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Clinical Trials/NCT06838598
NCT06838598RecruitingNot Applicable

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

Centre Hospitalier William Morey - Chalon sur Saône2 sites in 1 country60 target enrollmentStarted: June 3, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
60
Locations
2
Primary Endpoint
Biofilm structure type (ribbon-shaped or mushroom-shaped), measured with D-FF-OCT

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

Arms & Interventions

OCT-BIO-KTA cohort

Critically ill patient > 18 years of age with artherial catheter for >2 calendar days in ICU

Intervention: OCT-BIO-KTA cohort (Other)

Outcomes

Primary Outcomes

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

Time Frame: Outcome measure is assessed 2 days following catheter removal

Provide a better understanding of the relation between structural and microbiological characterization of artherial catheter biofilm in ICU patients using D-FF-OCT

Secondary Outcomes

  • Bacterial or fungal indentification(Outcome measure is assessed 2 days following catheter removal)
  • Biofilm thickness, measured with D-FF-OCT(Outcome measure is assessed 2 days following catheter removal)
  • Biofilm dynamic signal distribution, measured with D-FF-OCT(Outcome measure is assessed 2 days following catheter removal)

Investigators

Sponsor
Centre Hospitalier William Morey - Chalon sur Saône
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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