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OpenTrials
Completed

NCT Number: NCT04927325

Erythema at Exit Site & Tablet Camera

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesia, General Intensive Care and Pain Management,Medical University of Vienna

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Set of Photos

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Quantification of the exit site with regards to an erythema scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 16, 2021
Registry last updated
Oct 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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