Non-invasive Detection of Driveline Infections in Patients with a Left Ventricular Assist Device (DRIVE-ID)
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About
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.
Full 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.
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Inclusion and exclusion 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.
Trial design
70 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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