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

NCT06379139 | Recruiting

• 1 other identifier: MALDINEY J'InvEst-I 2022
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 2

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

Conditions

Healthcare Associated Infection; Critically Ill; Endotracheal Tube

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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

Interventions

•Dynamic Full-Field Optical Coherence Tomography analysis of endotracheal tube OTHER

Dynamic full-field optical coherence tomography analysis of endotracheal tube sections to better apprehend strucural characterization of endotracheal tube-deposited biofilm

BIOPAVIR 2 cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Patient unable to declare their nonobjection
• Patient whose endotracheal tube collection is impossible
• Patient whose endotracheal tube is collected following self-extubation (sample contamination)

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (2)

CH William Morey

Chalon-sur-Saône, France

RECRUITING

CHU Dijon Bourgogne

Dijon, France

RECRUITING

MeSH Terms

Conditions

Cross Infection; Critical Illness

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas MALDINEY

  CH William Morey

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas MALDINEY

CONTACT

385910474; thomas.maldiney@ch-chalon71.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: April 23, 2024
• Study Start: March 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: April 23, 2024

Record last verified: 2024-04

Locations

FR (2)