Erythema at Exit Site & Tablet Camera

Not Applicable

Completed

• Conditions: CLABSI - Central Line Associated Bloodstream Infection; Digital Technology; CRBSI - Catheter Related Bloodstream Infection
• Interventions: Other: Set of Photos

• Registration Number: NCT04927325
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-02
• Study First Submitted QC: 2021-06-14
• Study First Posted: 2021-06-16
• Study Start: 2021-06-30
• Status Verified: 2021-12
• Primary Completion: 2022-10-10
• Study Completion: 2022-10-10
• Last Update Submitted: 2022-10-14
• Last Update Posted: 2022-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
central line with a reddened exit site	Set of Photos	A 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	Set of Photos	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)

Primary Outcome Measures

Name	Time	Method
Percentage of usable images	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.

Secondary Outcome Measures

Name	Time	Method
Quantification of the exit site with regards to an erythema scale	through study completion, an average of 3 months	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.

Trial Locations

Locations (1)

Department of Anesthesia, General Intensive Care and Pain Management,Medical University of Vienna; 🇦🇹 Vienna, Austria