Non-invasive Detection of Driveline Infections in Patients with a Left Ventricular Assist Device
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: LVAD (Left Ventricular Assist Device) Driveline Infection. Basic parameters: 16 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The aim of this single center observational study is to determine the feasibility of using non-invasive imaging methods, including smartphone photography and infrared thermography, for detecting of DLIs in LVAD patients in terms of severity, extent and natural healing process.
Detailed description
Observational data of the driveline exit of LVAD patients will be collected during a follow-up period of 26 weeks. Two non-invasive imaging methods will be used.
Smartphone photos will be taken weekly by the patient during routine wound care in the home environment.
In case the patient is admitted for driveline infection, infrared thermographic (IRT) photography will be used to make thermographic photos of the driveline exit and the abdominal area of the subcutaneous driveline.
Furthermore, existing smartphone images and diagnostic data regarding prior DLI status will be obtained from the electronic patient records.
Imaging data will additionally be retrospectively analyzed using artificial intelligence (AI) and machine learning for the development of a predictive AI model.
Primary outcome measures
- Extent and severity of driveline infections in LVAD patients using non-invasive imaging [Time frame: 26 weeks]
- Driveline exit healing process and risk of infection of the LVAD driveline [Time frame: 26]
Secondary outcome measures (2)
- Sceptic complications [Time frame: 26 weeks]
- Machine learning model for predicting DLIs. [Time frame: 26 weeks]
Eligibility criteria
Inclusion Criteria: Patients age 16 years or older, implanted with an LVAD, followed at Erasmus MC, with access to a smartphone with a built-in camera, who have signed an informed consent for data collection.
Exclusion Criteria: Known cognitive problems, like dementia etc., non-cardiac disease or cardiac diseases resulting in a life expectancy less than 1 years, inability to read or sign the informed consent form.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 1 center
- Erasmus MC — Rotterdam
Identifiers
NCT: NCT06867887 · MEC-2023-0597