Catheter Related ComplicationNCT06109584
Verification of the Correct Insertion of a Central Venous Catheter
A study testing Insertion of central venous catheter in people with Catheter Related Complication, run by Consorci Sanitari de Terrassa at 1 site in Spain.
Trial summary
The investigators propose a prospective diagnostic validity study in which the correct location of the central venous catheter will be verified by ultrasound and then verified by radiography in the same patient, without modifying the usual clinical practice criteria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheter Related Complication
- What is being tested?
- Insertion of central venous catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 1 Aug 2023to 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
- Patients over 18 years of age in whom a decision is made to place a supradiaphragmatic central venous catheter.
- Patients who agree to participate in the study
Who cannot join
- Patients with devices that may interfere with the ultrasound images.
- Patients with poor ultrasound window
- Patients with superior vena cava syndrome
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Consorci Sanitari de Terrassa
Terrassa, Barcelona, 08227
Paula Gil Esteller, +34628467708, gilesteller@gmail.com
About this study
Official title: Verification of the Correct Insertion of a Supradiaphragmatic Central Venous Catheter by a Single Echocardiographic Plane
The investigators propose a prospective diagnostic validity study in which the correct location of the central venous catheter will be verified by ultrasound and then verified by radiography in the same patient, without modifying the usual clinical practice criteria.
- Conditions
- Catheter Related Complication
- Being tested
- Insertion of central venous catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insertion of central venous catheterDevice
Central venous catheter verified by ultrasound and then verified by radiography.
| Study group | Role | What they receive |
|---|---|---|
| CVC location with Rx | Active comparator | After placement of the CVC we will perform the X-ray and subsequent verification of the correct location. Simultaneously, a stopwatch will be started to calculate the time interval until the interpretation of the X-ray by the anesthesiologist. Receives: Device: Insertion of central venous catheter |
| CVC location with echocardiography | Active comparator | Cardiac ultrasound will be performed to visualize the correct position of the CVC tip, and the time until the interpretation of the ultrasound results will also be monitored. Receives: Device: Insertion of central venous catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the incidence of malposition of central venous catheter
Incidence of malposition measured by echocardiography and chest radiography in confirming the correct positioning of the tip of the supradiaphragmatic central venous catheter. Moreover, this check can be performed in a shorter time interval.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start1 Aug 2023
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter Related ComplicationStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- We propose a prospective diagnostic validity study in which the correct location of the central venous catheter will be verified by ultrasound and then verified by radiography in the same patient, without modifying the usual clinical practice criteria.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari de Terrassa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paula Gil Esteller, Consorci Sanitari de Terrassa
- Investigators
- Paula Gil Esteller, MD, Principal investigator, Consorci Sanitari de Terrassa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06109584
- Sponsor's protocol ID
- 02-23-270-088
- Status last verified
- Oct 2023
- First submitted
- 1 Oct 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verification of the Correct Insertion of a Supradiaphragmatic Central Venous Catheter by a Single Echocardiographic Plane
- ClinicalTrials.gov ID
- NCT06109584
- Acronym / sponsor ID
- 02-23-270-088
- Conditions
- Catheter Related Complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Consorci Sanitari de TerrassaUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 31 Oct 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 investigators propose a prospective diagnostic validity study in which the correct location of the central venous catheter will be verified by ultrasound and then verified by radiography in the same patient, without modifying the usual clinical practice criteria.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- We propose a prospective diagnostic validity study in which the correct location of the central venous catheter will be verified by ultrasound and then verified by radiography in the same patient, without modifying the usual clinical practice criteria.
| Arm | Type | Receives |
|---|---|---|
| CVC location with Rx | Active comparator | Device: Insertion of central venous catheterAfter placement of the CVC we will perform the X-ray and subsequent verification of the correct location. Simultaneously, a stopwatch will be started to calculate the time interval until the interpretation of the X-ray by the anesthesiologist. |
| CVC location with echocardiography | Active comparator | Device: Insertion of central venous catheterCardiac ultrasound will be performed to visualize the correct position of the CVC tip, and the time until the interpretation of the ultrasound results will also be monitored. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients over 18 years of age in whom a decision is made to place a supradiaphragmatic central venous catheter.
- Patients who agree to participate in the study
Key exclusion criteria (3 listed)
- Patients with devices that may interfere with the ultrasound images.
- Patients with poor ultrasound window
- Patients with superior vena cava syndrome
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 |
|---|---|---|
| Insertion of central venous catheterCentral venous catheter verified by ultrasound and then verified by radiography. | Device | CVC location with Rx, CVC location with echocardiography |
Primary outcome
To determine the incidence of malposition of central venous catheter
Time frame: Through study completion, an average of 1 year
Incidence of malposition measured by echocardiography and chest radiography in confirming the correct positioning of the tip of the supradiaphragmatic central venous catheter. Moreover, this check can be performed in a shorter time interval.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Individual participant dataSharing planned: Yes. Yes
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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.
Paula Gil Esteller, MD principal investigator
Consorci Sanitari de Terrassa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insertion of central venous catheter in people with Catheter Related Complication, run by Consorci Sanitari de Terrassa at 1 site in Spain.
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 2 inclusion and 3 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 31 Oct 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paula Gil Esteller, MD (+34 628467708, gilesteller@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the incidence of malposition of central venous catheter (time frame: Through study completion, an average of 1 year). 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 31 Oct 2023.