Central Venous CatheterNCT04630236
Ultrasound Guided Positioning of Central Venous Catheters
A study testing Ultrasound in people with Central Venous Catheter, run by Asklepios Neurological Clinic Bad Salzhausen at 1 site in Germany.
Trial summary
The current standard for (correct) position control of a central venous catheter (CVC) is X-ray control, which is associated with X-rays for the patient. In some clinics, radiological services are not offered "around the clock". Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Venous Catheter
- What is being tested?
- Ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2021to 9 Aug 2022
- 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
- elective insertion of a central venous catheter.
Who cannot join
- emergency insertion of a central venous catheter
Trial locations and contacts
1 site in 1 country.
About this study
The current standard for (correct) position control of a central venous catheter (CVC) is X-ray control, which is associated with X-rays for the patient. In some clinics, radiological services are not offered "around the clock". Therefore, an alternative that is not burdensome for patients and is available on all sides would be desirable. The possibility of a sonographic CVC position control is to be investigated.
The correct position of a central venous catheter is important. Complications/failure must be detected early/immediately. In addition to the X-ray of the thorax, a position control by means of an ECG derivative (α-card derivative) is available for position control. The method is easy to perform, but an epicardial or an arterial position of the CVC cannot be detected without the use of additional imaging in case of doubt.
For the reasons mentioned above, sonography is a suitable method to show the inflow of injected 0.9% sodium chloride solution into the right atrium, which allows to conclude the correct position of the CVC.
- Conditions
- Central Venous Catheter
- Being tested
- Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDiagnostic test
Using ultrasound control, the central vein catheter is injected with saline solution and the time to detect the saline bolus in the ultrasound is measured.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound | Other | Not described Receives: Diagnostic Test: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
- correlation between the time of detection of the injected saline bolus and radiological position of the central venous catheter
- ultrasound during injection of saline solution into a newly inserted central venous catheter
Measured: up to 5 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start1 Mar 2021
- Primary completion20 Jul 2022
- Study completion9 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Central Venous CatheterStudies 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
- Asklepios Neurological Clinic Bad Salzhausen
- Sponsor type
- University, hospital or other
- Collaborators
- Kerckhoff Klinik
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04630236
- Sponsor's protocol ID
- CVC061120
- Status last verified
- Jul 2022
- First submitted
- 6 Nov 2020
- Last updated
- 11 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schummer W, Schummer C, Schelenz C, Brandes H, Stock U, Muller T, Leder U, Huttemann E. Central venous catheters--the inability of 'intra-atrial ECG' to prove adequate positioning. Br J Anaesth. 2004 Aug;93(2):193-8. doi: 10.1093/bja/aeh191. Epub 2004 Jun 25.
PubMed 15220179Schummer W, Herrmann S, Schummer C, Funke F, Steenbeck J, Fuchs J, Uhlig T, Reinhart K. Intra-atrial ECG is not a reliable method for positioning left internal jugular vein catheters. Br J Anaesth. 2003 Oct;91(4):481-6. doi: 10.1093/bja/aeg208.
PubMed 14504146
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Positioning of Central Venous Catheters
- ClinicalTrials.gov ID
- NCT04630236
- Acronym / sponsor ID
- CVC061120
- Conditions
- Central Venous Catheter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Asklepios Neurological Clinic Bad SalzhausenUniversity, hospital or other
- Collaborators
- Kerckhoff Klinik
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 20 Jul 2022 (actual)
- Study completion
- 9 Aug 2022 (actual)
- First posted
- 16 Nov 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.
The current standard for (correct) position control of a central venous catheter (CVC) is X-ray control, which is associated with X-rays for the patient. In some clinics, radiological services are not offered "around the clock". Therefore, an alternative that is not burdensome for patients and is available on all sides would be desirable. The possibility of a sonographic CVC position control is to be investigated.
The correct position of a central venous catheter is important. Complications/failure must be detected early/immediately. In addition to the X-ray of the thorax, a position control by means of an ECG derivative (α-card derivative) is available for position control. The method is easy to perform, but an epicardial or an arterial position of the CVC cannot be detected without the use of additional imaging in case of doubt.
For the reasons mentioned above, sonography is a suitable method to show the inflow of injected 0.9% sodium chloride solution into the right atrium, which allows to conclude the correct position of the CVC.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound | Other | Diagnostic Test: Ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- elective insertion of a central venous catheter.
Key exclusion criteria (1 listed)
- emergency insertion of a central venous catheter
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 |
|---|---|---|
| UltrasoundUsing ultrasound control, the central vein catheter is injected with saline solution and the time to detect the saline bolus in the ultrasound is measured. | Diagnostic test | Ultrasound |
Primary outcome
- correlation between the time of detection of the injected saline bolus and radiological position of the central venous catheter
Time frame: up to 5 seconds
- ultrasound during injection of saline solution into a newly inserted central venous catheter
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 11 Aug 2022.
- Background: PubMed 15220179Schummer W, Schummer C, Schelenz C, Brandes H, Stock U, Muller T, Leder U, Huttemann E. Central venous catheters--the inability of 'intra-atrial ECG' to prove adequate positioning. Br J Anaesth. 2004 Aug;93(2):193-8. doi: 10.1093/bja/aeh191. Epub 2004 Jun 25.
- Background: PubMed 14504146Schummer W, Herrmann S, Schummer C, Funke F, Steenbeck J, Fuchs J, Uhlig T, Reinhart K. Intra-atrial ECG is not a reliable method for positioning left internal jugular vein catheters. Br J Anaesth. 2003 Oct;91(4):481-6. doi: 10.1093/bja/aeg208.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound in people with Central Venous Catheter, run by Asklepios Neurological Clinic Bad Salzhausen 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 1 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 11 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?
- correlation between the time of detection of the injected saline bolus and radiological position of the central venous catheter (time frame: up to 5 seconds). 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 NCT04630236, which also lists 2 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 11 Aug 2022.