Erythema at Exit Site & Tablet Camera

NCT04927325 | Completed

• 1 other identifier: 1165/2021
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Quantification of the exit site with regards to an erythema scale

  through study completion, an average of 3 months

Study Arms (2)

central line with a reddened exit site

OTHER

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

Control Group: central line without a reddened exit site

OTHER

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

Interventions

Set of Photos OTHER

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

Control Group: central line without a reddened exit site; central line with a reddened exit site

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \< 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

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

Vienna, 1090, Austria

Location

Study Officials

• Department of Anaesthesia & General Intensive Care

  Medical University of Vienna

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Investigator

Model Details: 10 central lines with a reddened exit site 10 central lines without a reddened exit site

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: June 16, 2021
• Study Start: June 30, 2021
• Primary Completion: October 10, 2022
• Study Completion: October 10, 2022
• Last Updated: October 17, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)