.05.2022
Complications and malpositions
Which complications and malpositions occur within 72 h
Measured: 17.05.2022-20.05.2022
Secondary outcomes (8)
Percentage of the emergency procedure
How many emergency patients will be included in the study
Measured: 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
Measured: 17.05.2022
Experience of the operator
Resident physician/ Specialist doctor
Measured: 17.05.2022
Puncture attempts
How many puncture attempts are necessary to achieve a successful CVC
Measured: 17.05.2022
Type and caliber of catheter
What catheter types and which caliber in French are being inserted
Measured: 17.05.2022
Wire problems/issues
witch and how often do problems with the Seldinger-wire occur
Measured: 17.05.2022
Ultrasound assistance
Screening / Online guidance / Short or long axis view
Measured: 17.05.2022
CVC tip position
measures to ensure central venous catheter tip position (i.e. CXR, ECG method and ultrasound)
Measured: 17.05.2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start17 May 2022
- Primary completion20 May 2022
- Study completion20 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Data CollectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 537 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wolfram Schummer, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wolfram Schummer, MD, PhD, Deutsche Interdisziplinäre Vereinigung für Intensiv- und Notfallmedizin
- Investigators
- Wolfram Schummer, MD, PhD, Study chair, Deutsche Interdisziplinäre Vereinigung für Intensiv- und Notfallmedizin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04674371
- Sponsor's protocol ID
- DRKS00016855
- Other IDs
- U1111-1229-1554
- Status last verified
- May 2022
- First submitted
- 13 Dec 2020
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30778648McGee 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.
PubMed 12646670Schummer 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.
PubMed 19547936Frykholm 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.
PubMed 24593804Coe AJ. AAGBI Safe vascular access guidelines I. Anaesthesia. 2016 Aug;71(8):985. doi: 10.1111/anae.13553. No abstract available.
PubMed 27396261Bierman S. AAGBI safe vascular access guidelines II. Anaesthesia. 2016 Aug;71(8):985-6. doi: 10.1111/anae.13554. No abstract available.
PubMed 27396262Lathey 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.
PubMed 27981565
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- German Point Prevalence Study on Central Venous Catheter
- ClinicalTrials.gov ID
- NCT04674371
- Acronym / sponsor ID
- DRKS00016855
- Conditions
- Data Collection
- Keywords
- Central venous catheter, central venous line, Catheterization, Central Venous / access, Catheterization, Central Venous / methods, Catheterization, Central Venous / instrumentation, Catheterization, Central Venous / adverse effects, Placement of larger catheters, Insertion of CVCs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 537 participants (actual)
- Lead sponsor
- Wolfram Schummer, MD, PhDUniversity, hospital or other
- Study start
- 17 May 2022 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 19 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Over 2000 patients in Germany
Key inclusion criteria (29 listed)
Key exclusion criteria (13 listed)
- Procedures
- Providers
- Selection of catheter insertion site
- External jugular
- Internal jugular
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| central venous catheter insertionEvery operator should perform the CVC Insertion Procedure according to his common clinical practice. | Other | – |
Primary outcome
Patients Demographics
Time frame: 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
Complications and malpositions
Time frame: 17.05.2022-20.05.2022
Which complications and malpositions occur within 72 h
8 secondary outcomes
Percentage of the emergency procedure
Time frame: 17.05.2022
Distribution of the vessel sites und sides
Time frame: 17.05.2022
Experience of the operator
Time frame: 17.05.2022
Puncture attempts
Time frame: 17.05.2022
Type and caliber of catheter
Time frame: 17.05.2022
Wire problems/issues
Time frame: 17.05.2022
Ultrasound assistance
Time frame: 17.05.2022
CVC tip position
Time frame: 17.05.2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Background: PubMed 30778648Schmidt 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.
- Background: PubMed 12646670McGee 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.
- Background: PubMed 19547936Schummer 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.
- Background: PubMed 24593804Frykholm 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.
- Background: PubMed 27396261Coe AJ. AAGBI Safe vascular access guidelines I. Anaesthesia. 2016 Aug;71(8):985. doi: 10.1111/anae.13553. No abstract available.
- Background: PubMed 27396262Bierman S. AAGBI safe vascular access guidelines II. Anaesthesia. 2016 Aug;71(8):985-6. doi: 10.1111/anae.13554. No abstract available.
- Background: PubMed 27981565Lathey 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wolfram Schummer, MD, PhD study chair
Deutsche Interdisziplinäre Vereinigung für Intensiv- und Notfallmedizin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Data Collection, run by Wolfram Schummer, MD, PhD at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 29 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients Demographics (time frame: 17.05.2022). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04674371, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2022; AzTrials last refreshed its copy on 27 Oct 2026.