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Recruiting NCT06838598

Structural and Microbiological Characterization of Arterial Catheter Biofilm in ICU's Patients Using Optical Coherence Tomography

— Observational Biofilms Arterial Catheterization, Peripheral Bacteremia Tomography, Optical Coherence

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
The protocol lists: OCT-BIO-KTA cohort.
Who it may be relevant to
Registry conditions: Biofilms, Arterial Catheterization, Peripheral, Bacteremia, Tomography, Optical Coherence. Basic parameters: from 18 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
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

29.3% of bacteremias in intensive care units (ICU) are linked to vascular devices, including 7.7% to arterial catheters, with an influence on both morbility and mortality. It is now accepted that biofilm as a role on bacterial development on inner surface of vascular devices but there is yet a lack of clinical relevant data documenting a causal relation between biofilm formation and bacteremias. The investigators assume that a better structural and microbiological characterization of arterial catheter biofilm in ICU patients could help preventing bacteremias or have a more specific treatment when it appears.

Interventions

  • Other OCT-BIO-KTA cohort
    Dynamic full-field optical coherence tomography (D-FF-OCT) analysis of arterial catheter sections before microbiological analysis of catheter biofilm

Primary outcome measures

  • Biofilm structure type (ribbon-shaped or mushroom-shaped), measured with D-FF-OCT [Time frame: Outcome measure is assessed 2 days following catheter removal]
Secondary outcome measures (3)
  • Bacterial or fungal indentification [Time frame: Outcome measure is assessed 2 days following catheter removal]
  • Biofilm thickness, measured with D-FF-OCT [Time frame: Outcome measure is assessed 2 days following catheter removal]
  • Biofilm dynamic signal distribution, measured with D-FF-OCT [Time frame: Outcome measure is assessed 2 days following catheter removal]

Eligibility criteria

Inclusion criteria

  • Patient or relative informed of the study and having declared their non-objection
  • Patient over 18 years old
  • Patient hospitalized in ICU with an arterial catheter

Exclusion criteria

  • Patient unable to express consent
  • Patient whose collection of the arterial catheter is impossible or for whom storage at 4°C is impossible
  • Patient with arterial catheter removed outside the usual procedure of the ICU
  • Patient admitted in ICU with an arterial catheter already in place

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
Other

Study locations

France · 2 centers
  • CHU Dijon Bourgogne — Dijon
  • CH Macon — Mâcon

Identifiers

NCT: NCT06838598 · OCT-BIO-KTA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗