Variation in Viscoelastic Properties of Pulmonary Mucus in Patients Undergoing Mechanical Ventilation

NCT07490028 | Recruiting

• 2 other identifiers: 20241213-162024-A02744-43
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Ventilator-associated pneumonia (VAP) is defined as an infection of the lung parenchyma in patients undergoing invasive mechanical ventilation for at least 48 hours. It is one of the types of pneumonia acquired in intensive care units (ICUs) and is one of the most common infections in this population, representing a major complication. The diagnosis of VAP is based on three main criteria: clinical suspicion, adiological imaging, and microbiological cultures of the lower respiratory tract. However, these elements have significant limitations. New rapid diagnostic techniques, such as multiplex polymerase chain reaction (PCR), can quickly identify pathogens and resistance mechanisms in just a few hours. These promising tools could reduce the time to initiate targeted treatment while limiting the excessive use of antibiotics. However, no single tool is currently accurate enough to diagnose VAP, and diagnosis is based on a combination of factors. Today, scores exist that can be used to assess the probability of PAVM, such as the CIPS. These are useful tools but lack specificity. The clinical, biological and radiological criteria used to calculate the score can also be observed in other pathologies. Thus, although they are sensitive to the detection of PAVM, they are often insufficient to establish a definitive diagnosis. They must be supplemented by other diagnostic approaches, such as microbiological cultures and more detailed imaging examinations, to obtain a more accurate assessment. It is also essential to mention the importance of gaining a better understanding of the lung microbiome. Indeed, it appears to play a central role not only in the pathophysiology of MVAP, but also in its diagnosis and management. The work of Fromentin et al. shows that it is possible to observe dysbiosis associated with a loss of microbial diversity and the onset of certain pulmonary infections. Thus, structural variations in mucus could reflect changes in the pulmonary microbiome. It is therefore essential to remember that mucus plays an essential protective role in the respiratory tract by trapping particles, bacteria and pathogens, while facilitating their transport thanks to its viscoelastic properties. However, in mechanically ventilated patients, these mucociliary clearance mechanisms are often impaired, promoting the accumulation of secretions, bacterial proliferation and, ultimately, the onset of MVAP. The work of Patarin and Giovanna and al. suggests that biochemical and microbiological changes in mucus could be a criterion for initiating treatment in recurrent pulmonary infections in patients with chronic obstructive pulmonary disease (COPD) or cystic fibrosis. These observations suggest the potential value of early characterisation of mucus in ventilated patients in order to detect additional diagnostic clues that would enable rapid and appropriate treatment.

Conditions

Ventilated Patient in Intensive Care

Keywords

viscoelastic properties; mucus; mechanical ventilation; ventilator-associated pneumonia

Outcome Measures

Primary Outcomes (1)

• Describe changes in the viscoelastic properties of mucus over time in patients on mechanical ventilation

  From date of initiation of mechanical ventilation up to the date of extubation or tracheostomy decannulation, assessed up to 30 days

Secondary Outcomes (4)

• Highlight a correlation between changes in viscoelastic characteristics and the secondary onset of PAVM

  From date of initiation of mechanical ventilation up to the date of extubation or tracheostomy decannulationn assessed up to 30 days

• Highlight that changes in the viscoelastic properties of mucus precede the onset and therefore the diagnosis of PAVM

  From date of initiation of mechanical ventilation up to the date of extubation or tracheostomy decannulationn assessed up to 30 days

• Propose a threshold for variation in viscoelastic parameters that allows patients with PAVM to be distinguished from those who do not develop it

  one year

• Enable early bacterial identification by rheological signature

  one year

Study Arms (1)

secreting patient

Tracheobronchial suction is performed on request through the intubation tube or tracheotomy cannula to collect this mucus. Instead of being discarded, this sample will be stored. Within one hour of collection, the viscoelastic characteristics of this mucus will be studied. This analysis can only be performed once per day per patient. Samples will be collected daily until mechanical ventilation is discontinued.

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

Ventilated patient in intensive care in the hospital of Aix-en-Provence

You may qualify if:

• Adult patients (\> 18 years old)
• Hospitalised in the intensive care unit of the CHIAP
• Placed on mechanical ventilation, regardless of the length of hospitalisation before and after
• French-speaking patients, able to understand the study information leaflet
• No objection from the patient

You may not qualify if:

• Pregnant or breastfeeding women
• Patients deprived of their liberty, under guardianship or curatorship

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Aix-Pertuis: lead

Study Sites (1)

CHI Aix-Pertuis

Aix-en-Provence, Recherche, 13100, France

RECRUITING

Related Publications (4)

• Patarin J, Ghiringhelli E, Cracowski C, Camara B. Change of mucus rheology in patients with Cystic Fibrosis, COPD and Asthma. Conf paper. 2018 Sep. doi: 10.1183/13993003.congress-2018.PA5051

  BACKGROUND

• Tomaiuolo G, Rusciano G, Caserta S, Carciati A, Carnovale V, Abete P, Sasso A, Guido S. A new method to improve the clinical evaluation of cystic fibrosis patients by mucus viscoelastic properties. PLoS One. 2014 Jan 3;9(1):e82297. doi: 10.1371/journal.pone.0082297. eCollection 2014.

  PMID: 24404129 BACKGROUND

• Patarin J, Ghiringhelli E, Darsy G, Obamba M, Bochu P, Camara B, Quetant S, Cracowski JL, Cracowski C, Robert de Saint Vincent M. Rheological analysis of sputum from patients with chronic bronchial diseases. Sci Rep. 2020 Sep 24;10(1):15685. doi: 10.1038/s41598-020-72672-6.

  PMID: 32973305 BACKGROUND

• Fromentin M, Ricard JD, Roux D. Respiratory microbiome in mechanically ventilated patients: a narrative review. Intensive Care Med. 2021 Mar;47(3):292-306. doi: 10.1007/s00134-020-06338-2. Epub 2021 Feb 9.

  PMID: 33559707 BACKGROUND

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Olivier BALDESI, Dr

CONTACT

+33442339812; obaldesi@ch-aix.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 24, 2026
• Study Start: March 8, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 24, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)