Clinical trial NCT06379139: Dynamic Full-field Optical Coherence Tomography for Structural and Microbiological Characterization of Endotracheal Tube Biofilm in Critically Ill Patients
Official title: Dynamic Full-field Optical Coherence Tomography for Endotracheal Tube Biofilm Characterization in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Healthcare Associated Infection
Critically Ill
Endotracheal Tube
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2024-04-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient over 18 years of age having declared their nonobjection and exposed to mechanical ventilation for at least two calendar days

Brief summary: Biofilm is a microstructure organised into aggregates of microbiological species within a polymeric matrix. As early as the 2000s, the Centers for Disease Control and Prevention (CDC) recognised the possible role of the biofilm lining endotracheal endotracheal tubes in the development of ventilator-associated pneumonia (VAP) , the most common infection in intensive care, with a high morbidity and mortality rate and a significant increase in hospital costs.

Targeting biofilm therefore now appears to be a new area of interest for limiting the risk of VAP, and this rationale has led to the development of an intraluminal for abrading biofilm deposited on the inside of the intubation probe

. Evaluation of this type of strategy nevertheless justifies the introduction of more precise methods for characterisation of the biofilm.

To this end, the investigator carried out an initial clinical study describing the biofilm on intubation probes, BIOPAVIR 1, showing the existence of several biofilm structures, each associated with a specific microbiological signature. Several limitations including a lack of power due to an insufficient number of patients and the use of number of patients, and the use of a confocal microscopy technique with poor axial without the possibility of acquiring metabolic images of the biofilm.

Based on the previous description of biofilm by optical coherence tomography (OCT), and a recent experience with an optimised form of high-resolution OCT, called full-field OCT, the investigator hypothesise that full-field OCT will allow more accurate characterisation of biofilm, due to its high spatial resolution and its potential ability to capture metabolic activity in the biofilm BIOPAVIR 2 proposes to use the performance of full-field OCT to better characterise the biofilm lining endotracheal tubes in patients undergoing mechanical ventilation in intensive care units. This project represents a first step towards understanding the link between the development of biofilm on intubation and the occurrence of VAP


Eligibility criteria: Inclusion Criteria:

* Patient or relative informed of the study and having declared their nonobjection
* Patient over 18 years of age
* Patient exposed to mechanical ventilation for at least two calendar days

Exclusion Criteria:

* Patient unable to declare their nonobjection
* Patient whose endotracheal tube collection is impossible
* Patient whose endotracheal tube is collected following self-extubation (sample contamination)

Primary outcomes:
measure: Dynamic Full-Field Optical Coherence Tomography-based biofilm structure type
timeFrame: At Day 0, within 72hours following endothracheal tube removal
measure: type of microbiological associated with each shape
timeFrame: At Day 0, within 72hours following endothracheal tube removal
Secondary outcomes:
Other outcomes:
Locations:
city: Chalon-sur-Saône
country: France
facility: CH William Morey
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
affiliation: CH William Morey
name: Thomas MALDINEY
role: PRINCIPAL_INVESTIGATOR
References: