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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier William Morey - Chalon sur Saône

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • OCT-BIO-KTA cohort

    Other intervention

    Dynamic full-field optical coherence tomography (D-FF-OCT) analysis of arterial catheter sections before microbiological analysis of catheter biofilm

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: OCT-BIO-KTA cohort1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Outcome measure is assessed 2 days following catheter removal

Secondary outcomes

1

Bacterial or fungal indentification

Identification and enumeration of species - whether bacterial or fungal - by mass spectrometry from culture in agar medium of biofilm samples

Time frame
Outcome measure is assessed 2 days following catheter removal
2

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

Time frame
Outcome measure is assessed 2 days following catheter removal
3

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

Time frame
Outcome measure is assessed 2 days following catheter removal

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier William Morey - Chalon sur Saône

Lead sponsor

Centre Hospitalier Universitaire Dijon

Collaborator

Centre Hospitalier Macon

Collaborator