Procedural ComplicationNCT06417021
Ergonomics in Ultrasound Procedures
A study testing Frontal Ultrasound Machine and Lateral Ultrasound Machine in people with Procedural Complication and Competence, run by University of Padova at 1 site in Italy.
Trial summary
The study will compare two different positions of the ultrasound machine during simulated CVC positioning. The position of the ultrasound machine will be randomized. Group A will perform the procedure with the ultrasound monitor facing them, while subjects randomized to group B will perform the procedure with the… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Procedural Complication, Competence
- What is being tested?
- Frontal Ultrasound Machine and Lateral Ultrasound Machine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 239 participants
- Where
- 1 siteItaly
- Study dates
- 25 May 2024to 10 Feb 2025
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 'Anesthesia and Intensive Care' and 'Emergency Medicine' residents
- Informed consent
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Position of the Ultrasound Machine in the Placement of the Central Venous Catheter: a Randomized Controlled Study
The study will compare two different positions of the ultrasound machine during simulated CVC positioning.
The position of the ultrasound machine will be randomized. Group A will perform the procedure with the ultrasound monitor facing them, while subjects randomized to group B will perform the procedure with the ultrasound machine positioned at a 90° angle to their visual axis.
Read the detailed description
We will recruit medical trainees affiliated with the 'Anesthesia and Intensive Care' and 'Emergency Medicine' schools. Data collected for each participant will include: age, gender, specialty school, year of specialization training, expertise in using ultrasound for ultrasound-guided procedures. Once informed consent is obtained, subjects will be divided through simple randomization (a list generated in advance with Excel and subjected to the opaque envelope method) into two groups: A and B. All subjects will be asked to perform CVC placement using the simulator through an 'oblique in-plane' approach. Subjects randomized to group A will perform the procedure with the ultrasound monitor facing them, while subjects randomized to group B will perform the procedure with the ultrasound machine positioned at a 90° angle to their visual axis.
- Conditions
- Procedural Complication, Competence
- Being tested
- Frontal Ultrasound Machine, Lateral Ultrasound Machine
- Keywords
- Central Venous Access, Ultrasound, Ergonomics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frontal Ultrasound MachineOther
Ultrasound machine will be placed in a frontal position
Lateral Ultrasound MachineOther
Ultrasound machine will be placed in a lateral position
| Study group | Role | What they receive |
|---|---|---|
| Frontal position of Ultrasound machine (Ergonomic group) | Other | Participants will simulate a CVC positioning keeping the ultrasound machine facing them Receives: Other: Frontal Ultrasound Machine |
| Lateral position (90°) of Ultrasound machine (No Ergonomic group) | Other | Participants will simulate a CVC positioning keeping the ultrasound machine in a lateral position on the same side of the needle. Receives: Other: Lateral Ultrasound Machine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to correct CVC position
Investigators will measure time needed to correctly perform the procedure in seconds. The chronometer will be started when the participant takes the ultrasound probe and will be stopped when the guidewire will be correctly placed
Measured: baseline
Secondary outcomes (3)
Needle tip visualization
Procedure will be recorded as a clip in ultrasound machine. A blind assessor will evaluate the clip using the following scale (1-During the advancement of the needles, only the distortion of the tissue could be observed.
2-Only the tip of the needle was visible. 3-The tip of the needle was visible throughout the advancement, but the body of the needle was only partially visible.
4-The needle was completely visible during its advancement.)
Measured: baseline
Complications
A complication is defined as participants puncturing the arterial vessel of the simulator
Measured: baseline
Success of the procedure
Procedure will be considered successful if participants will be able to insert the guidewire in a 10 minutes timeframe
Measured: 10 minutes from the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start25 May 2024
- Primary completion10 Feb 2025
- Study completion10 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro De Cassai, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06417021
- Sponsor's protocol ID
- 25148/2024
- Status last verified
- Feb 2025
- First submitted
- 9 Apr 2024
- Last updated
- 20 Feb 2025
- 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 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Position of the Ultrasound Machine in the Placement of the Central Venous Catheter: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06417021
- Acronym / sponsor ID
- 25148/2024
- Conditions
- Procedural Complication, Competence
- Keywords
- Central Venous Access, Ultrasound, Ergonomics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 25 May 2024 (actual)
- Primary completion
- 10 Feb 2025 (actual)
- Study completion
- 10 Feb 2025 (actual)
- First posted
- 16 May 2024 (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 study will compare two different positions of the ultrasound machine during simulated CVC positioning.
The position of the ultrasound machine will be randomized. Group A will perform the procedure with the ultrasound monitor facing them, while subjects randomized to group B will perform the procedure with the ultrasound machine positioned at a 90° angle to their visual axis.
Detailed description
We will recruit medical trainees affiliated with the 'Anesthesia and Intensive Care' and 'Emergency Medicine' schools. Data collected for each participant will include: age, gender, specialty school, year of specialization training, expertise in using ultrasound for ultrasound-guided procedures. Once informed consent is obtained, subjects will be divided through simple randomization (a list generated in advance with Excel and subjected to the opaque envelope method) into two groups: A and B. All subjects will be asked to perform CVC placement using the simulator through an 'oblique in-plane' approach. Subjects randomized to group A will perform the procedure with the ultrasound monitor facing them, while subjects randomized to group B will perform the procedure with the ultrasound machine positioned at a 90° angle to their visual axis.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Frontal position of Ultrasound machine (Ergonomic group) | Other | Other: Frontal Ultrasound MachineParticipants will simulate a CVC positioning keeping the ultrasound machine facing them |
| Lateral position (90°) of Ultrasound machine (No Ergonomic group) | Other | Other: Lateral Ultrasound MachineParticipants will simulate a CVC positioning keeping the ultrasound machine in a lateral position on the same side of the needle. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 'Anesthesia and Intensive Care' and 'Emergency Medicine' residents
- Informed consent
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Frontal Ultrasound MachineUltrasound machine will be placed in a frontal position | Other | Frontal position of Ultrasound machine (Ergonomic group) |
| Lateral Ultrasound MachineUltrasound machine will be placed in a lateral position | Other | Lateral position (90°) of Ultrasound machine (No Ergonomic group) |
Primary outcome
Time to correct CVC position
Time frame: baseline
Investigators will measure time needed to correctly perform the procedure in seconds. The chronometer will be started when the participant takes the ultrasound probe and will be stopped when the guidewire will be correctly placed
3 secondary outcomes
Needle tip visualization
Time frame: baseline
Complications
Time frame: baseline
Success of the procedure
Time frame: 10 minutes from the baseline
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 20 Feb 2025.
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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 Frontal Ultrasound Machine and Lateral Ultrasound Machine in people with Procedural Complication and Competence, run by University of Padova at 1 site in Italy.
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 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 20 Feb 2025. 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 Italy. 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?
Time to correct CVC position (time frame: baseline). 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 Feb 2025.