Erythema at Exit Site & Tablet Camera

Medical University of Vienna

Status: Completed

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

Treatments: Other: Set of Photos

Study type: Interventional

Funder types: Other

Identifiers

NCT04927325

1165/2021

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

central line with a reddened exit site

Other group

Description:

A standardized set of photos will be taken of 10 central lines with an erythema at exit site (visible to the naked eye)

Treatment:

Other: Set of Photos

Control Group: central line without a reddened exit site

Other group

Description:

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)

Treatment:

Other: Set of Photos