CLABSI - Central Line Associated Bloodstream InfectionNCT04927325
Erythema at Exit Site & Tablet Camera
A study testing Set of Photos in people with CLABSI - Central Line Associated Bloodstream Infection and CRBSI - Catheter Related Bloodstream Infection, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Background: In critical care medicine central venous catheters play an important role in the source of infections. In the daily routine prior to the diagnosis the suspicion of catheter related infection is discussed in the medical team due to signs of systemic inflammation or exit site infection like erythema… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CLABSI - Central Line Associated Bloodstream Infection, CRBSI - Catheter Related Bloodstream Infection, Digital Technology
- What is being tested?
- Set of Photos
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- 30 Jun 2021to 10 Oct 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
- Adult
- Jugular CVC or Subclavian CVC
- ICU-Admission
Who cannot join
- < 18 years
- Pregnancy/Lactation
- HIV
- neutropenia (<1000/m3)
- hematologic tumor
- dark pigmentation
- prone position within the last 24 hours
- head/neck-area: cancer, operation, burns or radiation, tattoos
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Anesthesia, General Intensive Care and Pain Management,Medical University of Vienna
Vienna, 1090
About this study
Official title: Quantification of Erythema at Exit Site of Central Catheter: Is a Tablet Camera Sufficient?
Background: In critical care medicine central venous catheters play an important role in the source of infections. In the daily routine prior to the diagnosis the suspicion of catheter related infection is discussed in the medical team due to signs of systemic inflammation or exit site infection like erythema, induration or tenderness. However, if an erythema at exit site of a central line can be quantified with a tablet camera, is unknown.
Methods: Standardized set of photos will be taken of 10 central lines with a reddened exit site and 10 catheters without an erythema (as a control over time) with a tablet camera and a single-lens reflex camera. The percentage of usable images between tablet and single-lens reflex camera will be analysed. Furthermore, two independent clinical experts from dermatology will grade blinded de-identied images on a scale from 0 to 4 (0 - no erythema, 1- very faint, 2 - faint, 3 - bright, 4 - very bright).
Objectives: The primary objective of this feasibility study aims to analyze the reliability of a tablet camera as a device for quantification of erythema around an exit site.
- Conditions
- CLABSI - Central Line Associated Bloodstream Infection, CRBSI - Catheter Related Bloodstream Infection, Digital Technology
- Being tested
- Set of Photos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Set of PhotosOther
A standardized set of photos will be taken with a tablet camera, SLR, thermal camera.
| Study group | Role | What they receive |
|---|---|---|
| central line with a reddened exit site | Other | A standardized set of photos will be taken of 10 central lines with an erythema at exit site (visible to the naked eye) Receives: Other: Set of Photos |
| Control Group: central line without a reddened exit site | Other | A standardized set of photos will be taken of 10 newly inserted CVC (as a control over time to evaluate the in-patient redness and the impact of irritation of a CVC) Receives: Other: Set of Photos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of usable images
The percentage of useable images of tablet camera compared with single-lens reflex (SLR) camera will be analysed.
Measured: through study completion, an average of 3 months
Secondary outcomes (1)
Quantification of the exit site with regards to an erythema scale
The secondary objective aims to evaluate the quantification of the exit site regarding to the erythema scale by two independent clinical experts comparing images of tablet and SLR camera.
The erythema will be graded using a visual ordinal scale (grade 0 to grade 4). Grade 0 represents no erythema, whereas grade 4 describes a very bright erythema.
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start30 Jun 2021
- Primary completion10 Oct 2022
- Study completion10 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CLABSI - Central Line Associated Bloodstream InfectionStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 10 central lines with a reddened exit site 10 central lines without a reddened exit site
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Hafner, Medical University of Vienna
- Investigators
- Department of Anaesthesia & General Intensive Care, Study chair, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04927325
- Sponsor's protocol ID
- 1165/2021
- Status last verified
- Dec 2021
- First submitted
- 2 Jun 2021
- Last updated
- 17 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Erythema at Exit Site of Central Catheter: Is a Tablet Camera Sufficient?
- ClinicalTrials.gov ID
- NCT04927325
- Acronym / sponsor ID
- 1165/2021
- Conditions
- CLABSI - Central Line Associated Bloodstream Infection, CRBSI - Catheter Related Bloodstream Infection, Digital Technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 10 Oct 2022 (actual)
- Study completion
- 10 Oct 2022 (actual)
- First posted
- 16 Jun 2021 (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.
Background: In critical care medicine central venous catheters play an important role in the source of infections. In the daily routine prior to the diagnosis the suspicion of catheter related infection is discussed in the medical team due to signs of systemic inflammation or exit site infection like erythema, induration or tenderness. However, if an erythema at exit site of a central line can be quantified with a tablet camera, is unknown.
Methods: Standardized set of photos will be taken of 10 central lines with a reddened exit site and 10 catheters without an erythema (as a control over time) with a tablet camera and a single-lens reflex camera. The percentage of usable images between tablet and single-lens reflex camera will be analysed. Furthermore, two independent clinical experts from dermatology will grade blinded de-identied images on a scale from 0 to 4 (0 - no erythema, 1- very faint, 2 - faint, 3 - bright, 4 - very bright).
Objectives: The primary objective of this feasibility study aims to analyze the reliability of a tablet camera as a device for quantification of erythema around an exit site.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 10 central lines with a reddened exit site 10 central lines without a reddened exit site
| Arm | Type | Receives |
|---|---|---|
| central line with a reddened exit site | Other | Other: Set of PhotosA standardized set of photos will be taken of 10 central lines with an erythema at exit site (visible to the naked eye) |
| Control Group: central line without a reddened exit site | Other | Other: Set of PhotosA standardized set of photos will be taken of 10 newly inserted CVC (as a control over time to evaluate the in-patient redness and the impact of irritation of a CVC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult
- Jugular CVC or Subclavian CVC
- ICU-Admission
Key exclusion criteria (8 listed)
- < 18 years
- Pregnancy/Lactation
- HIV
- neutropenia (<1000/m3)
- hematologic tumor
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 |
|---|---|---|
| Set of PhotosA standardized set of photos will be taken with a tablet camera, SLR, thermal camera. | Other | Control Group: central line without a reddened exit site, central line with a reddened exit site |
Primary outcome
Percentage of usable images
Time frame: through study completion, an average of 3 months
The percentage of useable images of tablet camera compared with single-lens reflex (SLR) camera will be analysed.
1 secondary outcome
Quantification of the exit site with regards to an erythema scale
Time frame: through study completion, an average of 3 months
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 17 Oct 2022.
- 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.
Department of Anaesthesia & General Intensive Care study chair
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Set of Photos in people with CLABSI - Central Line Associated Bloodstream Infection and CRBSI - Catheter Related Bloodstream Infection, run by Medical University of Vienna at 1 site in Austria.
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 8 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 17 Oct 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 Austria. 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?
Percentage of usable images (time frame: through study completion, an average of 3 months). 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 17 Oct 2022.