Structural and Microbiological Characterization of Arterial Catheter Biofilm in ICU's Patients Using Optical Coherence Tomography (OCT-BIO-KTA)

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.

Study Overview

• Status: Recruiting
• Conditions: Bacteremia; Tomography, Optical Coherence; Biofilms; Arterial Catheterization, Peripheral
• Intervention / Treatment: Other: OCT-BIO-KTA cohort

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Florian PERRAUD; Phone Number: 06 78 58 85 19; Email: florian.perraud@ch-chalon.fr
• Study Contact Backup: Name: Thomas MALDINEY; Email: thomas.maldiney@ch-chalon.fr

Study Locations

• France
  • Bourgogne-Franche-Comté
    • Dijon, Bourgogne-Franche-Comté, France, 21000
      • Recruiting
      • CHU Dijon Bourgogne
      • Contact: QUENOT Jean Pierre, MD-PhD; Email: jean-pierre.quenot@chu-dijon.fr
    • Mâcon, Bourgogne-Franche-Comté, France, 71000
      • Recruiting
      • CH Mâcon
      • Contact: MAILLET Thibault, MD; Email: thmaillet@ch-macon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient over 18 years of age with artherial catheter more than 2 calendar days

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
OCT-BIO-KTA cohort; Critically ill patient > 18 years of age with artherial catheter for >2 calendar days in ICU	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biofilm structure type (ribbon-shaped or mushroom-shaped), measured with D-FF-OCT	Provide a better understanding of the relation between structural and microbiological characterization of artherial catheter biofilm in ICU patients using D-FF-OCT	Outcome measure is assessed 2 days following catheter removal

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bacterial or fungal indentification	Identification and enumeration of species - whether bacterial or fungal - by mass spectrometry from culture in agar medium of biofilm samples	Outcome measure is assessed 2 days following catheter removal
Biofilm thickness, measured with D-FF-OCT	Provide a better understanding of the relation between thickness and microbiological characterization of artherial catheter biofilm in ICU patients using D-FF-OCT	Outcome measure is assessed 2 days following catheter removal
Biofilm dynamic signal distribution, measured with D-FF-OCT	Provide a better understanding of the relation between dynamic signal distribution and microbiological characterization of artherial catheter biofilm in ICU patients using D-FF-OCT	Outcome measure is assessed 2 days following catheter removal

Collaborators and Investigators

• Sponsor: Centre Hospitalier William Morey - Chalon sur Saône
• Collaborators: Centre Hospitalier Universitaire Dijon; Centre Hospitalier Macon

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: August 21, 2024
• First Submitted That Met QC Criteria: February 16, 2025
• First Posted (Actual): February 20, 2025

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Bacterial Infections; Bacterial Infections and Mycoses; Pathological Conditions, Signs and Symptoms; Bacteremia
• Other Study ID Numbers: OCT-BIO-KTA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No