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Erythema at Exit Site & Tablet Camera

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Set of Photos
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for CLABSI - Central Line Associated Bloodstream Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

central line with a reddened exit site

Control Group: central line without a reddened exit site

Arm Description

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

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)

Outcomes

Primary Outcome Measures

Percentage of usable images
The percentage of useable images of tablet camera compared with single-lens reflex (SLR) camera will be analysed.

Secondary Outcome Measures

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

Full Information

First Posted
June 2, 2021
Last Updated
October 14, 2022
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT04927325
Brief Title
Erythema at Exit Site & Tablet Camera
Official Title
Quantification of Erythema at Exit Site of Central Catheter: Is a Tablet Camera Sufficient?
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
June 30, 2021 (Actual)
Primary Completion Date
October 10, 2022 (Actual)
Study Completion Date
October 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CLABSI - Central Line Associated Bloodstream Infection, CRBSI - Catheter Related Bloodstream Infection, Digital Technology

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
10 central lines with a reddened exit site 10 central lines without a reddened exit site
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
central line with a reddened exit site
Arm Type
Other
Arm Description
A standardized set of photos will be taken of 10 central lines with an erythema at exit site (visible to the naked eye)
Arm Title
Control Group: central line without a reddened exit site
Arm Type
Other
Arm 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)
Intervention Type
Other
Intervention Name(s)
Set of Photos
Intervention Description
A standardized set of photos will be taken with a tablet camera, SLR, thermal camera.
Primary Outcome Measure Information:
Title
Percentage of usable images
Description
The percentage of useable images of tablet camera compared with single-lens reflex (SLR) camera will be analysed.
Time Frame
through study completion, an average of 3 months
Secondary Outcome Measure Information:
Title
Quantification of the exit site with regards to an erythema scale
Description
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.
Time Frame
through study completion, an average of 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Department of Anaesthesia & General Intensive Care
Organizational Affiliation
Medical University of Vienna
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Anesthesia, General Intensive Care and Pain Management,Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
No

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Erythema at Exit Site & Tablet Camera

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