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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06838598
Acronym
OCT-BIO-KTA
Enrollment
60
Registered
2025-02-20
Start date
2024-06-03
Completion date
2027-12-01
Last updated
2026-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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

OTHEROCT-BIO-KTA cohort

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

Sponsors

Centre Hospitalier William Morey - Chalon sur Saône
Lead SponsorOTHER
Centre Hospitalier Universitaire Dijon
CollaboratorOTHER
Centre Hospitalier Macon
CollaboratorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Biofilm structure type (ribbon-shaped or mushroom-shaped), measured with D-FF-OCTOutcome measure is assessed 2 days following catheter removalProvide a better understanding of the relation between structural and microbiological characterization of artherial catheter biofilm in ICU patients using D-FF-OCT

Secondary

MeasureTime frameDescription
Bacterial or fungal indentificationOutcome measure is assessed 2 days following catheter removalIdentification and enumeration of species - whether bacterial or fungal - by mass spectrometry from culture in agar medium of biofilm samples
Biofilm thickness, measured with D-FF-OCTOutcome measure is assessed 2 days following catheter removalProvide a better understanding of the relation between thickness and microbiological characterization of artherial catheter biofilm in ICU patients using D-FF-OCT
Biofilm dynamic signal distribution, measured with D-FF-OCTOutcome measure is assessed 2 days following catheter removalProvide a better understanding of the relation between dynamic signal distribution and microbiological characterization of artherial catheter biofilm in ICU patients using D-FF-OCT

Countries

France

Contacts

CONTACTFlorian PERRAUD
florian.perraud@ch-chalon.fr06 78 58 85 19
CONTACTThomas MALDINEY
thomas.maldiney@ch-chalon.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026