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Dynamic Full-Field Optical Coherence Tomography for Structural and Microbiological Characterization of Central Venous Catheter-deposited Biofilm in Critically Ill Patients

Dynamic Full-Field Optical Coherence Tomography for Structural and Microbiological Characterization of Central Venous Catheter-deposited Biofilm in Critically Ill Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06216080
Acronym
OCT-BIO-CVC
Enrollment
50
Registered
2024-01-22
Start date
2023-05-01
Completion date
2025-02-10
Last updated
2025-02-18

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

Conditions

Central Venous Catheter Associated Bloodstream Infection, Critically Ill, Healthcare Associated Infection

Brief summary

29.3% of bacteremias in intensive care units (ICU) are linked to vascular devices, with a significant proportion related to central venous catheters, and an influence on both morbility and mortality. It is now accepted that microbiological biofilm plays a key role on both bacterial and fungal 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. We assume that a more precise characterization of central venous catheter-deposited biofilm could help us better understand invasive medical device-related healthcare infections in critically ill patients.

Interventions

OTHERD-FF-OCT analysis of CVC

Dynamic full-field optical coherence tomography analysis of central venous catheter sections to better apprehend strucural characterization of central venous catheter-deposited biofilm

Sponsors

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

Study design

Observational model
COHORT
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 nonobjection * Patient over 18 years of age * Patient exposed to central venous catheter for at least two calendar days

Exclusion criteria

* Patient unable to declare their nonobjection * Patient whose central venous catheter collection is impossible * Patient admitted in ICU with a central venous catheter already in place

Design outcomes

Primary

MeasureTime frameDescription
D-FF-OCT-based biofilm structure typeAt Day 0, within 24h following catheter removalBiofilm structure type (ribbon-shaped or mushroom-shaped), measured with D-FF-OCT

Secondary

MeasureTime frameDescription
D-FF-OCT-based biofilm thicknessAt Day 0, within 24h following catheter removalBiofilm thickness, measured with D-FF-OCT
D-FF-OCT-based dynamic signal distributionAt Day 0, within 24h following catheter removalBiofilm dynamic signal distribution, measured with D-FF-OCT

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026