An observational study in Healthcare Associated Infection, Critically Ill and Endotracheal Tube, sponsored by Centre Hospitalier Universitaire Dijon. Recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-23.
Sponsored by Centre Hospitalier Universitaire Dijon · Observational
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
239 studies on the registry are indexed under Cross Infection; 48 are open to participants now.
This study's planned enrollment of 80 is below the median of 400 across 97 observational studies indexed under Cross Infection.
Browse Cross Infection studies →Centre Hospitalier Universitaire Dijon is the lead sponsor of 495 studies on the registry; 105 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient over 18 years of age having declared their nonobjection and exposed to mechanical ventilation for at least two calendar days
Exclusion Criteria:
Adult critically ill patients (\> 18 years of age) exposed to endotracheal tube for at least two calendar days
Other: •Dynamic Full-Field Optical Coherence Tomography analysis of endotracheal tube
Dynamic full-field optical coherence tomography analysis of endotracheal tube sections to better apprehend strucural characterization of endotracheal tube-deposited biofilm
Dynamic Full-Field Optical Coherence Tomography-based biofilm structure type
shape data
Time frame: At Day 0, within 72hours following endothracheal tube removal
type of microbiological associated with each shape
Time frame: At Day 0, within 72hours following endothracheal tube removal
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Centre Hospitalier Universitaire Dijon