Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06379139
Status:
RECRUITING
Last Update Posted:
2024-04-23
First Post:
2024-04-04
Brief Title:
Dynamic Full-field Optical Coherence Tomography for Structural and Microbiological Characterization of Endotracheal Tube Biofilm in Critically Ill Patients
Sponsor:
Centre Hospitalier Universitaire Dijon
Organization:
Centre Hospitalier Universitaire Dijon
Study Overview
Official Title:
Dynamic Full-field Optical Coherence Tomography for Endotracheal Tube Biofilm Characterization in Critically Ill Patients
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BIOPAVIR2
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None