Digital Technology Clinical Trial
Official title:
Quantification of Erythema at Exit Site of Central Catheter: Is a Tablet Camera Sufficient?
| Verified date | December 2021 |
| Source | Medical University of Vienna |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | October 10, 2022 |
| Est. primary completion date | October 10, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Department of Anesthesia, General Intensive Care and Pain Management,Medical University of Vienna | Vienna |
| Lead Sponsor | Collaborator |
|---|---|
| Medical University of Vienna |
Austria,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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. |
through study completion, an average of 3 months |