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Erythema at Exit Site & Tablet Camera

Quantification of Erythema at Exit Site of Central Catheter: Is a Tablet Camera Sufficient?

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04927325
Enrollment
20
Registered
2021-06-16
Start date
2021-06-30
Completion date
2022-10-10
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CLABSI - Central Line Associated Bloodstream Infection, CRBSI - Catheter Related Bloodstream Infection, Digital Technology

Brief 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, 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.

Interventions

OTHERSet of Photos

A standardized set of photos will be taken with a tablet camera, SLR, thermal camera.

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

10 central lines with a reddened exit site 10 central lines without a reddened exit site

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult * Jugular CVC or Subclavian CVC * ICU-Admission

Exclusion criteria

* \< 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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of usable imagesthrough study completion, an average of 3 monthsThe percentage of useable images of tablet camera compared with single-lens reflex (SLR) camera will be analysed.

Secondary

MeasureTime frameDescription
Quantification of the exit site with regards to an erythema scalethrough study completion, an average of 3 monthsThe 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.

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026