Erythema at Exit Site & Tablet Camera

Study Overview
=================
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.

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

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

Intervention / Treatment
-----------------
* Other: Set of Photos


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 10 central lines with a reddened exit site 10 central lines without a reddened exit site
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: central line with a reddened exit site<br>A standardized set of photos will be taken of 10 central lines with an erythema at exit site (visible to the naked eye) | Other: Set of Photos<br>* A standardized set of photos will be taken with a tablet camera, SLR, thermal camera.<br>|
| Other: Control Group: central line without a reddened exit site<br>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) | Other: Set of Photos<br>* A standardized set of photos will be taken with a tablet camera, SLR, thermal camera.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of usable images | The percentage of useable images of tablet camera compared with single-lens reflex (SLR) camera will be analysed. | through study completion, an average of 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | through study completion, an average of 3 months |