Central Venous CatheterizationNCT02661607
Point of Care Echocardiography Versus Chest Radiography for the Assessment of Central Venous Catheter Placement
A study testing Point of care echocardiography, Central venous catheter placement and Chest radiography in people with Central Venous Catheterization and Ultrasound, run by University of Göttingen at 1 site in Germany.
Trial summary
A prospective study to compare the use of point of care echocardiography versus routine chest radiography for the assessment of central venous catheter placement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Venous Catheterization, Ultrasound, Emergency Medicine
- What is being tested?
- Point of care echocardiography, Central venous catheter placement and Chest radiography
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2014to Apr 2016
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who require central venous catheterization in critical care environments (ICU, IMC)
- patients (or legal guardian) who provide written informed consents
- patients aged 18 years or older
Who cannot join
- patients who are unable/unwilling to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Study to Compare Point of Care Echocardiography Versus Chest Radiography for the Assessment of Central Venous Catheter Placement in Critical Care Environments
A prospective study to compare the use of point of care echocardiography versus routine chest radiography for the assessment of central venous catheter placement.
- Being tested
- Point of care echocardiography, Central venous catheter placement, Chest radiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point of care echocardiographyProcedure or surgery
Point of echocardiography is performed after routine placement of central venous catheterization and compared with routine chest radiography
Central venous catheter placementDevice
Central venous catheter placement is performed as per local guidelines in critically ill patients
Chest radiographyProcedure or surgery
Routine chest radiography is performed after central venous catheter placement in critically ill patients
| Study group | Role | What they receive |
|---|---|---|
| Point of care echocardiography after central venous catheter | Other | Point of care echocardiography plus chest radiography Receives: Procedure: Point of care echocardiography; Device: Central venous catheter placement; Procedure: Chest radiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequate placement of the central venous catheter
Participants will be followed for the period after the intervention to assess correct placement, an expected average of 2 hours
Measured: 2 hours
Secondary outcomes (4)
Time needed for the intervention (bedside echocardiography)
Time of the procedure will be measured, an expected average of 5 minutes
Measured: 5 Minutes
Performance of residents as assessed by the time needed to perform the echocardiography
Time needed to perform the echocardiography will be measured with an expected average of 5 minutes
Measured: 5 Minutes
Time needed for chest radiography to be performed
Time will be measured after requesting chest radiography via telephone until chest radiographs are available for review, an expected average of 2 hours
Measured: 2 hours
Adverse Events
Patients will be followed as per local guidelines to detect complications by central venous catheter placement, usual time Frame of 24 hours (e. g. pneumothorax from cvc placement)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2016 (estimated)
- Study startOct 2014
- Primary completionJan 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Central Venous CatheterizationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Göttingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Korsten, University of Göttingen
- Investigators
- Peter Korsten, MD, Principal investigator, University Medical Center Göttingen, Department of Nephrology and Rheumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02661607
- Sponsor's protocol ID
- 1/3/14
- Status last verified
- Jul 2019
- First submitted
- 17 Jun 2015
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Korsten P, Mavropoulou E, Wienbeck S, Ellenberger D, Patschan D, Zeisberg M, Vasko R, Tampe B, Muller GA. The "rapid atrial swirl sign" for assessing central venous catheters: Performance by medical residents after limited training. PLoS One. 2018 Jul 16;13(7):e0199345. doi: 10.1371/journal.pone.0199345. eCollection 2018.
PubMed 30011285
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Compare Point of Care Echocardiography Versus Chest Radiography for the Assessment of Central Venous Catheter Placement in Critical Care Environments
- ClinicalTrials.gov ID
- NCT02661607
- Acronym / sponsor ID
- 1/3/14
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of GöttingenUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 22 Jan 2016 (estimated)
- 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.
A prospective study to compare the use of point of care echocardiography versus routine chest radiography for the assessment of central venous catheter placement.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Point of care echocardiography after central venous catheter | Other | Procedure: Point of care echocardiography, Device: Central venous catheter placement, Procedure: Chest radiographyPoint of care echocardiography plus chest radiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients who require central venous catheterization in critical care environments (ICU, IMC)
- patients (or legal guardian) who provide written informed consents
- patients aged 18 years or older
Key exclusion criteria (1 listed)
- patients who are unable/unwilling to give informed consent
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 |
|---|---|---|
| Point of care echocardiographyPoint of echocardiography is performed after routine placement of central venous catheterization and compared with routine chest radiography | Procedure or surgery | Point of care echocardiography after central venous catheter |
| Central venous catheter placementCentral venous catheter placement is performed as per local guidelines in critically ill patients | Device | Point of care echocardiography after central venous catheter |
| Chest radiographyRoutine chest radiography is performed after central venous catheter placement in critically ill patients | Procedure or surgery | Point of care echocardiography after central venous catheter |
Primary outcome
Adequate placement of the central venous catheter
Time frame: 2 hours
Participants will be followed for the period after the intervention to assess correct placement, an expected average of 2 hours
4 secondary outcomes
Time needed for the intervention (bedside echocardiography)
Time frame: 5 Minutes
Performance of residents as assessed by the time needed to perform the echocardiography
Time frame: 5 Minutes
Time needed for chest radiography to be performed
Time frame: 2 hours
Adverse Events
Time frame: 24 hours
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 23 Jul 2019.
- Derived from this study: PubMed 30011285Korsten P, Mavropoulou E, Wienbeck S, Ellenberger D, Patschan D, Zeisberg M, Vasko R, Tampe B, Muller GA. The "rapid atrial swirl sign" for assessing central venous catheters: Performance by medical residents after limited training. PLoS One. 2018 Jul 16;13(7):e0199345. doi: 10.1371/journal.pone.0199345. eCollection 2018.
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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.
Peter Korsten, MD principal investigator
University Medical Center Göttingen, Department of Nephrology and Rheumatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Point of care echocardiography, Central venous catheter placement and Chest radiography in people with Central Venous Catheterization and Ultrasound, run by University of Göttingen 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 3 inclusion and 1 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 23 Jul 2019. 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?
Adequate placement of the central venous catheter (time frame: 2 hours). 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 NCT02661607, which also lists 1 linked publication.
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 23 Jul 2019; AzTrials last refreshed its copy on 8 Nov 2026.