Ventilated Patient in Intensive CareRHEOREANCT07490028
Variation in Viscoelastic Properties of Pulmonary Mucus in Patients Undergoing Mechanical Ventilation
An observational study of Ventilated Patient in Intensive Care, run by Centre Hospitalier Intercommunal Aix-Pertuis at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilated Patient in Intensive Care
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 8 Mar 2025to 13 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Ventilated patient in intensive care in the hospital of Aix-en-Provence
Who may be able to join
- 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
Who cannot join
- Pregnant or breastfeeding women
- Patients deprived of their liberty, under guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Variation in Viscoelastic Properties of Pulmonary Mucus in Patients Undergoing Mechanical Ventilation With or Without NIV
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.
Read more
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.
Read the detailed description
Nowadays, micro-rheological analyses make it possible to accurately measure the viscoelastic properties of mucus directly at the patient's bedside. These tools offer a unique opportunity to explore bronchial secretions as an element for early diagnosis, monitoring and personalisation of FMAP treatments.
These analyses are based on mucus sampling, which is performed by bronchial aspiration. This is a simple, quick procedure that is commonly performed on demand in intensive care units to prevent complications, particularly airway obstruction.
There are no prospective studies on specific rheological markers in the prediction of FMAP, making it necessary to explore their role in the pathophysiology, diagnosis and management of this condition in greater depth.
- Conditions
- Ventilated Patient in Intensive Care
- Keywords
- viscoelastic properties, mucus, mechanical ventilation, ventilator-associated pneumonia
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe changes in the viscoelastic properties of mucus over time in patients on mechanical ventilation
Measured: 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
Measured: 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
Measured: 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
Measured: one year
Enable early bacterial identification by rheological signature
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start8 Mar 2025
- Primary completion13 Mar 2026
- Study completion13 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ventilated Patient in Intensive CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Aix-Pertuis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Olivier BALDESI, Centre Hospitalier Intercommunal Aix-Pertuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07490028
- Sponsor's protocol ID
- 20241213-16
- Other IDs
- 2024-A02744-43
- Acronym
- RHEOREA
- Status last verified
- Aug 2026
- First submitted
- 3 Mar 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24404129Patarin 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.
PubMed 32973305Fromentin 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.
PubMed 33559707
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Variation in Viscoelastic Properties of Pulmonary Mucus in Patients Undergoing Mechanical Ventilation With or Without NIV
- ClinicalTrials.gov ID
- NCT07490028
- Acronym / sponsor ID
- RHEOREA / 20241213-16
- Conditions
- Ventilated Patient in Intensive Care
- Keywords
- viscoelastic properties, mucus, mechanical ventilation, ventilator-associated pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal Aix-PertuisUniversity, hospital or other
- Study start
- 8 Mar 2025 (actual)
- Primary completion
- 13 Mar 2026 (actual)
- Study completion
- 13 Mar 2026 (actual)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Nowadays, micro-rheological analyses make it possible to accurately measure the viscoelastic properties of mucus directly at the patient's bedside. These tools offer a unique opportunity to explore bronchial secretions as an element for early diagnosis, monitoring and personalisation of FMAP treatments.
These analyses are based on mucus sampling, which is performed by bronchial aspiration. This is a simple, quick procedure that is commonly performed on demand in intensive care units to prevent complications, particularly airway obstruction.
There are no prospective studies on specific rheological markers in the prediction of FMAP, making it necessary to explore their role in the pathophysiology, diagnosis and management of this condition in greater depth.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ventilated patient in intensive care in the hospital of Aix-en-Provence
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnant or breastfeeding women
- Patients deprived of their liberty, under guardianship or curatorship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Describe changes in the viscoelastic properties of mucus over time in patients on mechanical ventilation
Time frame: From date of initiation of mechanical ventilation up to the date of extubation or tracheostomy decannulation, assessed up to 30 days
4 secondary outcomes
Highlight a correlation between changes in viscoelastic characteristics and the secondary onset of PAVM
Time frame: 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
Time frame: 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
Time frame: one year
Enable early bacterial identification by rheological signature
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- BackgroundPatarin 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: PubMed 24404129Tomaiuolo 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.
- Background: PubMed 32973305Patarin 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.
- Background: PubMed 33559707Fromentin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilated Patient in Intensive Care, run by Centre Hospitalier Intercommunal Aix-Pertuis at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe changes in the viscoelastic properties of mucus over time in patients on mechanical ventilation (time frame: From date of initiation of mechanical ventilation up to the date of extubation or tracheostomy decannulation, assessed up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07490028, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.