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

Completed

• Conditions: Central Venous Catheter Associated Bloodstream Infection; Healthcare Associated Infection; Critically Ill
• Interventions: Other: D-FF-OCT analysis of CVC

• Registration Number: NCT06216080
• Lead Sponsor: Centre Hospitalier William Morey - Chalon sur Saône

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-01
• Status Verified: 2024-01
• Study First Submitted: 2024-01-01
• Study First Submitted QC: 2024-01-11
• Study First Posted: 2024-01-22
• Primary Completion: 2024-12-30
• Study Completion: 2025-02-10
• Last Update Submitted: 2025-02-16
• Last Update Posted: 2025-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OCT-BIO-CVC cohort	D-FF-OCT analysis of CVC	Adult critically ill patients (\> 18 years of age) exposed to central venous catheter for at least two calendar days

Primary Outcome Measures

Name	Time	Method
D-FF-OCT-based biofilm structure type	At Day 0, within 24h following catheter removal	Biofilm structure type (ribbon-shaped or mushroom-shaped), measured with D-FF-OCT

Secondary Outcome Measures

Name	Time	Method
D-FF-OCT-based biofilm thickness	At Day 0, within 24h following catheter removal	Biofilm thickness, measured with D-FF-OCT
D-FF-OCT-based dynamic signal distribution	At Day 0, within 24h following catheter removal	Biofilm dynamic signal distribution, measured with D-FF-OCT

Trial Locations

Locations (1)

William Morey General Hospital (Chalon-sur-Saône); 🇫🇷 Chalon sur Saône, Saône-et-Loire, France