protocolSection identificationModule nctId: NCT06379139, orgStudyIdInfo id: MALDINEY J'InvEst-I 2022, briefTitle: Dynamic Full-field Optical Coherence Tomography for Structural and Microbiological Characterization of Endotracheal Tube Biofilm in Critically Ill Patients, acronym: BIOPAVIR2, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire Dijon, class: OTHER, descriptionModule briefSummary: 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, conditionsModule conditions: Healthcare Associated Infection, conditions: Critically Ill, conditions: Endotracheal Tube, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: •Dynamic Full-Field Optical Coherence Tomography analysis of endotracheal tube, outcomesModule primaryOutcomes measure: Dynamic Full-Field Optical Coherence Tomography-based biofilm structure type, primaryOutcomes measure: type of microbiological associated with each shape, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CH William Morey, status: RECRUITING, city: Chalon-sur-Saône, country: France, contacts name: Thomas MALDINEY, role: CONTACT, email: thomas.maldiney@ch-chalon71.fr, geoPoint lat: 46.78333, lon: 4.85, locations facility: CHU Dijon Bourgogne, status: RECRUITING, city: Dijon, country: France, contacts name: Jean Pierre QUENOT, role: CONTACT, email: jean-pierre.quenot@chu-dijon.fr, geoPoint lat: 47.31667, lon: 5.01667, hasResults: False