Dynamic Full-field Optical Coherence Tomography for Structural and Microbiological Characterization of Endotracheal Tube Biofilm in Critically Ill Patients (BIOPAVIR2)

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

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

Study Overview

• Status: Recruiting
• Conditions: Critically Ill; Endotracheal Tube; Healthcare Associated Infection
• Intervention / Treatment: Other: •Dynamic Full-Field Optical Coherence Tomography analysis of endotracheal tube

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Thomas MALDINEY; Phone Number: +33 385910474; Email: thomas.maldiney@ch-chalon71.fr

Study Locations

• France
  • Chalon-sur-Saône, France
    • Recruiting
    • CH William Morey
    • Contact: Thomas MALDINEY; Email: thomas.maldiney@ch-chalon71.fr
  • Dijon, France
    • Recruiting
    • CHU Dijon Bourgogne
    • Contact: Jean Pierre QUENOT; Email: jean-pierre.quenot@chu-dijon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
BIOPAVIR 2 cohort; 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon
• Investigators: Principal Investigator: Thomas MALDINEY, CH William Morey

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: April 4, 2024
• First Submitted That Met QC Criteria: April 22, 2024
• First Posted (Actual): April 23, 2024

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Disease Attributes; Iatrogenic Disease; Critical Illness; Cross Infection
• Other Study ID Numbers: MALDINEY J'InvEst-I 2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No