Dynamic Full-field Optical Coherence Tomography for Structural and Microbiological Characterization of Endotracheal Tube Biofilm in Critically Ill Patients

Critically Ill Clinical Trial

— BIOPAVIR2  

Official title:

Dynamic Full-field Optical Coherence Tomography for Endotracheal Tube Biofilm Characterization in Critically Ill Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06379139
• Other study ID #: MALDINEY J'InvEst-I 2022
• Status: Recruiting
• Start date: March 1, 2024
• Est. completion date: March 2025

Study information

• Verified date: April 2024
• Source: Centre Hospitalier Universitaire Dijon
• Contact: Thomas MALDINEY
• Phone: 385910474
• Email: thomas.maldiney[@]ch-chalon71.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill
• Cross Infection
• Endotracheal Tube
• Healthcare Associated Infection

Intervention

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

Locations

Country	Name	City	State
France	CH William Morey	Chalon-sur-Saône
France	CHU Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dynamic Full-Field Optical Coherence Tomography-based biofilm structure type	shape data	At Day 0, within 72hours following endothracheal tube removal
Primary	type of microbiological associated with each shape		At Day 0, within 72hours following endothracheal tube removal