RHEOREA
Study of the Variation in Viscoelastic Properties of Pulmonary Mucus in Patients Undergoing Mechanical Ventilation With or Without NIV
Sponsor study identifier
Secondary identifiers
OTHER · ANSM
observational
20
1 country
1
Study Start
March 8, 2025
Actual (reported)Primary Completion
March 13, 2026
Actual (reported)Study Completion
March 13, 2026
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 13, 2026
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 8, 2025
Actual (reported)March 3, 2026
Actual (reported)March 13, 2026
Actual (reported)March 13, 2026
Actual (reported)March 24, 2026
Actual (reported)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
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
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.
Ventilated patient in intensive care in the hospital of Aix-en-Provence
CHI Aix-Pertuis
Aix-en-Provence, Recherche, 13100, France
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
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.
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.
20 participants (actual enrollment reported by the registry).
First Submitted
March 3, 2026
First Posted
March 24, 2026
Study Start
March 8, 2025
Actual (reported)Contact the study team to confirm eligibility.
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.
Primary Completion
March 13, 2026
Actual (reported)Study Completion
March 13, 2026
Actual (reported)Last Updated
August 18, 2026
Record last verified: 2026-08
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