Skip to main content
OpenTrials
Completed

NCT Number: NCT06216080

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthcare Associated Infection Central Venous Catheter Associated Bloodstream Infection Critical Illness Critically Ill Cross Infection Disease Attributes Iatrogenic Disease Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

William Morey General Hospital (Chalon-sur-Saône)

Chalon-sur-Saône, Saône-et-Loire, 71100, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

D-FF-OCT analysis of CVC

Other

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

Primary outcomes

  1. D-FF-OCT-based biofilm structure type

    Time frame: At Day 0, within 24h following catheter removal

    Biofilm structure type (ribbon-shaped or mushroom-shaped), measured with D-FF-OCT

Secondary outcomes

  1. D-FF-OCT-based biofilm thickness

    Time frame: At Day 0, within 24h following catheter removal

    Biofilm thickness, measured with D-FF-OCT

  2. D-FF-OCT-based dynamic signal distribution

    Time frame: At Day 0, within 24h following catheter removal

    Biofilm dynamic signal distribution, measured with D-FF-OCT

Sponsors and collaborators

Lead sponsor

Centre Hospitalier William Morey - Chalon sur Saône

Other

Collaborators

  • Centre Hospitalier Universitaire Dijon

Registry information

Acronym: OCT-BIO-CVC

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jan 22, 2024
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.