Erythema at Exit Site & Tablet Camera

NCT ID: NCT04927325

Last Updated: 2022-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-30

Study Completion Date

2022-10-10

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

10 central lines with a reddened exit site 10 central lines without a reddened exit site
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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central line with a reddened exit site

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

Group Type OTHER

Set of Photos

Intervention Type 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

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)

Group Type OTHER

Set of Photos

Intervention Type OTHER

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

Interventions

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Set of Photos

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Christina Hafner

Clinical Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Department of Anaesthesia & General Intensive Care

Role: STUDY_CHAIR

Medical University of Vienna

Locations

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

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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1165/2021

Identifier Type: -

Identifier Source: org_study_id

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