Central Venous CatheterizationCJVClumenNCT06375252
Evaluation of Central Jugular Vein Catheter Lumen Holder Design and Ergonomic Use
A study testing Central Jugular Vein Catheter Lumen Holder Apparatus in people with Central Venous Catheterization, run by Saglik Bilimleri Universitesi.
Trial summary
The aim of this study was to evaluate the design and ergonomic use of central jugular vein catheter lumen holder. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Central Venous Catheterization
- What is being tested?
- Central Jugular Vein Catheter Lumen Holder Apparatus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 19 Apr 2024to 30 May 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being a healthy individual over the age of 18
- Not having had a central jugular vein catheter inserted before for any reason (no experience)
- Being literate
- Voluntarily agreeing to participate in the research
- Being able to carry out daily life activities individually
Who cannot join
- Leaving work voluntarily
- Limitation in the head and neck area
About this study
The aim of this study was to evaluate the design and ergonomic use of central jugular vein catheter lumen holder.
Read the detailed description
Central venous catheterisation is one of the invasive procedures commonly used in the treatment and care of patients in internal and surgical clinics and generally in intensive care units and in the follow-up of patients to be operated. Central venous catheters (CVC) are indispensable diagnostic and therapeutic applications in modern medicine. It is a practical method used in cases where venous vessels cannot be used.
Central venous catheterisation is a cannula inserted into the subclavian, jugular or femoral vein. Nurses are responsible for the care and daily control of central venous catheters inserted by physicians. Central venous catheterisation is widely used by nurses in clinical wards, intensive care units and during surgical procedures for many indications such as monitoring, drug administration and parenteral nutrition. Subclavian vein and jugular vein are most commonly used for this purpose. Many complications such as haemothorax, pneumothorax, malposition, air embolism and infection may develop during CVC applications. The role of the nurse is very important in the determination of CVC complications.
In terms of the individual with a central vein catheter, it constitutes a situation where the individual is worried about a catheter placed in his/her body and needs to be sensitive to the area where it is placed. They should be careful while performing daily life activities with the catheter. The presence of the central jugular vein catheter in the neck area affects the head position, and the sagging of the catheter lumens on the dressing causes skin sensitivity.
Individuals with central jugular vein catheters experience some problems such as discomfort due to sagging of the catheter lumens, inability to move comfortably in head and neck movements and sagging of the catheter lumens. The aim of this study was to develop an innovative design of central jugular vein catheter lumen holder to ensure the position, fixation and comfort efficiency of the central jugular vein catheter and to evaluate its ergonomic use.
- Conditions
- Central Venous Catheterization
- Being tested
- Central Jugular Vein Catheter Lumen Holder Apparatus
- Keywords
- Design, Equipment, Nursing Research, Central Venous Catheterizations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Central Jugular Vein Catheter Lumen Holder ApparatusOther
Participants will experience the central jugular vein catheter lumen holder apparatus, perform walking, sitting, supine, right and left side lying activities and fill out the evaluation forms prepared by the researcher. They will then experience the same activities without the apparatus.
| Study group | Role | What they receive |
|---|---|---|
| intervention-control group | Experimental | Participants assigned to the intervention-control group of the study performed activities using the central jugular vein catheter lumen retainer apparatus. Receives: Other: Central Jugular Vein Catheter Lumen Holder Apparatus |
| control-intervention group | No intervention | Participants in the control-intervention group first performed the activities without the central jugular vein catheter lumen retainer apparatus, and then performed the activities with the apparatus. |
What is being measured
The primary outcome is the main question the study is designed to answer.
demographic information
Contains participant identifying information
Measured: 10 minutes
Secondary outcomes (1)
comfort effect
The participant's comfort level is evaluated with Visual Analog Scale.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start19 Apr 2024 (estimated)
- Primary completion16 May 2024 (estimated)
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Venous CatheterizationStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Özkan, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06375252
- Sponsor's protocol ID
- sbughfyaseminozkan1985
- Acronym
- CJVClumen
- Status last verified
- Apr 2024
- First submitted
- 16 Apr 2024
- Last updated
- 19 Apr 2024
- 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 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Central Jugular Vein Catheter Lumen Holder Design and Ergonomic Use
- ClinicalTrials.gov ID
- NCT06375252
- Acronym / sponsor ID
- CJVClumen / sbughfyaseminozkan1985
- Conditions
- Central Venous Catheterization
- Keywords
- Design, Equipment, Nursing Research, Central Venous Catheterizations
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 19 Apr 2024 (estimated)
- Primary completion
- 16 May 2024 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 19 Apr 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 aim of this study was to evaluate the design and ergonomic use of central jugular vein catheter lumen holder.
Detailed description
Central venous catheterisation is one of the invasive procedures commonly used in the treatment and care of patients in internal and surgical clinics and generally in intensive care units and in the follow-up of patients to be operated. Central venous catheters (CVC) are indispensable diagnostic and therapeutic applications in modern medicine. It is a practical method used in cases where venous vessels cannot be used.
Central venous catheterisation is a cannula inserted into the subclavian, jugular or femoral vein. Nurses are responsible for the care and daily control of central venous catheters inserted by physicians. Central venous catheterisation is widely used by nurses in clinical wards, intensive care units and during surgical procedures for many indications such as monitoring, drug administration and parenteral nutrition. Subclavian vein and jugular vein are most commonly used for this purpose. Many complications such as haemothorax, pneumothorax, malposition, air embolism and infection may develop during CVC applications. The role of the nurse is very important in the determination of CVC complications.
In terms of the individual with a central vein catheter, it constitutes a situation where the individual is worried about a catheter placed in his/her body and needs to be sensitive to the area where it is placed. They should be careful while performing daily life activities with the catheter. The presence of the central jugular vein catheter in the neck area affects the head position, and the sagging of the catheter lumens on the dressing causes skin sensitivity.
Individuals with central jugular vein catheters experience some problems such as discomfort due to sagging of the catheter lumens, inability to move comfortably in head and neck movements and sagging of the catheter lumens. The aim of this study was to develop an innovative design of central jugular vein catheter lumen holder to ensure the position, fixation and comfort efficiency of the central jugular vein catheter and to evaluate its ergonomic use.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention-control group | Experimental | Other: Central Jugular Vein Catheter Lumen Holder ApparatusParticipants assigned to the intervention-control group of the study performed activities using the central jugular vein catheter lumen retainer apparatus. |
| control-intervention group | No intervention | –Participants in the control-intervention group first performed the activities without the central jugular vein catheter lumen retainer apparatus, and then performed the activities with the apparatus. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being a healthy individual over the age of 18
- Not having had a central jugular vein catheter inserted before for any reason (no experience)
- Being literate
- Voluntarily agreeing to participate in the research
- Being able to carry out daily life activities individually
Key exclusion criteria (2 listed)
- Leaving work voluntarily
- Limitation in the head and neck area
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 |
|---|---|---|
| Central Jugular Vein Catheter Lumen Holder ApparatusParticipants will experience the central jugular vein catheter lumen holder apparatus, perform walking, sitting, supine, right and left side lying activities and fill out the evaluation forms prepared by the researcher. They will then experience the same activities without the apparatus. | Other | intervention-control group |
Primary outcome
demographic information
Time frame: 10 minutes
Contains participant identifying information
1 secondary outcome
comfort effect
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Central Jugular Vein Catheter Lumen Holder Apparatus in people with Central Venous Catheterization, run by Saglik Bilimleri Universitesi.
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 5 inclusion and 2 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 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
demographic information (time frame: 10 minutes). 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 19 Apr 2024.