Medical ImagingK-T-CONCT05692310
Study of the Effectiveness of Central Line Placement Using an Ultraportable Ultrasound Device
A study testing placing a standard central venous line and placement of a central venous line using an ultraportable ultrasound device in people with Medical Imaging, run by Centre Chirurgical Marie Lannelongue at 1 site in France.
Trial summary
The placement of a catheter in a large-caliber vein is sometimes necessary for the administration of treatments or the monitoring of a patient. This may be associated with complications during its realization, such as the puncture of an adjacent artery with possible formation of a hematoma or the puncture of the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medical Imaging
- What is being tested?
- placing a standard central venous line and placement of a central venous line using an ultraportable ultrasound device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 238 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2023to 1 Aug 2024
- 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
- Age ≥ 18 years
- Patients scheduled to have a right or left jugular central venous line placed preoperatively or in the ICU .
- Patient with free, informed and express consent or emergency procedure
Who cannot join
- Absolute emergency not allowing randomization
- Pregnant woman
- Patient with suspected or proven jugular thrombosis at the insertion site
- Change of central venous line on guidewire
- Operator with no experience in central venous line placement under ultrasound
- contraindication to the placement of a jugular central venous line
Trial locations and contacts
1 site in 1 country.
About this study
The placement of a catheter in a large-caliber vein is sometimes necessary for the administration of treatments or the monitoring of a patient. This may be associated with complications during its realization, such as the puncture of an adjacent artery with possible formation of a hematoma or the puncture of the pleura with creation of a pneumothorax. These complications may be favored by variations in the anatomy. The use of ultrasound allows visualization of the vessels, its adjacent structures and the puncture needle along its path.
The contribution of ultrasound with the technique of venipuncture under ultrasound guidance is to date the best means of preventing complications by reducing the risk of early mechanical complications by a factor of 5 to 10 according to the studies. The retrospective, multicenter, observational study recently published by Björkander et al reported the experience of 8 Swedish hospitals with 14243 central venous catheter placements, 58% of which were in the internal jugular vein. Nearly one catheter in two was placed with the use of ultrasound (49%). One hundred and eighteen mechanical complications were recorded, of which 23 were considered serious, including 21 pneumothoraxes and 2 severe hemorrhages. Lack of ultrasound use was found to be an independent risk factor for complications in multivariate analysis by logistic regression. Despite a high level of evidence in the scientific literature on the contribution of ultrasound guidance for the placement of central venous catheters, and the recommendations of national and international learned societies published before the start of this study, almost one patient in two had not yet benefited from this technique, which could nevertheless greatly reduce the incidence of early mechanical complications.
The recent introduction of ultra-portable ultrasound scanners could encourage the generalization of the use of ultrasound, given their reduced cost. The hypothesis of the research is that the placement of a central venous catheter is similar whether the ultrasound machine is an ultra-portable ultrasound machine or a conventional ultrasound machine
- Conditions
- Medical Imaging
- Being tested
- placing a standard central venous line, placement of a central venous line using an ultraportable ultrasound device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placing a standard central venous lineOther
Patients will benefit from the technique of central venous line placement by conventional ultrasound.
placement of a central venous line using an ultraportable ultrasound deviceOther
Patients will have a central venous line placed using an ultraportable ultrasound device
| Study group | Role | What they receive |
|---|---|---|
| Patients will have a central venous line placed using an ultraportable ultrasound device. | Experimental | Not described Receives: Other: placement of a central venous line using an ultraportable ultrasound device |
| Patients will benefit from the technique of central venous line placement by conventional ultrasound | Sham comparator | Not described Receives: Other: placing a standard central venous line |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of the procedure
the time in seconds between the beginning of the ultrasonographic scan after placement of the sterile protection device and the beginning of fixation of the catheter to the skin after ultrasound verification confirming its correct position.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start1 Feb 2023 (estimated)
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical ImagingStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 238 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Chirurgical Marie Lannelongue
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05692310
- Sponsor's protocol ID
- 2021-A02935-36
- Acronym
- K-T-CO
- Status last verified
- Jan 2023
- First submitted
- 11 Jan 2023
- Last updated
- 20 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effectiveness of Central Line Placement Using an Ultraportable Ultrasound Device
- ClinicalTrials.gov ID
- NCT05692310
- Acronym / sponsor ID
- K-T-CO / 2021-A02935-36
- Conditions
- Medical Imaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 238 participants (estimated)
- Lead sponsor
- Centre Chirurgical Marie LannelongueUniversity, hospital or other
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 20 Jan 2023 (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 placement of a catheter in a large-caliber vein is sometimes necessary for the administration of treatments or the monitoring of a patient. This may be associated with complications during its realization, such as the puncture of an adjacent artery with possible formation of a hematoma or the puncture of the pleura with creation of a pneumothorax. These complications may be favored by variations in the anatomy. The use of ultrasound allows visualization of the vessels, its adjacent structures and the puncture needle along its path.
The contribution of ultrasound with the technique of venipuncture under ultrasound guidance is to date the best means of preventing complications by reducing the risk of early mechanical complications by a factor of 5 to 10 according to the studies. The retrospective, multicenter, observational study recently published by Björkander et al reported the experience of 8 Swedish hospitals with 14243 central venous catheter placements, 58% of which were in the internal jugular vein. Nearly one catheter in two was placed with the use of ultrasound (49%). One hundred and eighteen mechanical complications were recorded, of which 23 were considered serious, including 21 pneumothoraxes and 2 severe hemorrhages. Lack of ultrasound use was found to be an independent risk factor for complications in multivariate analysis by logistic regression. Despite a high level of evidence in the scientific literature on the contribution of ultrasound guidance for the placement of central venous catheters, and the recommendations of national and international learned societies published before the start of this study, almost one patient in two had not yet benefited from this technique, which could nevertheless greatly reduce the incidence of early mechanical complications.
The recent introduction of ultra-portable ultrasound scanners could encourage the generalization of the use of ultrasound, given their reduced cost. The hypothesis of the research is that the placement of a central venous catheter is similar whether the ultrasound machine is an ultra-portable ultrasound machine or a conventional ultrasound machine
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients will have a central venous line placed using an ultraportable ultrasound device. | Experimental | Other: placement of a central venous line using an ultraportable ultrasound device |
| Patients will benefit from the technique of central venous line placement by conventional ultrasound | Sham comparator | Other: placing a standard central venous line |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Patients scheduled to have a right or left jugular central venous line placed preoperatively or in the ICU .
- Patient with free, informed and express consent or emergency procedure
Key exclusion criteria (6 listed)
- Absolute emergency not allowing randomization
- Pregnant woman
- Patient with suspected or proven jugular thrombosis at the insertion site
- Change of central venous line on guidewire
- Operator with no experience in central venous line placement under ultrasound
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 |
|---|---|---|
| placing a standard central venous linePatients will benefit from the technique of central venous line placement by conventional ultrasound. | Other | Patients will benefit from the technique of central venous line placement by conventional ultrasound |
| placement of a central venous line using an ultraportable ultrasound devicePatients will have a central venous line placed using an ultraportable ultrasound device | Other | Patients will have a central venous line placed using an ultraportable ultrasound device. |
Primary outcome
length of the procedure
Time frame: 1 day
the time in seconds between the beginning of the ultrasonographic scan after placement of the sterile protection device and the beginning of fixation of the catheter to the skin after ultrasound verification confirming its correct position.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing placing a standard central venous line and placement of a central venous line using an ultraportable ultrasound device in people with Medical Imaging, run by Centre Chirurgical Marie Lannelongue at 1 site in France.
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 6 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: status not confirmed, as of the sponsor's last update on 20 Jan 2023. 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 France. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jacques THES, MD (0140948857, jthes@ghpsj.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
length of the procedure (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2023.